Communist Chinese Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents

 

Order of the State Administration for Market Regulation

No. 48

The "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents", which were adopted at the 11th executive meeting of the State Administration for Market Regulation on July 22, 2021, are hereby promulgated and shall come into force on October 1, 2021.

Zhang Gong

August 26, 2021

Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents

Chapter 1 General Provisions

Article 1　In order to regulate the registration and filing of in-vitro diagnostic reagents and ensure the safety, effectiveness and quality control of in-vitro diagnostic reagents, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.

Article 2　These Measures shall apply to the registration, filing and supervision and administration of in vitro diagnostic reagents within the territory of the People's Republic of China.

Article 3　The term "in vitro diagnostic reagents" as mentioned in these Measures refers to the in vitro diagnostic reagents managed as medical devices, including those used in vitro for human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation. The detection reagents, kits, calibrators, quality control products and other products can be used alone or in combination with instruments, appliances, equipment or systems.

The in vitro diagnostic reagents used for blood source screening and the in vitro diagnostic reagents labeled with radionuclides under drug management do not belong to the management scope of these Measures.

Article 4 The　registration of in vitro diagnostic reagents means that the applicant for the registration of in vitro diagnostic reagents (hereinafter referred to as the applicant) submits an application for the registration of in vitro diagnostic reagents in accordance with legal procedures and requirements. Activities such as validity and quality controllability are reviewed to decide whether to approve the application.

The filing of in vitro diagnostic reagents refers to the activities in which the filing person of in vitro diagnostic reagents (hereinafter referred to as the filing person) submits filing materials to the drug regulatory authority in accordance with legal procedures and requirements, and the drug regulatory authority archives the submitted filing materials for future reference.

Article 5 The　State Drug Administration is in charge of the administration of the registration and filing of in vitro diagnostic reagents nationwide, and is responsible for establishing a management system for the registration and filing of in vitro diagnostic reagents. Evaluation and approval, filing of imported first-class in vitro diagnostic reagents and related supervision and management work, and supervision and guidance for the registration and filing of local in vitro diagnostic reagents.

Article 6 The　Medical Device Evaluation Center of the State Drug Administration (hereinafter referred to as the National Bureau of Device Evaluation Center) is responsible for the registration application, registration modification application, and registration renewal of the domestic Class III and imported Class II and III in vitro diagnostic reagent products Technical review of applications, etc.

Medical Device Standard Management Center of the State Drug Administration, China National Institute for Food and Drug Control, Food and Drug Inspection Center of the State Drug Administration (hereinafter referred to as the National Bureau Review and Inspection Center), Drug Evaluation Center of the State Drug Administration, State Drug Administration The Administrative Matters Acceptance Service and Complaint and Reporting Center of the Administration, the Information Center of the State Drug Administration and other professional and technical institutions shall, according to their duties, undertake the standard management, classification and definition, inspection, verification, and monitoring of in vitro diagnostic reagents required for the implementation of the supervision and management of in vitro diagnostic reagents. Work related to evaluation, certificate delivery, and corresponding information construction and management.

Article 7 The　drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the administration of the registration of the following in vitro diagnostic reagents within their respective administrative regions:

(1) The review and approval of the domestic second-class in vitro diagnostic reagent registration;

(2) Verification of the quality management system of the second and third types of in vitro diagnostic reagents in China;

(3) To organize medical device clinical trial institutions and supervision and management of clinical trials in accordance with the law;

(4) Supervision and guidance for the filing of Category I in vitro diagnostic reagents within the territory of the department responsible for drug supervision and administration at the city level with districts.

The specialized technical institutions for medical devices established or designated by the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall undertake the work of technical review, inspection, verification, monitoring and evaluation required for the implementation of the supervision and management of in vitro diagnostic reagents.

The department in charge of drug supervision and administration at the city level with districts shall be responsible for the filing and management of the domestic first-class in vitro diagnostic reagent products.

Article 8 The　registration and filing of in vitro diagnostic reagents shall follow the principles of lawfulness, science, openness, fairness and impartiality.

Article 9　The first category of in vitro diagnostic reagents shall be subject to product filing management. Category II and Category III in vitro diagnostic reagents are subject to product registration management.

For the filing of domestic first-class in-vitro diagnostic reagents, the filing person submits filing materials to the department responsible for drug supervision and administration at the districted city level.

The domestic Class II in vitro diagnostic reagents shall be reviewed by the drug regulatory department of the province, autonomous region or municipality directly under the Central Government, and a medical device registration certificate shall be issued after approval.

The domestic third-class in vitro diagnostic reagents are reviewed by the State Drug Administration, and a medical device registration certificate is issued after approval.

For the filing of imported Class I in vitro diagnostic reagents, the filing person submits filing materials to the State Drug Administration.

The import of Class II and Class III in vitro diagnostic reagents shall be reviewed by the State Drug Administration, and a medical device registration certificate shall be issued after approval.

Article 10 In- 　vitro diagnostic reagent registrants and filers shall strengthen the quality management of in-vitro diagnostic reagents in the whole life cycle, and undertake the safety, effectiveness and quality controllability of in-vitro diagnostic reagents in the whole process of development, production, operation and use according to law. responsibility.

Article 11　The State Drug Administration shall give priority to examination and approval of in vitro diagnostic reagents urgently needed in clinical practice, and implement special examination and approval of innovative in vitro diagnostic reagents. Encourage the research and innovation of in vitro diagnostic reagents, and promote the high-quality development of the medical device industry.

Article 12 The　State Drug Administration shall establish and improve in vitro diagnostic reagent standards, technical guidelines and other systems in accordance with the law, standardize in vitro diagnostic reagent technical review and quality management system verification, and guide and serve in vitro diagnostic reagent research and development and registration applications.

Article 13 The　drug regulatory department shall disclose the relevant information on the registration and filing of in vitro diagnostic reagents in a timely manner in accordance with the law. Applicants can inquire about the approval progress and results, and the public can check the approval results.

Without the consent of the applicant, the drug regulatory authorities, professional technical institutions and their staff, experts participating in the review and other personnel shall not disclose the commercial secrets, undisclosed information or confidential business information submitted by the applicant or filing person, unless otherwise provided by law or Except those involving national security and major social and public interests.

Chapter II Basic Requirements

Article 14 The　registration and filing of in vitro diagnostic reagents shall abide by relevant laws, regulations, rules, and mandatory standards, follow the basic principles of safety and performance of in vitro diagnostic reagents, and refer to relevant technical guidelines to prove that the registered and filed in vitro diagnostic reagents are safe, Effective, quality controllable, to ensure that the information is true, accurate, complete and traceable.

Article 15 The　applicant and filing party shall be an enterprise or research and development institution that can bear the corresponding legal responsibility.

Overseas applicants and filing parties should designate an enterprise legal person within China as an agent to handle the registration and filing of relevant in vitro diagnostic reagents. The agent shall assist the registrant and filer in fulfilling the obligations stipulated in the first paragraph of Article 20 of the Regulations on the Supervision and Administration of Medical Devices, and assist the overseas registrant and filer in fulfilling the corresponding legal responsibilities.

Article 16 The　applicant and filing party shall establish a quality management system related to product development and production, and maintain effective operation.

Article 17　Personnel handling the registration and filing of in-vitro diagnostic reagents shall have relevant professional knowledge and be familiar with the laws, regulations, rules and relevant provisions on registration management of in-vitro diagnostic reagents registration and filing.

Article 18 When　applying for registration or filing, relevant materials shall be submitted in accordance with the relevant registration and filing requirements of the State Drug Administration, and the applicant and filing person shall be responsible for the authenticity of the materials.

The registration and filing materials shall be in Chinese. If the translation is based on foreign language materials, the original text should be provided at the same time. When citing unpublished literature materials, the documents that have been approved by the owner of the materials should be provided.

Article 19 To　apply for the registration of imported in vitro diagnostic reagents and to go through the filing of imported in vitro diagnostic reagents, the applicant and the filing party shall submit the certification documents that the competent authorities of the country (region) where the applicant or the filing person is registered or the place of production has approved the marketing and sales.

If the country (region) where the applicant or filer is registered or the place of production does not manage the product as a medical device, the applicant and filer need to provide relevant documents, including the country (region) where the place of registration or the place of production allows the product to be marketed Proof of sale.

In-vitro diagnostic reagents approved in accordance with the innovative product registration procedures that are not listed in the applicant or filer's registration place or the country (region) where the production place is located do not need to submit relevant documents.

Article 20　In vitro diagnostic reagents shall meet applicable mandatory standards. If the product structure features, technical principles, intended use, and usage methods are inconsistent with the scope of application of the mandatory standards, the applicant and filing party shall state that the mandatory standards are not applicable, and provide relevant materials.

Where there are no mandatory standards, applicants and filers are encouraged to adopt recommended standards.

Article 21 The　registration and filing of in vitro diagnostic reagents shall comply with the relevant requirements of the classification rules and catalogues of in vitro diagnostic reagents.

Article 22 The　drug regulatory authorities continue to promote the reform of the review and approval system, strengthen regulatory scientific research, establish a technical system for the registration and management of in vitro diagnostic reagents, which is dominated by technical review and supported by verification, inspection, monitoring and evaluation, and optimizes Review and approve the process, improve the review and approval capability, and improve the quality and efficiency of the review and approval.

Article 23　Medical device professional technical institutions shall establish and improve communication and exchange systems, clarify the form and content of communication and exchange, and organize communication and exchanges with applicants according to work needs.

Article 24　Medical device professional and technical institutions shall establish an expert consultation system according to work needs, listen to expert opinions on major issues in the process of review, verification, inspection, etc., and give full play to the technical support role of experts.

Chapter 3 In Vitro Diagnostic Reagent Registration

Section 1 Product Development

Article 25 The　development of in vitro diagnostic reagents shall follow the principles of risk management, take into account the existing recognized technical level, ensure that all known and foreseeable risks and unintended effects of products are minimized and acceptable, and ensure that the benefits of products in normal use are greater than risk.

Article 26　The research and experimental activities of in vitro diagnostic reagent products shall meet the requirements of relevant laws, regulations and mandatory standards of China.

Article 27 The　applicant and filing party shall formulate product technical requirements for in vitro diagnostic reagents applying for registration or filing.

Product technical requirements mainly include functional, safety indicators and detection methods of finished in vitro diagnostic reagents that can be objectively determined.

The main raw materials and production process requirements shall be specified in the form of an appendix in the product technical requirements for the third category of in vitro diagnostic reagents.

In vitro diagnostic reagents shall meet the technical requirements for registered or filed products.

Article 28　Applicants and filing parties shall prepare product instructions and labels for in vitro diagnostic reagents applying for registration or filing.

Product instructions and labels shall comply with Article 39 of the Regulations on the Supervision and Administration of Medical Devices and relevant regulations.

Article 29 In the 　development of in vitro diagnostic reagents, non-clinical research on in vitro diagnostic reagents shall be carried out according to the intended use and technical characteristics of the product.

Non-clinical research refers to the test or evaluation of in vitro diagnostic reagents under laboratory conditions, including research on the selection and preparation of main raw materials, product production process, product analytical performance, positive judgment value or reference interval, and product stability.

When applying for registration or filing, the non-clinical evidence generated in the research and development activities shall be submitted.

Article 30　The functional and safety indicators and methods determined in the non-clinical research process of in vitro diagnostic reagents shall be compatible with the expected use conditions and purposes of the product, and the research samples shall be representative and typical. When necessary, methodological validation and statistical analysis should be carried out.

Article 31　When applying for registration or filing, an inspection shall be conducted in accordance with the technical requirements of the product, and an inspection report shall be submitted. Only those who pass the inspection can conduct clinical trials or apply for registration and filing.

Article 32 When the　same registration application includes different packaging specifications, the inspection of only one packaging specification product may be carried out. The inspection products shall be able to represent the safety and effectiveness of the registered or filed products, and their production shall meet the requirements of medical devices. Relevant requirements of production quality management practices.

Article 33　The inspection report submitted for registration or filing may be the self-inspection report of the applicant or the filing person, or the inspection report issued by a qualified medical device inspection agency.

The third category of in vitro diagnostic reagents shall provide inspection reports of 3 different production batches.

Article 34　If there are applicable national standards, the reagents shall be tested using the national standards. China National Institute for Food and Drug Control is responsible for organizing the preparation and calibration of national standards.

The second clinical evaluation

Article 35　Clinical evaluation of in vitro diagnostic reagents refers to the process of using scientific and reasonable methods to analyze and evaluate clinical data, and confirm whether the product meets the requirements for use or intended use, so as to prove the safety and effectiveness of in vitro diagnostic reagents. .

Article 36　Clinical trials of in vitro diagnostic reagents refer to systematic studies on the clinical performance of in vitro diagnostic reagents in the corresponding clinical environment.

The State Drug Administration formulates guidelines for clinical trials of in vitro diagnostic reagents, specifying requirements for conducting clinical trials and writing requirements for clinical trial reports.

Article 37 To　conduct clinical evaluation of in vitro diagnostic reagents, clinical trials shall be conducted to prove the safety and effectiveness of in vitro diagnostic reagents.

Those who meet the following circumstances may be exempted from clinical trials:

(1) The reaction principle is clear, the design is finalized, and the production process is mature, and the same variety of in vitro diagnostic reagents that have been on the market have been clinically used for many years without serious adverse event records, and the routine use has not been changed;

(2) It can be proved that the in vitro diagnostic reagent is safe and effective by comparing the methodology of the same variety.

The catalogues of Category II and Category III in vitro diagnostic reagents exempt from clinical trials shall be formulated, adjusted and published by the State Drug Administration.

Article 38 For　in vitro diagnostic reagents exempted from clinical trials, the applicant shall prove the safety and effectiveness of the products by comparing the methodology of the clinical samples with the intended use.

The State Drug Administration has formulated relevant guidelines for the clinical evaluation of in vitro diagnostic reagents exempt from clinical trials.

Article 39 The　clinical evaluation data of in vitro diagnostic reagents refer to the documents formed by the applicant's clinical evaluation.

For clinical trials, clinical trial materials include clinical trial protocols, ethics committee opinions, informed consent, clinical trial reports, and relevant data.

For in vitro diagnostic reagents that are exempt from clinical trials, the clinical evaluation data includes comparative analysis with similar marketed products, methodological comparison data, relevant literature data analysis and empirical data analysis, etc.

Article 40　When the same registration application includes different packaging specifications, only one packaging specification may be used for clinical evaluation, and the product for clinical evaluation shall represent the safety and effectiveness of the product applied for registration or filing.

Application for registration of calibrators and quality control products alone does not require the submission of clinical evaluation data.

Article 41　The clinical trials of in vitro diagnostic reagents shall be conducted in accordance with the requirements of the Good Management Practice for Medical Device Clinical Trials, in medical device clinical trial institutions that have the corresponding conditions and are filed in accordance with the regulations. Before the start of a clinical trial, the sponsor of the clinical trial shall file a clinical trial record with the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where it is located. The production of in vitro diagnostic reagents for clinical trials shall comply with the relevant requirements of the Good Manufacturing Practice for Medical Devices.

Article 42　For serious adverse events related to in vitro diagnostic reagents in clinical trials, or other serious safety risk information that occurs during the clinical trials of in vitro diagnostic reagents, the sponsor of the clinical trial shall, in accordance with relevant requirements, report to the locality and the province where the clinical trial institution is located. , autonomous regions and municipalities directly under the Central Government drug supervision and administration departments, and take risk control measures. Where risk control measures are not taken, the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall order the sponsor to take corresponding risk control measures in accordance with the law.

Article 43 When　serious adverse events related to in vitro diagnostic reagents for large-scale clinical trials or other major safety problems occur in the clinical trials of in vitro diagnostic reagents, the sponsor shall suspend or terminate the clinical trials of in vitro diagnostic reagents, and report to the locality and the clinical trial respectively. Report from the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the institution is located. If it is not suspended or terminated, the drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall order the sponsor to take corresponding risk control measures according to law.

Article 44 When　conducting clinical evaluation of in-vitro diagnostic reagents that are expected to be used by consumers themselves, the applicant shall also evaluate the cognitive ability of consumers without medical background to the product instructions.

Article 45　For in vitro diagnostic reagents that are undergoing clinical trials for diagnosing serious life-threatening diseases for which there is no effective diagnostic method, the patients may benefit from medical observation. The clinical trials of in vitro diagnostic reagents are used free of charge in other patients with the same condition, and their safety data can be used in the application for the registration of in vitro diagnostic reagents.

Section 3 Registration System Verification

Article 46 The　applicant shall submit the relevant information on the quality management system related to product development and production when applying for registration. The drug regulatory department that accepts the registration application deems it necessary to check the quality management system during the technical review of the product. , should organize the inspection of the quality management system, and can access the original data as needed.

Article 47 The　inspection of the quality management system of the domestic third-class in vitro diagnostic reagents shall be carried out by the drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government where the applicant is located.

The inspection of the quality management system of the domestic second-class in vitro diagnostic reagents shall be organized and carried out by the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the applicant is located.

Article 48 The　drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government carry out quality management system inspections in accordance with the requirements of the medical device production quality management standard, focusing on whether the applicant has established a quality suitable for the product in accordance with the requirements of the medical device production quality management standard. The management system, as well as the design and development, production management and quality control related to product development and production are checked.

During the verification process, the authenticity of inspection products and clinical trial products should be verified at the same time, focusing on reviewing the relevant records of the design and development process, as well as the relevant records of the production process of inspection products and clinical trial products.

Where a self-inspection report is submitted, a key inspection shall be conducted on the inspection capability and inspection results of the applicant, filing person or entrusted institution during the research and development process.

Article 49 The　drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government may conduct quality management system verification by means of document review or on-site inspection. According to the specific situation of the applicant, the supervision and inspection situation, and the comparison of the production conditions and process between the products applied for registration and the products that have passed the inspection in the past, etc., determine whether to conduct an on-site inspection and the content of the inspection, so as to avoid repeated inspections.

Article 50　When the National Bureau of Device Evaluation Center conducts technical review of imported Class II and Class III in vitro diagnostic reagents, if it deems it necessary to conduct a quality management system inspection, it shall notify the National Bureau of Inspection and Inspection Center to conduct inspections according to relevant requirements.

Section 4 Product Registration

Article 51　The applicant shall submit an application for the registration of in vitro diagnostic reagents after completing the safety and effectiveness research supporting the registration of in vitro diagnostic reagents and be ready to accept the inspection of the quality management system, and through the online registration application in accordance with relevant requirements Submit the following registration application materials to the drug regulatory authorities through other channels:

(1) Product risk analysis data;

(2) Product technical requirements;

(3) Product inspection report;

(4) Clinical evaluation data;

(5) Product instructions and label samples;

(6) Quality management system documents related to product development and production;

(7) Other materials required to prove the safety and effectiveness of the product.

Article 52　After receiving the application, the drug regulatory department shall review the application materials and deal with it according to the following circumstances:

(1) If the application matters fall within the scope of the administrative organ’s powers, and the application materials are complete and meet the requirements of formal examination, the application shall be accepted;

(2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;

(3) If the application materials are incomplete or do not conform to the statutory form, the applicant shall be notified on the spot or within 5 days of all the contents that need to be supplemented and corrected.

(4) If the application matters do not fall within the scope of the administrative organ's functions and powers according to law, it shall immediately make a decision not to accept it, and inform the applicant to apply to the relevant administrative organ.

When the drug regulatory department accepts or rejects an application for the registration of in vitro diagnostic reagents, it shall issue a notice of acceptance or rejection affixed with the special seal of the administrative organ and dated.

After the application for registration of in vitro diagnostic reagents is accepted, if the applicant is required to pay the fee, the applicant shall pay the fee as required. If the applicant fails to pay the fee within the prescribed time limit, the applicant shall be deemed to have withdrawn the application voluntarily, and the drug regulatory authority shall terminate the registration procedure.

Article 53 If　the applicant needs to supplement and correct materials during the technical review process, the technical review agency shall inform all the contents that need to be supplemented and corrected at one time. The applicant shall, within 1 year of receiving the notice of supplementation and correction, provide supplementary materials as required by the notification of supplementation and correction once; the technical review agency shall complete the technical review within the specified time limit after receiving the supplementary materials.

If the applicant has any objection to the content of the supplementary notice, he may submit a written opinion to the corresponding technical review institution, explain the reasons and provide corresponding technical support materials.

If the applicant fails to submit supplementary materials within the time limit, the technical review will be terminated, and the drug regulatory department will make a decision not to register.

Article 54　For a registration application that has been accepted, the applicant may, before the administrative licensing decision is made, apply to the drug regulatory department that accepted the application for withdrawal of the registration application and related materials, and explain the reasons. If it agrees to withdraw the application, the drug regulatory authority shall terminate its registration procedure.

In the process of review, verification and approval, if suspected of concealing the truth or providing false information and other illegal acts, it shall be dealt with in accordance with the law, and the applicant shall not withdraw the registration application.

Article 55　For an accepted registration application, if there is evidence that the registration application materials may be false, the drug regulatory department may suspend the review and approval. After verification, continue to review or make a decision not to register according to the verification conclusion.

Article 56　During the review of an application for in vitro diagnostic reagent registration, if the review conclusion is to be rejected, the technical review agency shall inform the applicant of the reasons for the failure, and the applicant may submit a proposal to the technical review agency within 15 days. Objection, the content of objection is limited to the original application matters and original application materials. The technical review agency will conduct a comprehensive evaluation based on the applicant's objections and give feedback to the applicant. The objection processing time is not included in the review time limit.

Article 57　The drug regulatory department that accepts the registration application shall make a decision on whether to approve or not after the technical review is completed. For those that meet the requirements of safety, effectiveness, and quality control, the registration is approved, and a medical device registration certificate is issued. The approved product technical requirements and product instructions are issued to the applicant in the form of attachments. If the registration is not approved, the reasons shall be explained in writing, and the applicant shall be informed of the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law.

The medical device registration certificate is valid for 5 years.

Article 58　In case of any of the following circumstances for an accepted registration application, the drug regulatory department shall make a decision not to register and notify the applicant:

(1) The applicant's research on the safety, efficacy and quality controllability of the in vitro diagnostic reagents to be marketed and the results thereof cannot prove that the products are safe, effective and quality controllable;

(2) The quality management system verification fails, and the applicant refuses to accept the on-site inspection of the quality management system;

(3) The registration application materials are false;

(4) The content of the registration application materials is confusing and contradictory, the content of the registration application materials is obviously inconsistent with the application items, and it cannot prove that the product is safe, effective and quality controllable;

(5) Other circumstances under which registration is not granted.

Article 59　Regarding the matters that laws, regulations and rules stipulate for the implementation of administrative licensing, or other major administrative licensing matters that involve public interests that the drug regulatory department deems to require a hearing, the drug regulatory department shall announce to the public and hold a hearing. . Where an application for medical device registration directly involves a major interest relationship between the applicant and others, the drug regulatory department shall inform the applicant and interested parties that they have the right to request a hearing before making an administrative licensing decision.

Article 60　For urgently needed in-vitro diagnostic reagents used for rare diseases, serious life-threatening diseases for which no effective diagnostic methods are available, and for responding to public health events, the drug regulatory department may make a conditional approval decision, which will be approved in the medical device registration certificate. The relevant matters such as the validity period, the research work that needs to be completed after the listing, and the completion time limit are stated in the document.

Article 61　For in vitro diagnostic reagents approved with conditions, the registrant shall collect data on benefits and risks after the in vitro diagnostic reagents are marketed, continuously monitor and evaluate the benefits and risks of the products, take effective measures to actively control risks, and Complete the research and submit relevant materials as required within the prescribed time limit.

Article 62　For the conditionally approved in vitro diagnostic reagents, if the registrant fails to complete the research as required or cannot prove that the benefits outweigh the risks, the registrant shall apply for the cancellation of the medical device registration certificate in a timely manner, and the drug regulatory department may Cancellation of the medical device registration certificate.

Article 63　For newly developed in vitro diagnostic reagents that have not been included in the classification catalogue of in vitro diagnostic reagents, the applicant may directly apply for the registration of the third category of in vitro diagnostic reagent products, or may judge the product category according to the classification rules and submit it to the State Drug Administration. After the bureau's application category is confirmed, apply for product registration or record product.

For direct application for the registration of the third category of in vitro diagnostic reagents, the State Drug Administration shall determine the category according to the degree of risk. If the domestic in-vitro diagnostic reagents are determined to be Class II or Class I, the applicant shall be notified to apply for registration or filing with the corresponding drug regulatory authority.

Article 64 For　registered in vitro diagnostic reagents, if the management category is adjusted from high category to low category, the medical device registration certificate will continue to be valid within the validity period. If the validity period expires and needs to be renewed, the registrant shall apply to the corresponding drug regulatory authority for registration renewal or filing according to the adjusted category 6 months before the validity period of the medical device registration certificate expires.

If the management category of in vitro diagnostic reagents is adjusted from a low category to a high category, the registrant shall apply for registration to the corresponding drug regulatory department according to the changed category. The State Drug Administration shall specify the time limit for completing the adjustment in the management category adjustment notice.

Article 65 If the　medical device registration certificate and its accessories are lost or damaged, the registrant shall apply to the original certificate issuing authority for reissuance, and the original certificate issuing authority shall issue a reissue after verification.

Article 66　Where a patent dispute occurs during the examination of a registration application or after it is approved, it shall be handled in accordance with the provisions of relevant laws and regulations.

Chapter IV Special Registration Procedures

Section 1 Innovative Product Registration Procedure

Article 67 For　in vitro diagnostic reagents that meet the following requirements, the applicant may apply for the innovative product registration procedure:

(1) The applicant, through its leading technological innovation activities, legally owns the invention patent right of the core technology of the product in China, or obtains the invention patent right or the right to use it in China through assignment in accordance with the law, and the time for applying for the application of the innovative product registration procedure is within Within 5 years from the date of the patent grant announcement; or the application for a core technology invention patent has been published by the patent administration department of the State Council, and a search report has been issued by the Patent Search and Consulting Center of the State Intellectual Property Office, stating that the core technology solution of the product is novel and creative;

(2) The applicant has completed the preliminary research of the product and has basic finalized products, the research process is real and controlled, and the research data is complete and traceable;

(3) The main working principle or mechanism of action of the product is the first in China, the product performance or safety is fundamentally improved compared with similar products, the technology is at the international leading level, and it has significant clinical application value.

Article 68　To apply for the application of innovative product registration procedures, the applicant shall submit an application for review of innovative medical devices to the State Drug Administration after the product is basically finalized. The State Drug Administration will organize experts to review, and those that meet the requirements will be included in the registration process of innovative products.

Article 69　For the registration application of in-vitro diagnostic reagents applicable to the registration procedure of innovative products, the State Drug Administration and institutions undertaking relevant technical work shall designate special persons to be responsible according to their respective responsibilities, communicate in a timely manner, and provide guidance.

For in vitro diagnostic reagents included in the innovative product registration process, the National Bureau of Device Evaluation Center can discuss major technical issues, major safety issues, clinical trial plans, stages in product development with the applicant before the registration application is accepted and during the technical review process. Communicate and communicate on the summary and evaluation of the results of sexual clinical trials.

Article 70 If　the applicant voluntarily requests termination of the in vitro diagnostic reagents included in the innovative product registration process or the State Drug Administration finds that it no longer meets the requirements of the innovative product registration process, the State Drug Administration may terminate the innovative product registration process for the relevant product and inform the applicant.

Article 71　For in vitro diagnostic reagents included in the innovative product registration procedure, if the applicant fails to file an application for registration within the prescribed time limit, the innovative product registration procedure is no longer applicable.

Section 2 Priority Registration Procedures

Article 72　In vitro diagnostic reagents that meet any of the following conditions may apply for priority registration procedures:

(1) Diagnosing rare diseases and malignant tumors, and has obvious clinical advantages, diagnosing diseases unique to the elderly and frequently-occurring diseases and there is currently no effective diagnosis method, dedicated to children and has obvious clinical advantages, or clinically urgent and there is no similar variety in my country. The medical device for which the product is approved for registration;

(2) Medical devices included in major national science and technology projects or national key R&D plans;

(3) Other medical devices prescribed by the State Drug Administration that can be subject to the priority registration procedure.

Article 73　To apply for the priority registration procedure, the applicant shall submit an application for the priority registration procedure to the State Drug Administration when applying for the registration of in vitro diagnostic reagents. If it falls under the first item of Article 72, the State Drug Administration will organize experts to review it. If it meets the requirements, it will be included in the priority registration procedure; if it falls under the second item of Article 72, the State Drug Evaluation Center will After review, if it conforms, it will be included in the priority registration procedure; if it falls under the third circumstance of Article 72, the State Drug Administration will listen to opinions widely, and organize experts to discuss whether it will be included in the priority registration procedure.

Article 74　For the registration applications of in-vitro diagnostic reagents included in the priority registration procedure, the State Drug Administration shall give priority to review and approval, and the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall give priority to the inspection of the registration quality management system.

During the technical review process of the medical device products included in the priority registration procedure, the National Bureau of Device Evaluation Center shall actively communicate with the applicant in accordance with relevant regulations, and may arrange special exchanges when necessary.

Section 3 Emergency Registration Procedures

Article 75 The　State Drug Administration may respond to public health emergencies in accordance with the law and there are no similar products on the market in China, or although similar products have been marketed in China, the supply of products cannot meet the requirements of public health emergencies. Emergency registration of in vitro diagnostic reagents required for emergency handling of incidents.

Article 76 To　apply for the emergency registration procedure, the applicant shall submit an emergency registration application to the State Drug Administration. Those who meet the conditions will be included in the emergency registration process.

Article 77　For in vitro diagnostic reagent registration applications for emergency registration, the State Drug Administration shall handle in-vitro diagnostic reagent product inspection, system verification, technical review, etc.

Chapter 5 Change of Registration and Renewal of Registration

Section 1 Change of Registration

Article 78 The　registrant shall take the initiative to conduct post-marketing research on in vitro diagnostic reagents, further confirm the safety, effectiveness and quality controllability of in vitro diagnostic reagents, and strengthen the continuous management of marketed in vitro diagnostic reagents.

If the design, raw materials, production process, scope of application, and method of use of the registered in vitro diagnostic reagent products of the second and third categories have undergone substantial changes, which may affect the safety and effectiveness of the in vitro diagnostic reagents, the registrant shall report to the original product. The registration department applies for changing the registration formalities; if there are other changes, it shall file with the original registration department within 30 days from the date of the change.

The product name, packaging specifications, main components, intended use, product technical requirements, product instructions, and the production address of imported in vitro diagnostic reagents, etc., as stated in the registration certificate, belong to the matters that need to be changed for registration as stipulated in the preceding paragraph. The name and domicile of the registrant, the name and domicile of the agent, etc., are matters that need to be filed as prescribed in the preceding paragraph. If the production address of domestic in vitro diagnostic reagents is changed, the registrant shall go through the recordation after the corresponding change of production license.

In case of other changes, the registrant shall do a good job in the relevant work in accordance with the requirements of the quality management system, and report to the drug supervision and administration department in accordance with the regulations.

Article 79 The　registered in vitro diagnostic reagents of the second and third categories have substantial changes in the core technical principles of the products, or other major changes, which have a major impact on the safety and effectiveness of the products, and substantially constitute new If the product does not belong to the change application items stipulated in this chapter, it shall be handled in accordance with the provisions of the registration application.

Article 80　For a registration modification application, the technical review agency shall focus on reviewing the changed parts, and form review opinions on whether the changed products are safe, effective and controllable in quality.

During the technical review of the application for registration modification, if it is deemed necessary to check the quality management system, the drug supervision and administration department shall organize the inspection of the quality management system.

Article 81　The registration document of medical device modification shall be used in combination with the original medical device registration certificate, and the expiration date of validity shall be the same as that of the original medical device registration certificate.

Section 2 Continuation of Registration

Article 82 If the 　medical device registration certificate expires and needs to be renewed, the registrant shall apply to the original registration department for renewal of registration 6 months before the expiration of the medical device registration certificate, and submit application materials in accordance with relevant requirements.

Except for the circumstances specified in Article 83 of these Measures, the drug regulatory department that receives the application for registration renewal shall make a decision to approve the renewal before the expiration of the validity period of the medical device registration certificate. If a decision is not made within the time limit, it will be deemed as granting a continuation.

Article 83　The renewal of registration shall not be granted under any of the following circumstances:

(1) Failure to file an application for renewal of registration within the prescribed time limit;

(2) The new mandatory standards for in vitro diagnostic reagents or national standards are issued and implemented, and the in vitro diagnostic reagents applying for renewal of registration cannot meet the new requirements;

(3) For in vitro diagnostic reagents approved with conditions, the items stated in the medical device registration certificate have not been completed within the prescribed time limit.

Article 84　If the approval time for renewal of registration is within the validity period of the original registration certificate, the starting date of the validity period of the registration certificate for renewal of registration shall be the day after the expiry date of the original registration certificate; The date of validity of the certificate shall be the date of approval of the renewal of registration.

Article 85 For　the acceptance and examination and approval procedures of in-vitro diagnostic reagent change registration applications and registration renewal applications, if there are no provisions in this chapter, the relevant provisions of Chapter III of these Measures shall apply.

Chapter VI Filing of In Vitro Diagnostic Reagents

Article 86　Before the production of Category I in vitro diagnostic reagents, product filing shall be carried out.

Article 87 For the filing of 　in vitro diagnostic reagents, the filing person shall submit the filing materials to the drug regulatory department in accordance with the provisions of the Regulations on the Supervision and Administration of Medical Devices, and obtain the filing number.

Article 88　If there are changes in the contents of the filed in vitro diagnostic reagents, the contents of the filing information form and the technical requirements of the filed products, the filing person shall change the filing with the original filing department, and submit an explanation of the changes and relevant documents. The drug regulatory department shall publish the changes in the filing information.

Article　89 Where the management category of the in-vitro diagnostic reagents that have been filed is adjusted to the second or third category of in-vitro diagnostic reagents, an application for registration shall be applied in accordance with the provisions of these Measures.

Chapter VII Working Time Limit

Article 90　The time limit stipulated in these measures is the longest time for the acceptance, technical review, verification, approval and other work of in vitro diagnostic reagent registration. The working time limit related to the special registration procedure shall be implemented in accordance with the relevant provisions of the special registration procedure.

Professional and technical institutions such as the National Bureau of Device Evaluation Center shall clarify the work procedures and time limit of their own units, and announce to the public.

Article 91　After receiving the application for the registration of in vitro diagnostic reagents, the drug regulatory department shall transfer the application materials to the technical review agency within 3 days from the date of acceptance.

Article 92　The time limit for technical review of in vitro diagnostic reagent registration shall be implemented in accordance with the following provisions:

(1) The time limit for the technical review of the application for the registration of the second category of in vitro diagnostic reagents, the application for registration change, and the application for renewal of registration is 60 days, and the time limit for the technical review after the application materials are supplemented and corrected is 60 days;

(2) The time limit for technical review of the third category in vitro diagnostic reagent registration application, registration modification application, and registration renewal application is 90 days, and the technical review time limit after application materials are supplemented and corrected is 60 days.

Article 93　The time limit for the inspection of the quality management system of the third category in vitro diagnostic reagents in China shall be implemented in accordance with the following provisions:

(1) The National Bureau of Device Evaluation Center shall notify the relevant provincial, autonomous region and municipal drug administration departments to start the inspection within 10 days after the application for in vitro diagnostic reagent registration is accepted;

(2) The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government shall, in principle, complete the inspection within 30 days after receiving the inspection notice, and feed back the inspection situation, inspection results and other relevant materials to the National Bureau of Device Evaluation Center.

Article 94　The drug regulatory department that accepts the registration application shall make a decision within 20 days from the date of receiving the review comments.

Article 95 The　drug regulatory department shall issue and serve relevant administrative licenses within 10 days from the date of making the decision on the approval of the registration of in vitro diagnostic reagents.

Article 96　If it is really necessary to extend the time limit due to special circumstances such as product characteristics and technical review, verification and other work, the extension time limit shall not exceed half of the original time limit. After the person in charge approves it, the technical institution that extends the time limit shall notify the applicant in writing, and notify other relevant technical institutions.

Article 97　The original certificate-issuing authority shall reissue the medical device registration certificate within 20 days from the date of receipt of the application for re-issuing the medical device registration certificate.

Article 98 The　following hours are not included in the relevant work time limit:

(1) The time occupied by the applicant for supplementary materials, rectification after verification, etc.;

(2) The time for delaying the verification due to the applicant's reasons;

(3) Time for external expert consultation, expert consultation meeting, and joint review with drug review institutions;

(4) If the review and approval procedures are suspended according to regulations, the time occupied during the suspension of the review and approval procedures;

(5) Time occupied by the quality management system verification.

Article 99　The time limit stipulated in these Measures shall be calculated in working days.

Chapter VIII Supervision and Management

Article 100 The　drug regulatory department shall strengthen the supervision and inspection of the research and development activities of in vitro diagnostic reagents, and may conduct extended inspections of units and individuals that provide products or services for the research and development of in vitro diagnostic reagents, and relevant units and individuals shall cooperate and provide relevant information. Documents and materials shall not be rejected, concealed, or obstructed.

Article 101 The　State Drug Administration establishes and implements the unique identification system for medical devices step by step. Applicants and filers shall submit information related to the unique identification in accordance with relevant regulations to ensure the authenticity, accuracy and traceability of the data.

Article 102　The State Drug Administration shall promptly notify the drug administration department of the province, autonomous region, or municipality directly under the Central Government where the agent is located. The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government conduct daily supervision and management of agents within their respective administrative regions.

Article 103　The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall, according to the filing status of medical device clinical trial institutions, organize post-filing supervision and inspection of clinical trial institutions that have been filed within their respective administrative regions. For newly filed medical device clinical trial institutions, supervision and inspection shall be carried out within 60 days after filing.

The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall organize daily supervision and inspection of the compliance of medical device clinical trial institutions within their respective administrative regions with the quality management standards for medical device clinical trials, and supervise their continuous compliance with the prescribed requirements. The State Drug Administration shall supervise and inspect medical device clinical trial institutions as needed.

Article 104 The　drug regulatory authorities may conduct on-site inspections of the authenticity, accuracy, completeness, standardization and traceability of clinical trials when deemed necessary.

Article 105　If the drug regulatory department responsible for the filing of Class I in vitro diagnostic reagent products finds that the filing materials are not standardized during the post-filing supervision, it shall order the filing person to make corrections within a time limit.

Article 106 If　the drug regulatory department fails to timely discover the systemic and regional risks in the registration management of in vitro diagnostic reagents within the administrative region, or fails to eliminate the systemic and regional hidden dangers of the registration management of in vitro diagnostic reagents within the administrative region in a timely manner, The higher-level drug supervision and administration department may interview the main person in charge of the lower-level drug supervision and administration department.

Chapter IX Legal Liability

Article 107　Those who violate the provisions of Article 78 of these Measures and fail to file the changes as required shall be ordered to make corrections within a time limit; those who fail to make corrections within the time limit shall be fined not less than 10,000 yuan but not more than 30,000 yuan.

Article 108 Those　who conduct clinical trials of in vitro diagnostic reagents without complying with the clinical trial quality management practices shall be punished in accordance with Article 94 of the Regulations on the Supervision and Administration of Medical Devices.

Article 109 If the 　medical device technical review institution fails to perform its duties in accordance with the provisions of these Measures, resulting in major mistakes in the review work, the department in charge of drug supervision and administration shall order it to make corrections, circulate criticism and give warnings; if serious consequences are caused, the The legal representative, main responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall be punished according to law.

Article 110　The staff members of the departments in charge of drug supervision and administration who violate the regulations, abuse their powers, neglect their duties, or practice favoritism and fraud shall be punished according to law.

Chapter 10 Supplementary Provisions

Article 111　The naming of in vitro diagnostic reagents shall follow the following principles:

The product name of in vitro diagnostic reagents generally consists of three parts. The first part: the name of the substance to be tested; the second part: the use, such as assay kits, quality control materials, etc.; the third part: the method or principle, such as magnetic particle chemiluminescence immunoassay, fluorescence PCR method, fluorescence in situ hybridization law, etc., this section should be listed in parentheses.

If there are many components of the test substance or there are other special circumstances, the product-related indication name or other alternative name can be used.

The first category of products, calibrators, and quality controls, are named according to their intended use.

Article 112　The registration or filing unit of in vitro diagnostic reagents shall be a single reagent or a single kit, and a registration or filing unit may include different packaging specifications.

Calibrators and quality control products can be combined with the in vitro diagnostic reagents used in combination for registration, or they can be registered separately.

Article 113 The　approved in-vitro diagnostic reagents refer to the in-vitro diagnostic reagents produced within the validity period of the medical device registration certificate, which are consistent with the limited content of the medical device registration certificate and its attachments.

Article 114　The independent reagent components stated in the "Main Components" column of the medical device registration certificate, which are used in the original registered product, may be sold separately.

Article 115 An　applicant may, with the authorization of the owner of the medical device master file, cite the registered medical device master file when applying for in vitro diagnostic reagent product registration or modification registration. The master file of a medical device shall be registered by its owner or agency, and the relevant work procedures shall be stipulated separately.

Article 116 The　format of the medical device registration certificate shall be uniformly formulated by the State Drug Administration.

The arrangement of the registration certificate number is as follows:

×1 Mechanical Note × 2 × × × × 3 × 4 × × 5 × × × × 6. in:

×1 is the abbreviation of the location of the registration approval department:

The domestic third-class in vitro diagnostic reagents, imported second-class and third-class in-vitro diagnostic reagents are the word "country";

Domestic Category II in vitro diagnostic reagents are the abbreviations of the provinces, autonomous regions and municipalities directly under the Central Government where the registration approval authority is located;

×2 is the registration form:

The word "quasi" applies to domestic in vitro diagnostic reagents;

The word "jin" applies to imported in vitro diagnostic reagents;

The word "Xu" is applicable to in vitro diagnostic reagents in Hong Kong, Macau and Taiwan;

××××3 is the year of first registration;

×4 is the product management category;

××5 is the product classification code;

××××6 is the serial number for the first registration.

For continued registration, the numbers of ××××3 and ××××6 remain unchanged. If the product management category is adjusted, it shall be renumbered.

Article 117　The arrangement of the record number of the Class I medical device is as follows:

×1Mechanical equipment××××2××××3. in:

×1 is the abbreviation of the location of the filing department:

Imported in vitro diagnostic reagents of the first category are the word "country";

The first category of in vitro diagnostic reagents in China is the abbreviation of the province, autonomous region, and municipality directly under the Central Government where the filing department is located plus the abbreviation of the city-level administrative region divided into districts (if there is no corresponding city-level administrative region divided into districts, it is only the abbreviation of the province, autonomous region, or municipality directly under the Central Government) ;

××××2 is the filing year;

××××3 is the record serial number.

Article 118 The　electronic documents and paper documents of the medical device registration certificate and modification registration documents produced by the drug regulatory department have the same legal effect.

Article 119　According to the needs of the work, the State Drug Administration may entrust the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government, technical institutions, or social organizations to undertake relevant specific work.

Article 120　The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government may formulate special registration procedures for Class II in vitro diagnostic reagents within their respective administrative regions with reference to Chapter IV of these Measures, and report to the State Drug Administration for the record.

Article 121 The　charging items and charging standards for the registration of in vitro diagnostic reagent products shall be implemented in accordance with the relevant regulations of the financial and pricing departments of the State Council.

Article 122　The relevant provisions on the emergency use of in vitro diagnostic reagents shall be formulated separately by the State Drug Administration in conjunction with relevant departments.

Article 123　For the in vitro diagnostic reagents developed by medical institutions according to the clinical needs of their own units and used in their own units under the guidance of licensed physicians, the relevant management regulations shall be governed by the State Drug Administration To be formulated separately in conjunction with relevant departments.

Article 124　The registration and filing of in vitro diagnostic reagents in Hong Kong, Macau and Taiwan shall be handled with reference to imported in vitro diagnostic reagents.

Article 125　These Measures shall come into force on October 1, 2021. On July 30, 2014, the "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" promulgated by Order No. 5 of the former State Food and Drug Administration shall be repealed at the same time.

国家市场监督管理总局令

第　48　号

《体外诊断试剂注册与备案管理办法》已经2021年7月22日市场监管总局第11次局务会议通过，现予公布，自2021年10月1日起施行。

局　长　　张　工

2021年8月26日

体外诊断试剂注册与备案管理办法

第一章　总　　则

第一条　为了规范体外诊断试剂注册与备案行为，保证体外诊断试剂的安全、有效和质量可控，根据《医疗器械监督管理条例》，制定本办法。

第二条　在中华人民共和国境内开展体外诊断试剂注册、备案及其监督管理活动，适用本办法。

第三条　本办法所称体外诊断试剂，是指按医疗器械管理的体外诊断试剂，包括在疾病的预测、预防、诊断、治疗监测、预后观察和健康状态评价的过程中，用于人体样本体外检测的试剂、试剂盒、校准品、质控品等产品，可以单独使用，也可以与仪器、器具、设备或者系统组合使用。

按照药品管理的用于血源筛查的体外诊断试剂、采用放射性核素标记的体外诊断试剂不属于本办法管理范围。

第四条　体外诊断试剂注册是指体外诊断试剂注册申请人（以下简称申请人）依照法定程序和要求提出体外诊断试剂注册申请，药品监督管理部门依据法律法规，基于科学认知，进行安全性、有效性和质量可控性等审查，决定是否同意其申请的活动。

体外诊断试剂备案是指体外诊断试剂备案人（以下简称备案人）依照法定程序和要求向药品监督管理部门提交备案资料，药品监督管理部门对提交的备案资料存档备查的活动。

第五条　国家药品监督管理局主管全国体外诊断试剂注册与备案管理工作，负责建立体外诊断试剂注册与备案管理工作体系，依法组织境内第三类和进口第二类、第三类体外诊断试剂审评审批，进口第一类体外诊断试剂备案以及相关监督管理工作，对地方体外诊断试剂注册与备案工作进行监督指导。

第六条　国家药品监督管理局医疗器械技术审评中心（以下简称国家局器械审评中心）负责境内第三类和进口第二类、三类体外诊断试剂产品注册申请、变更注册申请、延续注册申请等的技术审评工作。

国家药品监督管理局医疗器械标准管理中心、中国食品药品检定研究院、国家药品监督管理局食品药品审核查验中心（以下简称国家局审核查验中心）、国家药品监督管理局药品评价中心、国家药品监督管理局行政事项受理服务和投诉举报中心、国家药品监督管理局信息中心等其他专业技术机构，依职责承担实施体外诊断试剂监督管理所需的体外诊断试剂标准管理、分类界定、检验、核查、监测与评价、制证送达以及相应的信息化建设与管理等相关工作。

第七条　省、自治区、直辖市药品监督管理部门负责本行政区域内以下体外诊断试剂注册相关管理工作：

（一）境内第二类体外诊断试剂注册审评审批；

（二）境内第二类、第三类体外诊断试剂质量管理体系核查；

（三）依法组织医疗器械临床试验机构以及临床试验的监督管理；

（四）对设区的市级负责药品监督管理的部门境内第一类体外诊断试剂备案的监督指导。

省、自治区、直辖市药品监督管理部门设置或者指定的医疗器械专业技术机构，承担实施体外诊断试剂监督管理所需的技术审评、检验、核查、监测与评价等工作。

设区的市级负责药品监督管理的部门负责境内第一类体外诊断试剂产品备案管理工作。

第八条　体外诊断试剂注册与备案遵循依法、科学、公开、公平、公正的原则。

第九条　第一类体外诊断试剂实行产品备案管理。第二类、第三类体外诊断试剂实行产品注册管理。

境内第一类体外诊断试剂备案，备案人向设区的市级负责药品监督管理的部门提交备案资料。

境内第二类体外诊断试剂由省、自治区、直辖市药品监督管理部门审查，批准后发给医疗器械注册证。

境内第三类体外诊断试剂由国家药品监督管理局审查，批准后发给医疗器械注册证。

进口第一类体外诊断试剂备案，备案人向国家药品监督管理局提交备案资料。

进口第二类、第三类体外诊断试剂由国家药品监督管理局审查，批准后发给医疗器械注册证。

第十条　体外诊断试剂注册人、备案人应当加强体外诊断试剂全生命周期质量管理，对研制、生产、经营、使用全过程中的体外诊断试剂的安全性、有效性和质量可控性依法承担责任。

第十一条　国家药品监督管理局对临床急需体外诊断试剂实行优先审批，对创新体外诊断试剂实行特别审批。鼓励体外诊断试剂的研究与创新，推动医疗器械产业高质量发展。

第十二条　国家药品监督管理局依法建立健全体外诊断试剂标准、技术指导原则等体系，规范体外诊断试剂技术审评和质量管理体系核查，指导和服务体外诊断试剂研发和注册申请。

第十三条　药品监督管理部门依法及时公开体外诊断试剂注册、备案相关信息，申请人可以查询审批进度和结果，公众可以查阅审批结果。

未经申请人同意，药品监督管理部门、专业技术机构及其工作人员、参与评审的专家等人员不得披露申请人或者备案人提交的商业秘密、未披露信息或者保密商务信息，法律另有规定或者涉及国家安全、重大社会公共利益的除外。

第二章　基本要求

第十四条　体外诊断试剂注册、备案，应当遵守相关法律、法规、规章、强制性标准，遵循体外诊断试剂安全和性能基本原则，参照相关技术指导原则，证明注册、备案的体外诊断试剂安全、有效、质量可控，保证信息真实、准确、完整和可追溯。

第十五条　申请人、备案人应当为能够承担相应法律责任的企业或者研制机构。

境外申请人、备案人应当指定中国境内的企业法人作为代理人，办理相关体外诊断试剂注册、备案事项。代理人应当依法协助注册人、备案人履行《医疗器械监督管理条例》第二十条第一款规定的义务，并协助境外注册人、备案人落实相应法律责任。

第十六条　申请人、备案人应当建立与产品研制、生产有关的质量管理体系，并保持有效运行。

第十七条　办理体外诊断试剂注册、备案事项的人员应当具有相关专业知识，熟悉体外诊断试剂注册、备案管理的法律、法规、规章和注册管理相关规定。

第十八条　申请注册或者进行备案，应当按照国家药品监督管理局有关注册、备案的要求提交相关资料，申请人、备案人对资料的真实性负责。

注册、备案资料应当使用中文。根据外文资料翻译的，应当同时提供原文。引用未公开发表的文献资料时，应当提供资料权利人许可使用的文件。

第十九条　申请进口体外诊断试剂注册、办理进口体外诊断试剂备案，应当提交申请人、备案人注册地或者生产地所在国家（地区）主管部门准许上市销售的证明文件。

申请人、备案人注册地或者生产地所在国家（地区）未将该产品作为医疗器械管理的，申请人、备案人需提供相关文件，包括注册地或者生产地所在国家（地区）准许该产品上市销售的证明文件。

未在申请人、备案人注册地或者生产地所在国家（地区）上市的按照创新产品注册程序审批的体外诊断试剂，不需提交相关文件。

第二十条　体外诊断试剂应当符合适用的强制性标准。产品结构特征、技术原理、预期用途、使用方式等与强制性标准的适用范围不一致的，申请人、备案人应当提出不适用强制性标准的说明，并提供相关资料。

没有强制性标准的，鼓励申请人、备案人采用推荐性标准。

第二十一条　体外诊断试剂注册、备案工作应当遵循体外诊断试剂分类规则和分类目录的有关要求。

第二十二条　药品监督管理部门持续推进审评审批制度改革，加强监管科学研究，建立以技术审评为主导，核查、检验、监测与评价等为支撑的体外诊断试剂注册管理技术体系，优化审评审批流程，提高审评审批能力，提升审评审批质量和效率。

第二十三条　医疗器械专业技术机构建立健全沟通交流制度，明确沟通交流的形式和内容，根据工作需要组织与申请人进行沟通交流。

第二十四条　医疗器械专业技术机构根据工作需要建立专家咨询制度，在审评、核查、检验等过程中就重大问题听取专家意见，充分发挥专家的技术支撑作用。

第三章　体外诊断试剂注册

第一节　产品研制

第二十五条　体外诊断试剂研制应当遵循风险管理原则，考虑现有公认技术水平，确保产品所有已知和可预见的风险以及非预期影响最小化并可接受，保证产品在正常使用中受益大于风险。

第二十六条　从事体外诊断试剂产品研制实验活动，应当符合我国相关法律、法规和强制性标准等的要求。

第二十七条　申请人、备案人应当编制申请注册或者进行备案体外诊断试剂的产品技术要求。

产品技术要求主要包括体外诊断试剂成品的可进行客观判定的功能性、安全性指标和检测方法。

第三类体外诊断试剂的产品技术要求中应当以附录形式明确主要原材料以及生产工艺要求。

体外诊断试剂应当符合经注册或者备案的产品技术要求。

第二十八条　申请人、备案人应当编制申请注册或者进行备案体外诊断试剂的产品说明书和标签。

产品说明书和标签应当符合《医疗器械监督管理条例》第三十九条要求以及相关规定。

第二十九条　体外诊断试剂研制，应当根据产品预期用途和技术特征开展体外诊断试剂非临床研究。

非临床研究指在实验室条件下对体外诊断试剂进行的试验或者评价，包括主要原材料的选择及制备、产品生产工艺、产品分析性能、阳性判断值或者参考区间、产品稳定性等的研究。

申请注册或者进行备案，应当提交研制活动中产生的非临床证据。

第三十条　体外诊断试剂非临床研究过程中确定的功能性、安全性指标及方法应当与产品预期使用条件、目的相适应，研究样品应当具有代表性和典型性。必要时，应当进行方法学验证、统计学分析。

第三十一条　申请注册或者进行备案，应当按照产品技术要求进行检验，并提交检验报告。检验合格的，方可开展临床试验或者申请注册、进行备案。

第三十二条　同一注册申请包括不同包装规格时，可以只进行一种包装规格产品的检验，检验用产品应当能够代表申请注册或者进行备案产品的安全性和有效性，其生产应当符合医疗器械生产质量管理规范的相关要求。

第三十三条　申请注册或者进行备案提交的检验报告可以是申请人、备案人的自检报告，也可以是委托有资质的医疗器械检验机构出具的检验报告。

第三类体外诊断试剂应当提供3个不同生产批次产品的检验报告。

第三十四条　对于有适用的国家标准品的，应当使用国家标准品对试剂进行检验。中国食品药品检定研究院负责组织国家标准品的制备和标定工作。

第二节　临床评价

第三十五条　体外诊断试剂临床评价是指采用科学合理的方法对临床数据进行分析、评价，对产品是否满足使用要求或者预期用途进行确认，以证明体外诊断试剂的安全性、有效性的过程。

第三十六条　体外诊断试剂临床试验是指在相应的临床环境中，对体外诊断试剂的临床性能进行的系统性研究。

国家药品监督管理局制定体外诊断试剂临床试验指南，明确开展临床试验的要求、临床试验报告的撰写要求等。

第三十七条　开展体外诊断试剂临床评价，应当进行临床试验证明体外诊断试剂的安全性、有效性。

符合如下情形的，可以免于进行临床试验：

（一）反应原理明确、设计定型、生产工艺成熟，已上市的同品种体外诊断试剂临床应用多年且无严重不良事件记录，不改变常规用途的；

（二）通过进行同品种方法学比对的方式能够证明该体外诊断试剂安全、有效的。

免于进行临床试验的第二类、第三类体外诊断试剂目录由国家药品监督管理局制定、调整并公布。

第三十八条　免于进行临床试验的体外诊断试剂，申请人应当通过对符合预期用途的临床样本进行同品种方法学比对的方式证明产品的安全性、有效性。

国家药品监督管理局制定免于进行临床试验的体外诊断试剂临床评价相关指南。

第三十九条　体外诊断试剂临床评价资料是指申请人进行临床评价所形成的文件。

开展临床试验的，临床试验资料包括临床试验方案、伦理委员会意见、知情同意书、临床试验报告以及相关数据等。

列入免于进行临床试验目录的体外诊断试剂，临床评价资料包括与同类已上市产品的对比分析、方法学比对数据、相关文献数据分析和经验数据分析等。

第四十条　同一注册申请包括不同包装规格时，可以只采用一种包装规格的产品进行临床评价，临床评价用产品应当代表申请注册或者进行备案产品的安全性和有效性。

校准品、质控品单独申请注册不需要提交临床评价资料。

第四十一条　开展体外诊断试剂临床试验，应当按照医疗器械临床试验质量管理规范的要求，在具备相应条件并按照规定备案的医疗器械临床试验机构内进行。临床试验开始前，临床试验申办者应当向所在地省、自治区、直辖市药品监督管理部门进行临床试验备案。临床试验体外诊断试剂的生产应当符合医疗器械生产质量管理规范的相关要求。

第四十二条　对于体外诊断试剂临床试验期间出现的临床试验体外诊断试剂相关严重不良事件，或者其他严重安全性风险信息，临床试验申办者应当按照相关要求，分别向所在地和临床试验机构所在地省、自治区、直辖市药品监督管理部门报告，并采取风险控制措施。未采取风险控制措施的，省、自治区、直辖市药品监督管理部门依法责令申办者采取相应的风险控制措施。

第四十三条　体外诊断试剂临床试验中出现大范围临床试验体外诊断试剂相关严重不良事件，或者其他重大安全性问题时，申办者应当暂停或者终止体外诊断试剂临床试验，分别向所在地和临床试验机构所在地省、自治区、直辖市药品监督管理部门报告。未暂停或者终止的，省、自治区、直辖市药品监督管理部门依法责令申办者采取相应的风险控制措施。

第四十四条　对预期供消费者个人自行使用的体外诊断试剂开展临床评价时，申请人还应当进行无医学背景的消费者对产品说明书认知能力的评价。

第四十五条　对正在开展临床试验的用于诊断严重危及生命且尚无有效诊断手段的疾病的体外诊断试剂，经医学观察可能使患者获益，经伦理审查、知情同意后，可以在开展体外诊断试剂的临床试验的机构内免费用于其他病情相同的患者，其安全性数据可以用于体外诊断试剂注册申请。

第三节　注册体系核查

第四十六条　申请人应当在申请注册时提交与产品研制、生产有关的质量管理体系相关资料，受理注册申请的药品监督管理部门在产品技术审评时认为有必要对质量管理体系进行核查的，应当组织开展质量管理体系核查，并可以根据需要调阅原始资料。

第四十七条　境内第三类体外诊断试剂质量管理体系核查，由国家局器械审评中心通知申请人所在地的省、自治区、直辖市药品监督管理部门开展。

境内第二类体外诊断试剂质量管理体系核查，由申请人所在地省、自治区、直辖市药品监督管理部门组织开展。

第四十八条　省、自治区、直辖市药品监督管理部门按照医疗器械生产质量管理规范的要求开展质量管理体系核查，重点对申请人是否按照医疗器械生产质量管理规范的要求建立与产品相适应的质量管理体系，以及与产品研制、生产有关的设计开发、生产管理、质量控制等内容进行核查。

在核查过程中，应当同时对检验用产品和临床试验产品的真实性进行核查，重点查阅设计开发过程相关记录，以及检验用产品和临床试验产品生产过程的相关记录。

提交自检报告的，应当对申请人、备案人或者受托机构研制过程中的检验能力、检验结果等进行重点核查。

第四十九条　省、自治区、直辖市药品监督管理部门可以通过资料审查或者现场检查的方式开展质量管理体系核查。根据申请人的具体情况、监督检查情况、本次申请注册产品与既往已通过核查产品生产条件及工艺对比情况等，确定是否现场检查以及检查内容，避免重复检查。

第五十条　国家局器械审评中心对进口第二类、第三类体外诊断试剂开展技术审评时，认为有必要进行质量管理体系核查的，通知国家局审核查验中心根据相关要求开展核查。

第四节　产品注册

第五十一条　申请人应当在完成支持体外诊断试剂注册的安全性、有效性研究，做好接受质量管理体系核查的准备后，提出体外诊断试剂注册申请，并按照相关要求，通过在线注册申请等途径向药品监督管理部门提交下列注册申请资料：

（一）产品风险分析资料；

（二）产品技术要求；

（三）产品检验报告；

（四）临床评价资料；

（五）产品说明书以及标签样稿；

（六）与产品研制、生产有关的质量管理体系文件；

（七）证明产品安全、有效所需的其他资料。

第五十二条　药品监督管理部门收到申请后对申请资料进行审核，并根据下列情况分别作出处理：

（一）申请事项属于本行政机关职权范围，申请资料齐全、符合形式审核要求的，予以受理；

（二）申请资料存在可以当场更正的错误的，应当允许申请人当场更正；

（三）申请资料不齐全或者不符合法定形式的，应当当场或者在5日内一次告知申请人需要补正的全部内容，逾期不告知的，自收到申请资料之日起即为受理；

（四）申请事项依法不属于本行政机关职权范围的，应当即时作出不予受理的决定，并告知申请人向有关行政机关申请。

药品监督管理部门受理或者不予受理体外诊断试剂注册申请，应当出具加盖本行政机关专用印章和注明日期的受理或者不予受理的通知书。

体外诊断试剂注册申请受理后，需要申请人缴纳费用的，申请人应当按规定缴纳费用。申请人未在规定期限内缴纳费用的，视为申请人主动撤回申请，药品监督管理部门终止其注册程序。

第五十三条　技术审评过程中需要申请人补正资料的，技术审评机构应当一次告知需要补正的全部内容。申请人应当在收到补正通知1年内，按照补正通知要求一次提供补充资料；技术审评机构收到补充资料后，在规定的时限内完成技术审评。

申请人对补正通知内容有异议的，可以向相应的技术审评机构提出书面意见，说明理由并提供相应的技术支持资料。

申请人逾期未提交补充资料的，终止技术审评，药品监督管理部门作出不予注册的决定。

第五十四条　对于已受理的注册申请，申请人可以在行政许可决定作出前，向受理该申请的药品监督管理部门申请撤回注册申请及相关资料，并说明理由。同意撤回申请的，药品监督管理部门终止其注册程序。

审评、核查、审批过程中发现涉嫌存在隐瞒真实情况或者提供虚假信息等违法行为的，依法处理，申请人不得撤回注册申请。

第五十五条　对于已受理的注册申请，有证据表明注册申请资料可能虚假的，药品监督管理部门可以中止审评审批。经核实后，根据核实结论继续审查或者作出不予注册的决定。

第五十六条　体外诊断试剂注册申请审评期间，对于拟作出不通过的审评结论的，技术审评机构应当告知申请人不通过的理由，申请人可以在15日内向技术审评机构提出异议，异议内容仅限于原申请事项和原申请资料。技术审评机构结合申请人的异议意见进行综合评估并反馈申请人。异议处理时间不计入审评时限。

第五十七条　受理注册申请的药品监督管理部门应当在技术审评结束后，作出是否批准的决定。对符合安全、有效、质量可控要求的，准予注册，发给医疗器械注册证，经过核准的产品技术要求和产品说明书以附件形式发给申请人。对不予注册的，应当书面说明理由，并同时告知申请人享有依法申请行政复议或者提起行政诉讼的权利。

医疗器械注册证有效期为5年。

第五十八条　对于已受理的注册申请，有下列情形之一的，药品监督管理部门作出不予注册的决定，并告知申请人：

（一）申请人对拟上市销售体外诊断试剂的安全性、有效性、质量可控性进行的研究及其结果无法证明产品安全、有效、质量可控的；

（二）质量管理体系核查不通过，以及申请人拒绝接受质量管理体系现场检查的；

（三）注册申请资料虚假的；

（四）注册申请资料内容混乱、矛盾，注册申请资料内容与申请项目明显不符，不能证明产品安全、有效、质量可控的；

（五）不予注册的其他情形。

第五十九条　法律、法规、规章规定实施行政许可应当听证的事项，或者药品监督管理部门认为需要听证的其他涉及公共利益的重大行政许可事项，药品监督管理部门应当向社会公告，并举行听证。医疗器械注册申请直接涉及申请人与他人之间重大利益关系的，药品监督管理部门在作出行政许可决定前，应当告知申请人、利害关系人享有要求听证的权利。

第六十条　对用于罕见疾病、严重危及生命且尚无有效诊断手段的疾病和应对公共卫生事件等急需的体外诊断试剂，药品监督管理部门可以作出附条件批准决定，并在医疗器械注册证中载明有效期、上市后需要继续完成的研究工作及完成时限等相关事项。

第六十一条　对附条件批准的体外诊断试剂，注册人应当在体外诊断试剂上市后收集受益和风险相关数据，持续对产品的受益和风险开展监测与评估，采取有效措施主动管控风险，并在规定期限内按照要求完成研究并提交相关资料。

第六十二条　对附条件批准的体外诊断试剂，注册人逾期未按照要求完成研究或者不能证明其受益大于风险的，注册人应当及时申请办理医疗器械注册证注销手续，药品监督管理部门可以依法注销医疗器械注册证。

第六十三条　对新研制的尚未列入体外诊断试剂分类目录的体外诊断试剂，申请人可以直接申请第三类体外诊断试剂产品注册，也可以依据分类规则判断产品类别并向国家药品监督管理局申请类别确认后，申请产品注册或者进行产品备案。

直接申请第三类体外诊断试剂注册的，国家药品监督管理局按照风险程度确定类别。境内体外诊断试剂确定为第二类或者第一类的，应当告知申请人向相应的药品监督管理部门申请注册或者进行备案。

第六十四条　已注册的体外诊断试剂，其管理类别由高类别调整为低类别的，医疗器械注册证在有效期内继续有效。有效期届满需要延续的，注册人应当在医疗器械注册证有效期届满6个月前，按照调整后的类别向相应的药品监督管理部门申请延续注册或者进行备案。

体外诊断试剂管理类别由低类别调整为高类别的，注册人应当按照改变后的类别向相应的药品监督管理部门申请注册。国家药品监督管理局在管理类别调整通知中应当对完成调整的时限作出规定。

第六十五条　医疗器械注册证及其附件遗失、损毁的，注册人应当向原发证机关申请补发，原发证机关核实后予以补发。

第六十六条　注册申请审查过程中及批准后发生专利权纠纷的，应当按照有关法律、法规的规定处理。

第四章　特殊注册程序

第一节　创新产品注册程序

第六十七条　符合下列要求的体外诊断试剂，申请人可以申请适用创新产品注册程序：

（一）申请人通过其主导的技术创新活动，在中国依法拥有产品核心技术发明专利权，或者依法通过受让取得在中国发明专利权或其使用权，且申请适用创新产品注册程序的时间在专利授权公告日起5年内；或者核心技术发明专利的申请已由国务院专利行政部门公开，并由国家知识产权局专利检索咨询中心出具检索报告，载明产品核心技术方案具备新颖性和创造性；

（二）申请人已完成产品的前期研究并具有基本定型产品，研究过程真实和受控，研究数据完整和可溯源；

（三）产品主要工作原理或者作用机理为国内首创，产品性能或者安全性与同类产品比较有根本性改进，技术上处于国际领先水平，且具有显著的临床应用价值。

第六十八条　申请适用创新产品注册程序的，申请人应当在产品基本定型后，向国家药品监督管理局提出创新医疗器械审查申请。国家药品监督管理局组织专家进行审查，符合要求的，纳入创新产品注册程序。

第六十九条　对于适用创新产品注册程序的体外诊断试剂注册申请，国家药品监督管理局以及承担相关技术工作的机构，根据各自职责指定专人负责，及时沟通，提供指导。

纳入创新产品注册程序的体外诊断试剂，国家局器械审评中心可与申请人在注册申请受理前以及技术审评过程中就产品研制中的重大技术问题、重大安全性问题、临床试验方案、阶段性临床试验结果的总结与评价等问题沟通交流。

第七十条　纳入创新产品注册程序的体外诊断试剂，申请人主动要求终止或者国家药品监督管理局发现不再符合创新产品注册程序要求的，国家药品监督管理局可终止相关产品的创新产品注册程序并告知申请人。

第七十一条　纳入创新产品注册程序的体外诊断试剂，申请人在规定期限内未提出注册申请的，不再适用创新产品注册程序。

第二节　优先注册程序

第七十二条　满足下列情形之一的体外诊断试剂，可以申请适用优先注册程序：

（一）诊断罕见病、恶性肿瘤，且具有明显临床优势，诊断老年人特有和多发疾病且目前尚无有效诊断手段，专用于儿童且具有明显临床优势，或者临床急需且在我国尚无同品种产品获准注册的医疗器械；

（二）列入国家科技重大专项或者国家重点研发计划的医疗器械；

（三）国家药品监督管理局规定的其他可以适用优先注册程序的医疗器械。

第七十三条　申请适用优先注册程序的，申请人应当在提出体外诊断试剂注册申请时，向国家药品监督管理局提出适用优先注册程序的申请。属于第七十二条第一项情形的，由国家药品监督管理局组织专家进行审核，符合的，纳入优先注册程序；属于第七十二条第二项情形的，由国家局器械审评中心进行审核，符合的，纳入优先注册程序；属于第七十二条第三项情形的，由国家药品监督管理局广泛听取意见，并组织专家论证后确定是否纳入优先注册程序。

第七十四条　对纳入优先注册程序的体外诊断试剂注册申请，国家药品监督管理局优先进行审评审批，省、自治区、直辖市药品监督管理部门优先安排注册质量管理体系核查。

国家局器械审评中心在对纳入优先注册程序的医疗器械产品开展技术审评过程中，应当按照相关规定积极与申请人进行沟通交流，必要时，可以安排专项交流。

第三节　应急注册程序

第七十五条　国家药品监督管理局可以依法对突发公共卫生事件应急所需且在我国境内尚无同类产品上市，或者虽在我国境内已有同类产品上市但产品供应不能满足突发公共卫生事件应急处理需要的体外诊断试剂实施应急注册。

第七十六条　申请适用应急注册程序的，申请人应当向国家药品监督管理局提出应急注册申请。符合条件的，纳入应急注册程序。

第七十七条　对实施应急注册的体外诊断试剂注册申请，国家药品监督管理局按照统一指挥、早期介入、随到随审、科学审批的要求办理，并行开展体外诊断试剂产品检验、体系核查、技术审评等工作。

第五章　变更注册与延续注册

第一节　变更注册

第七十八条　注册人应当主动开展体外诊断试剂上市后研究，对体外诊断试剂的安全性、有效性和质量可控性进行进一步确认，加强对已上市体外诊断试剂的持续管理。

已注册的第二类、第三类体外诊断试剂产品，其设计、原材料、生产工艺、适用范围、使用方法等发生实质性变化，有可能影响该体外诊断试剂安全、有效的，注册人应当向原注册部门申请办理变更注册手续；发生其他变化的，应当在变化之日起30日内向原注册部门备案。

注册证载明的产品名称、包装规格、主要组成成分、预期用途、产品技术要求、产品说明书、进口体外诊断试剂的生产地址等，属于前款规定的需要办理变更注册的事项。注册人名称和住所、代理人名称和住所等，属于前款规定的需要备案的事项。境内体外诊断试剂生产地址变更的，注册人应当在办理相应的生产许可变更后办理备案。

发生其他变化的，注册人应当按照质量管理体系要求做好相关工作，并按照规定向药品监督管理部门报告。

第七十九条　已注册的第二类、第三类体外诊断试剂，产品的核心技术原理等发生实质性改变，或者发生其他重大改变、对产品安全有效性产生重大影响，实质上构成新的产品的，不属于本章规定的变更申请事项，应当按照注册申请的规定办理。

第八十条　对于变更注册申请，技术审评机构应当重点针对变化部分进行审评，对变化后产品是否安全、有效、质量可控形成审评意见。

在对变更注册申请进行技术审评时，认为有必要对质量管理体系进行核查的，药品监督管理部门应当组织开展质量管理体系核查。

第八十一条　医疗器械变更注册文件与原医疗器械注册证合并使用，有效期截止日期与原医疗器械注册证相同。

第二节　延续注册

第八十二条　医疗器械注册证有效期届满需要延续注册的，注册人应当在医疗器械注册证有效期届满6个月前，向原注册部门申请延续注册，并按照相关要求提交申请资料。

除有本办法第八十三条规定情形外，接到延续注册申请的药品监督管理部门应当在医疗器械注册证有效期届满前作出准予延续的决定。逾期未作决定的，视为准予延续。

第八十三条　有下列情形之一的，不予延续注册：

（一）未在规定期限内提出延续注册申请；

（二）新的体外诊断试剂强制性标准或者国家标准品发布实施，申请延续注册的体外诊断试剂不能达到新要求；

（三）附条件批准的体外诊断试剂，未在规定期限内完成医疗器械注册证载明事项。

第八十四条　延续注册的批准时间在原注册证有效期内的，延续注册的注册证有效期起始日为原注册证到期日次日；批准时间不在原注册证有效期内的，延续注册的注册证有效期起始日为批准延续注册的日期。

第八十五条　体外诊断试剂变更注册申请、延续注册申请的受理与审批程序，本章未作规定的，适用本办法第三章的相关规定。

第六章　体外诊断试剂备案

第八十六条　第一类体外诊断试剂生产前，应当进行产品备案。

第八十七条　进行体外诊断试剂备案，备案人应当按照《医疗器械监督管理条例》的规定向药品监督管理部门提交备案资料，获取备案编号。

第八十八条　已备案的体外诊断试剂，备案信息表中登载内容及备案的产品技术要求发生变化的，备案人应当向原备案部门变更备案，并提交变化情况的说明以及相关文件。药品监督管理部门应当将变更情况登载于备案信息中。

第八十九条　已备案的体外诊断试剂管理类别调整为第二类或者第三类体外诊断试剂的，应当按照本办法规定申请注册。

第七章　工作时限

第九十条　本办法所规定的时限是体外诊断试剂注册的受理、技术审评、核查、审批等工作的最长时间。特殊注册程序相关工作时限，按特殊注册程序相关规定执行。

国家局器械审评中心等专业技术机构应当明确本单位工作程序和时限，并向社会公布。

第九十一条　药品监督管理部门收到体外诊断试剂注册申请后，应当自受理之日起3日内将申请资料转交技术审评机构。

第九十二条　体外诊断试剂注册技术审评时限，按照以下规定执行：

（一）第二类体外诊断试剂注册申请、变更注册申请、延续注册申请的技术审评时限为60日，申请资料补正后的技术审评时限为60日；

（二）第三类体外诊断试剂注册申请、变更注册申请、延续注册申请的技术审评时限为90日，申请资料补正后的技术审评时限为60日。

第九十三条　境内第三类体外诊断试剂质量管理体系核查时限，按照以下规定执行：

（一）国家局器械审评中心应当在体外诊断试剂注册申请受理后10日内通知相关省、自治区、直辖市药品监督管理部门启动核查；

（二）省、自治区、直辖市药品监督管理部门原则上在接到核查通知后30日内完成核查，并将核查情况、核查结果等相关材料反馈至国家局器械审评中心。

第九十四条　受理注册申请的药品监督管理部门应当自收到审评意见之日起20日内作出决定。

第九十五条　药品监督管理部门应当自作出体外诊断试剂注册审批决定之日起10日内颁发、送达有关行政许可证件。

第九十六条　因产品特性以及技术审评、核查等工作遇到特殊情况确需延长时限的，延长时限不得超过原时限的二分之一，经医疗器械技术审评、核查等相关技术机构负责人批准后，由延长时限的技术机构书面告知申请人，并通知其他相关技术机构。

第九十七条　原发证机关应当自收到医疗器械注册证补办申请之日起20日内予以补发。

第九十八条　以下时间不计入相关工作时限：

（一）申请人补充资料、核查后整改等所占用的时间；

（二）因申请人原因延迟核查的时间；

（三）外聘专家咨询、召开专家咨询会、需要与药品审评机构联合审评的时间；

（四）根据规定中止审评审批程序的，中止审评审批程序期间所占用的时间；

（五）质量管理体系核查所占用的时间。

第九十九条　本办法规定的时限以工作日计算。

第八章　监督管理

第一百条　药品监督管理部门应当加强体外诊断试剂研制活动的监督检查，必要时可以对为体外诊断试剂研制提供产品或者服务的单位和个人进行延伸检查，有关单位和个人应当予以配合，提供相关文件和资料，不得拒绝、隐瞒、阻挠。

第一百零一条　国家药品监督管理局建立并分步实施医疗器械唯一标识制度，申请人、备案人应当按照相关规定提交唯一标识相关信息，保证数据真实、准确、可溯源。

第一百零二条　国家药品监督管理局应当及时将代理人信息通报代理人所在地省、自治区、直辖市药品监督管理部门。省、自治区、直辖市药品监督管理部门对本行政区域内的代理人组织开展日常监督管理。

第一百零三条　省、自治区、直辖市药品监督管理部门根据医疗器械临床试验机构备案情况，组织对本行政区域内已经备案的临床试验机构开展备案后监督检查。对于新备案的医疗器械临床试验机构，应当在备案后60日内开展监督检查。

省、自治区、直辖市药品监督管理部门应当组织对本行政区域内医疗器械临床试验机构遵守医疗器械临床试验质量管理规范的情况进行日常监督检查，监督其持续符合规定要求。国家药品监督管理局根据需要对医疗器械临床试验机构进行监督检查。

第一百零四条　药品监督管理部门认为有必要的，可以对临床试验的真实性、准确性、完整性、规范性和可追溯性进行现场检查。

第一百零五条　承担第一类体外诊断试剂产品备案工作的药品监督管理部门在备案后监督中，发现备案资料不规范的，应当责令备案人限期改正。

第一百零六条　药品监督管理部门未及时发现本行政区域内体外诊断试剂注册管理系统性、区域性风险，或者未及时消除本行政区域内体外诊断试剂注册管理系统性、区域性隐患的，上级药品监督管理部门可以对下级药品监督管理部门主要负责人进行约谈。

第九章　法律责任

第一百零七条　违反本办法第七十八条的规定，未按照要求对发生变化进行备案的，责令限期改正；逾期不改正的，处1万元以上3万元以下罚款。

第一百零八条　开展体外诊断试剂临床试验未遵守临床试验质量管理规范的，依照《医疗器械监督管理条例》第九十四条予以处罚。

第一百零九条　医疗器械技术审评机构未依照本办法规定履行职责，致使审评工作出现重大失误的，由负责药品监督管理的部门责令改正，通报批评，给予警告；造成严重后果的，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，依法给予处分。

第一百一十条　负责药品监督管理的部门工作人员违反规定，滥用职权、玩忽职守、徇私舞弊的，依法给予处分。

第十章　附　　则

第一百一十一条　体外诊断试剂的命名应当遵循以下原则：

体外诊断试剂的产品名称一般由三部分组成。第一部分：被测物质的名称；第二部分：用途，如测定试剂盒、质控品等；第三部分：方法或者原理，如磁微粒化学发光免疫分析法、荧光PCR法、荧光原位杂交法等，本部分应当在括号中列出。

如果被测物组分较多或者有其他特殊情况，可以采用与产品相关的适应症名称或者其他替代名称。

第一类产品和校准品、质控品，依据其预期用途进行命名。

第一百一十二条　体外诊断试剂的注册或者备案单元应为单一试剂或者单一试剂盒，一个注册或者备案单元可以包括不同的包装规格。

校准品、质控品可以与配合使用的体外诊断试剂合并申请注册，也可以单独申请注册。

第一百一十三条　获准注册的体外诊断试剂，是指与该医疗器械注册证及附件限定内容一致且在医疗器械注册证有效期内生产的体外诊断试剂。

第一百一十四条　医疗器械注册证中“主要组成成分”栏内所载明的独立试剂组分，用于原注册产品的，可以单独销售。

第一百一十五条　申请人在申请体外诊断试剂产品注册、变更注册中可以经医疗器械主文档所有者授权，引用经登记的医疗器械主文档。医疗器械主文档由其所有者或代理机构办理登记，相关工作程序另行规定。

第一百一十六条　医疗器械注册证格式由国家药品监督管理局统一制定。

注册证编号的编排方式为：

×1械注×2××××3×4××5××××6。其中：

×1为注册审批部门所在地的简称：

境内第三类体外诊断试剂、进口第二类、第三类体外诊断试剂为“国”字；

境内第二类体外诊断试剂为注册审批部门所在地省、自治区、直辖市简称；

×2为注册形式：

“准”字适用于境内体外诊断试剂；

“进”字适用于进口体外诊断试剂；

“许”字适用于香港、澳门、台湾地区的体外诊断试剂；

××××3为首次注册年份；

×4为产品管理类别；

××5为产品分类编码；

××××6为首次注册流水号。

延续注册的，××××3和××××6数字不变。产品管理类别调整的，应当重新编号。

第一百一十七条　第一类医疗器械备案编号的编排方式为：

×1械备××××2××××3。其中：

×1为备案部门所在地的简称：

进口第一类体外诊断试剂为“国”字；

境内第一类体外诊断试剂为备案部门所在地省、自治区、直辖市简称加所在地设区的市级行政区域的简称（无相应设区的市级行政区域时，仅为省、自治区、直辖市的简称）；

××××2为备案年份；

××××3为备案流水号。

第一百一十八条　药品监督管理部门制作的医疗器械注册证、变更注册文件电子文件与纸质文件具有同等法律效力。

第一百一十九条　根据工作需要，国家药品监督管理局可以依法委托省、自治区、直辖市药品监督管理部门或者技术机构、社会组织承担有关的具体工作。

第一百二十条　省、自治区、直辖市药品监督管理部门可以参照本办法第四章规定制定本行政区域内第二类体外诊断试剂特殊注册程序，并报国家药品监督管理局备案。

第一百二十一条　体外诊断试剂产品注册收费项目、收费标准按照国务院财政、价格主管部门的有关规定执行。

第一百二十二条　体外诊断试剂紧急使用的有关规定，由国家药品监督管理局会同有关部门另行制定。

第一百二十三条　国内尚无同品种产品上市，医疗机构根据本单位的临床需要自行研制，在执业医师指导下在本单位内使用的体外诊断试剂，相关管理规定由国家药品监督管理局会同有关部门另行制定。

第一百二十四条　香港、澳门、台湾地区体外诊断试剂的注册、备案，参照进口体外诊断试剂办理。

第一百二十五条　本办法自2021年10月1日起施行。2014年7月30日原国家食品药品监督管理总局令第5号公布的《体外诊断试剂注册管理办法》同时废止。