Order of the State Administration for Market Regulation
No. 47
The "Administrative Measures for Registration and Filing of Medical Devices", 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
Administrative Measures for Registration and Filing of Medical Devices
Chapter 1 General Provisions
Article 1 In order to regulate the registration and filing of medical devices and ensure the safety, effectiveness and quality control of medical devices, 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 medical devices within the territory of the People's Republic of China.
Article 3 Medical device registration means that an applicant for medical device registration (hereinafter referred to as the applicant) submits an application for medical device registration in accordance with legal procedures and requirements. Quality controllability and other reviews to decide whether to agree to the activities of its application.
Medical device filing refers to the activity that the medical device filing person (hereinafter referred to as the filing person) submits filing materials to the drug regulatory department in accordance with legal procedures and requirements, and the drug regulatory department archives the submitted filing materials for future reference.
Article 4 The State Drug Administration is in charge of the national medical device registration and filing management work, is responsible for establishing the medical device registration and filing management system and system, and organizes the review of domestic third-class and imported second-class and third-class medical devices in accordance with the law Approval, filing of imported Class I medical devices and related supervision and management, and supervising and guiding local medical device registration and filing.
Article 5 The Medical Device Technology Evaluation Center of the State Drug Administration (hereinafter referred to as the National Bureau of Device Evaluation Center) is responsible for the clinical trial applications for medical devices that require clinical trial approval, as well as domestic Class III and imported Class II and Class III applications. Technical review of medical device product registration applications, registration modification applications, and registration renewal applications.
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 undertake the medical device standard management, classification definition, inspection, verification, monitoring and evaluation required for the implementation of medical device supervision and management according to their duties. , certificate delivery and the corresponding information construction and management and other related work.
Article 6 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the administration of the following medical device registrations within their respective administrative regions:
(1) Review and approval of domestic Class II medical device registration;
(2) Inspection of the quality management system of domestic Class II and Class III medical devices;
(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 Class I medical devices in the department responsible for drug supervision and administration at the city level with districts.
The professional 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 technical review, inspection, verification, monitoring and evaluation required for the implementation of medical device supervision and management .
The department in charge of drug supervision and administration at the city level with districts shall be responsible for the filing management of Class I medical device products within the country.
Article 7 The management of medical device registration and filing shall follow the principles of lawfulness, science, openness, fairness and impartiality.
Article 8 The first-class medical devices are subject to product filing management. Class II and Class III medical devices are subject to product registration management.
For domestic first-class medical device filing, the filing person submits materials to the department responsible for drug supervision and administration at the city level with districts.
Domestic Class II medical devices 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.
Domestic Class III medical devices are reviewed by the State Drug Administration, and a medical device registration certificate is issued after approval.
For the filing of imported Class I medical devices, the filing person submits filing materials to the State Drug Administration.
The import of Class II and Class III medical devices shall be reviewed by the State Drug Administration, and a medical device registration certificate shall be issued after approval.
Article 9 Medical device registrants and filers shall strengthen the quality management of the whole life cycle of medical devices, and assume responsibility for the safety, effectiveness and quality controllability of medical devices in the whole process of development, production, operation and use.
Article 10 The State Drug Administration shall give priority to the examination and approval of medical devices urgently needed in the clinic, and implement special examination and approval for innovative medical devices, encourage the research and innovation of medical devices, and promote the high-quality development of the medical device industry.
Article 11 The State Drug Administration shall establish and improve medical device standards, technical guidelines and other systems in accordance with the law, standardize medical device technical review and quality management system verification, and guide and serve medical device research and development and registration applications.
Article 12 The drug regulatory department shall disclose the relevant information of medical device registration and filing 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 13 The registration and filing of medical devices shall comply with relevant laws, regulations, rules, and mandatory standards, follow the basic principles of medical device safety and performance, and refer to relevant technical guidelines to prove that the registered and filed medical devices are safe, effective, and of acceptable quality. To ensure the authenticity, accuracy, completeness and traceability of the whole process information.
Article 14 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 relevant medical device registration and filing matters. 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 15 The applicant and filing party shall establish a quality management system suitable for the product and keep it in effective operation.
Article 16 Personnel handling medical device registration and filing matters shall have corresponding professional knowledge and be familiar with the laws, regulations, rules and relevant provisions on registration management of medical device registration and filing management.
Article 17 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 18 To apply for the registration of imported medical devices and to handle the filing of imported medical devices, 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 of the medical device.
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.
Innovative medical devices that are not listed in the country (region) where the applicant or filer is registered or where the production is located do not need to submit relevant documents.
Article 19 Medical devices shall comply with applicable mandatory standards. If the product structure characteristics, intended use, usage, etc. 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 20 The registration and filing of medical devices shall follow the relevant requirements of medical device classification rules and classification catalogs.
Article 21 The drug regulatory authorities continue to promote the reform of the review and approval system, strengthen the scientific research on the supervision of medical devices, and establish a medical device registration management technology system that is dominated by technical review and supported by verification, inspection, monitoring and evaluation, etc. Optimize the review and approval process, improve review and approval capabilities, and improve the quality and efficiency of review and approval.
Article 22 Medical device professional and 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 23 Medical device professional 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 III Medical Device Registration
Section 1 Product Development
Article 24 The development of medical devices 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 outweigh the risks .
Article 25 Those engaged in the research and development and experimental activities of medical device products shall comply with the requirements of relevant laws, regulations and mandatory standards of China.
Article 26 The applicant and filing party shall formulate product technical requirements for medical devices applying for registration or filing.
Product technical requirements mainly include functional, safety indicators and testing methods of finished medical devices that can be objectively judged.
Medical devices shall meet the technical requirements for registered or filed products.
Article 27 Applicants and recorders shall prepare product instructions and labels of medical devices for registration or recordation.
Product instructions and labels shall comply with Article 39 of the Regulations on the Supervision and Administration of Medical Devices and relevant regulations.
Article 28 For the research and development of medical devices, non-clinical research on medical devices shall be carried out according to the scope of application and technical characteristics of the products.
Non-clinical research includes research on chemical and physical properties of products, electrical safety research, radiation safety research, software research, biological characteristics research, biological source material safety research, disinfection and sterilization process research, animal test research, stability research, etc.
When applying for registration or filing, the non-clinical evidence generated in the research and development activities, including the summary of non-clinical research reports, research protocols and research reports shall be submitted.
Article 29 The functional and safety indicators and methods determined in the non-clinical research process of medical devices 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 30 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 31 The product for inspection shall be able to represent the safety and effectiveness of the product applied for registration or filing, and its production shall comply with the relevant requirements of the medical device production quality management standard.
Article 32 The medical device product inspection report submitted for registration or filing can be the self-inspection report of the applicant or the filing party, or the inspection report issued by a qualified medical device inspection agency.
The second clinical evaluation
Article 33 Except for the situations specified in Article 34 of these Measures, the registration and filing of medical device products shall be subject to clinical evaluation.
Clinical evaluation of medical devices refers to the activities of using scientific and reasonable methods to analyze and evaluate clinical data to confirm the safety and effectiveness of medical devices within their applicable scope.
To apply for medical device registration, clinical evaluation materials shall be submitted.
Article 34 Under any of the following circumstances, the clinical evaluation may be exempted:
(1) The working mechanism is clear, the design is finalized, the production process is mature, and the same variety of medical devices 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) Others that can prove that the medical device is safe and effective through non-clinical evaluation.
Those exempted from clinical evaluation may be exempted from submitting clinical evaluation materials.
The list of medical devices exempted from clinical evaluation shall be formulated, adjusted and published by the State Drug Administration.
Article 35 To carry out clinical evaluation of medical devices, it is possible to conduct clinical trials according to product characteristics, clinical risks, existing clinical data, etc. Safety and efficacy of the device.
According to the regulations of the State Drug Administration, when clinical evaluation of medical devices is carried out, if the existing clinical literature and clinical data are insufficient to confirm the safety and effectiveness of the products, clinical trials should be carried out.
The State Drug Administration has formulated guidelines for clinical evaluation of medical devices, specifying the requirements for clinical evaluation through clinical literature and clinical data of the same variety of medical devices, the circumstances under which clinical trials are required, and the requirements for writing clinical evaluation reports.
Article 36 If the clinical evaluation is conducted through the clinical literature and clinical data of the same variety of medical devices, the clinical evaluation data includes the comparison between the registered product and the same variety of medical devices, the analysis and evaluation of the clinical data of the same variety of medical devices, and the comparison of the registered product and the same variety of medical devices. Scientific evidence and evaluation conclusions when there are differences between products of the same variety.
If clinical evaluation is carried out through clinical trials, the clinical evaluation materials include clinical trial protocols, ethics committee opinions, informed consent, and clinical trial reports.
Article 37 Clinical trials of medical devices shall be carried out 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 clinical trial medical devices shall comply with the relevant requirements of the Good Manufacturing Practice for Medical Devices.
Article 38 Where clinical trials of Class III medical devices have relatively high risks to the human body, they shall be approved by the State Drug Administration.
Clinical trial approval means that the State Drug Administration conducts a comprehensive analysis of the risk level, clinical trial protocol, clinical benefit and risk comparative analysis report, etc. process of testing.
The catalogue of Class III medical devices subject to clinical trial approval shall be formulated, adjusted and published by the State Drug Administration. Clinical trials of Class III medical devices that require clinical trial approval shall be carried out in Class III A medical institutions that meet the requirements.
Article 39 For medical device clinical trial approval, the applicant shall submit application materials such as summary materials, research materials, clinical materials, product instructions and label samples in accordance with relevant requirements.
Article 40 The device review center of the State Administration shall review the accepted clinical trial applications. For the clinical trial application, a decision on whether or not to agree shall be made within 60 days from the date of acceptance of the application, and the applicant shall be notified through the website of the National Bureau of Device Evaluation Center. Failure to notify within the time limit shall be deemed consent.
Article 41 If the applicant needs to supplement and correct materials during the review process, the Center for Device Review of the State Administration shall notify all the contents that need to be supplemented and corrected at one time. The applicant shall, within 1 year of receiving the notice of supplement and correction, provide supplementary materials once in accordance with the requirements of the notice of supplement and correction. After receiving the supplementary materials, the National Bureau of Device Evaluation Center will complete the technical evaluation according to the prescribed time limit.
If the applicant has any objection to the content of the supplementary notice, he may submit a written opinion to the Center for Device Evaluation of the State Administration, explaining the reasons and providing corresponding technical support materials.
If the applicant fails to submit supplementary materials within the time limit, the technical review shall be terminated and a decision of disapproval shall be made.
Article 42 For serious adverse events related to clinical trial medical devices or other serious safety risk information that occur during the clinical trial of medical devices, the clinical trial sponsor shall, in accordance with relevant requirements, report to the province or autonomous region where the clinical trial institution is located, respectively. , the municipal drug supervision and administration department report, 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 a large-scale clinical trial medical device or other major safety problems occur in the clinical trial of medical devices, the sponsor shall suspend or terminate the clinical trial of medical devices, and report to the locality and the province where the clinical trial institution is located respectively. , autonomous regions and municipalities directly under the Central Government drug supervision and administration departments report. 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 For an approved clinical trial, under any of the following circumstances, the State Drug Administration may order the applicant to terminate the clinical trial of medical devices that has been carried out:
(1) The application materials for clinical trials are false;
(2) The latest research has confirmed that there are ethical and scientific problems in the originally approved clinical trial;
(3) Other circumstances that should be terminated.
Article 45 The clinical trial of medical devices shall be carried out within 3 years after the approval; if the application for clinical trials of medical devices has not been signed by the subjects within 3 years from the date of approval, the license for clinical trials of medical devices shall be automatically invalidated. If a clinical trial is still required, a new application shall be applied.
Article 46 For medical devices that are undergoing clinical trials for the treatment of serious life-threatening diseases for which there is no effective treatment, the medical observation may benefit the patient. After ethical review and informed consent, the medical device may be The device clinical trial institutions are free for other patients with the same condition, and their safety data can be used for medical device registration applications.
Section 3 Registration System Verification
Article 47 The applicant shall submit relevant materials of the quality management system related to product development and production when applying for registration. The drug regulatory department that accepts the registration application considers 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 may refer to the original data as needed.
Article 48 The inspection of the quality management system of domestic Class III medical devices shall be carried out by the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the applicant is located by the National Bureau of Device Evaluation Center.
The inspection of the quality management system of domestic Class II medical devices 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 49 The drug supervision and administration departments of 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 50 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 51 When conducting technical review on imported Class II and Class III medical devices, the National Bureau of Device Evaluation Center shall notify the National Bureau of Inspection and Inspection Center to carry out inspections according to relevant requirements.
Section 4 Product Registration
Article 52 The applicant shall submit an application for medical device registration after completing the safety and effectiveness research to support the registration of medical devices and prepare for the inspection of the quality management system, and in accordance with relevant requirements, through online registration applications and other channels Submit the following registration application materials to the drug regulatory authority:
(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 53 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 medical device registration, it shall issue a notice of acceptance or rejection affixed with the special seal of the administrative organ and dated.
After the application for medical device registration 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 54 If the applicant needs to supplement and correct materials during the technical review process, the technical review agency shall notify 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 55 For a registration application that has been accepted, the applicant may apply to the drug regulatory department that accepted the application for withdrawal of the registration application and related materials, and explain the reasons before the administrative licensing decision is made. 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 application for medical device registration.
Article 56 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 57 During the review of the medical device registration application, 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 file an objection to the technical review agency within 15 days , the objection content 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 58 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 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 59 For an accepted registration application, in any of the following circumstances, the drug regulatory department shall make a decision not to register and notify the applicant:
(1) The applicant's research on the safety, effectiveness and quality controllability of the medical device to be marketed and the results thereof cannot prove that the product is 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 60 For the matters that laws, regulations and rules stipulate that the implementation of administrative licensing should be heard, or other major administrative licensing matters involving public interests that the drug supervision and administration department deems necessary to hear, the drug supervision and administration 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 61 For medical devices that are urgently needed for the treatment of rare diseases, serious life-threatening diseases for which there is no effective treatment, and to respond to public health events, the drug regulatory department may make a conditional approval decision and register with the medical device The certificate specifies the validity period, the research work that needs to be completed after the listing, and the completion time limit and other related matters.
Article 62 For medical devices approved with conditions, the registrant shall collect data on benefits and risks after the medical devices are listed, continuously monitor and evaluate the benefits and risks of the products, take effective measures to actively control risks, and make sure that the medical devices are regulated. Complete the research and submit relevant materials as required within the time limit.
Article 63 For medical devices approved with conditions, 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 cancel it according to law. Medical device registration certificate.
Article 64 For newly developed medical devices that have not been included in the classification catalogue, the applicant can directly apply for the registration of the third-class medical device product, or can judge the product category according to the classification rules and apply for category confirmation to the State Drug Administration. , apply for product registration or carry out product filing.
For direct application for the registration of Class III medical devices, the State Drug Administration shall determine the class according to the degree of risk. If a domestic medical device is 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 65 For a registered medical device whose management category is adjusted from a high category to a low category, the medical device registration certificate will continue to be valid within the validity period. If the validity period needs to be renewed, it shall apply to the corresponding drug regulatory department 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 medical device management category 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 66 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 67 Where a patent right 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 68 For medical devices 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 69 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 70 For medical device registration applications that are subject to innovative product registration procedures, 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 medical devices included in the innovative product registration process, the National Bureau of Device Evaluation Center can discuss with the applicant about major technical issues, major safety issues, clinical trial plans, phased Communicate and communicate on the summary and evaluation of clinical trial results.
Article 71 If the applicant voluntarily requests termination of a medical device 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 terminates the innovative product registration process for the relevant product and Notify the applicant.
Article 72 For medical devices 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 73 Medical devices that meet one of the following conditions may apply for the priority registration procedure:
(1) Diagnose or treat rare diseases and malignant tumors with obvious clinical advantages, diagnose or treat diseases unique to the elderly and frequently-occurring diseases for which there is currently no effective diagnosis or treatment method, are dedicated to children and have obvious clinical advantages, or are urgently needed and in There is no medical device approved for registration of the same variety of products in my country;
(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 74 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 medical device registration. If it falls under the first item of Article 73, the State Drug Administration will organize experts to review it, and if it meets the requirements, it will be included in the priority registration procedure; if it falls under the second item of Article 73, it will be reviewed by the National Bureau of Device Evaluation Center. After review, those that meet the requirements will be included in the priority registration process; if it falls under the third circumstance of Article 73, the State Drug Administration will listen to opinions widely, and organize experts to determine whether to include it in the priority registration process after argumentation.
Article 75 For medical device registration applications that are included in the priority registration process, the State Drug Administration shall give priority to review and approval, and the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government shall give priority to the inspection of the medical device 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 76 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 but the supply of products cannot meet the requirements of public health emergencies. Emergency registration of medical devices required for emergency handling of incidents.
Article 77 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 78 For the medical device registration application for emergency registration, the State Drug Administration shall handle it in accordance with the requirements of unified command, early intervention, follow-up review, and scientific approval, and carry out medical device product inspection, system verification, and technical review in parallel. rating work.
Chapter 5 Change of Registration and Renewal of Registration
Section 1 Change of Registration
Article 79 The registrant shall take the initiative to conduct post-marketing research on medical devices, further confirm the safety, effectiveness and quality controllability of medical devices, and strengthen the continuous management of marketed medical devices.
For registered Class II and Class III medical device products, the design, raw materials, production process, scope of application, use method, etc. have undergone substantial changes, which may affect the safety and effectiveness of the medical device, the registrant shall report to the original registration department. Apply for changing the registration formalities; if other changes occur, it shall be filed with the original registration department within 30 days from the date of the change.
The product name, model, specification, structure and composition, scope of application, product technical requirements, and production address of imported medical devices, etc., as stated in the registration certificate, belong to the matters that need to be changed and registered as prescribed 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 medical devices is changed, the registrant shall go through the filing process 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 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 medical devices are issued and implemented, and the medical devices applying for renewal of registration cannot meet the new requirements;
(3) For medical devices 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 approval procedures of medical device registration modification 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 Medical Device Filing
Article 86 Before the production of Class I medical devices, product filing shall be carried out.
Article 87 For medical device filing, the filing person shall submit 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 For a medical device that has been filed, if the contents of the filing information form and the technical requirements of the filed product change, the filing person shall change the filing to the original filing department, and submit an explanation of the change and relevant documents. The drug regulatory department shall publish the changes in the filing information.
Article 89 If the management category of the filed medical device is adjusted to the second or third category medical device, it shall apply for registration 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 and approval of medical device 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 medical device registration application and clinical trial application, the drug regulatory department shall transfer the application materials to the technical review agency within 3 days from the date of acceptance. The requirements for acceptance of clinical trial applications shall apply to the provisions of Article 53 of these Measures.
Article 92 The time limit for technical review of medical device registration shall be implemented in accordance with the following provisions:
(1) The time limit for technical review of an application for a clinical trial of medical devices is 60 days, and the time limit for technical review after the application materials are supplemented and corrected is 40 days;
(2) The time limit for technical review of Class II medical device registration applications, registration modification applications, and registration renewal applications is 60 days, and the time limit for technical review after application materials are supplemented and corrected is 60 days;
(3) The time limit for technical review of Class III medical device registration applications, registration modification applications, and registration renewal applications is 90 days, and the time limit for technical review after application materials are supplemented and corrected is 60 days.
Article 93 The time limit for the inspection of the quality management system of domestic Class III medical devices 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 acceptance of the medical device registration application;
(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 medical device registration approval.
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) The time required for external expert consultation, holding expert consultation meetings, and joint review with drug review institutions for drug-device combination products;
(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 medical devices, and may conduct extended inspections of units and individuals that provide products or services for the research and development of medical devices when necessary, and relevant units and individuals shall cooperate and provide relevant documents and information, 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 medical device 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 discover the systematic and regional risks of medical device registration management within its administrative region in a timely manner, or fails to eliminate the systematic and regional hidden dangers of medical device registration management within its own administrative region in a timely manner, the higher-level drug The supervisory and administrative department may interview the main person in charge of the lower-level drug supervisory and administrative department.
Chapter IX Legal Liability
Article 107 Those who violate the provisions of Article 79 of these Measures and fail to record 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 medical devices 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 medical device registration or filing unit is divided in principle based on the technical principle, structural composition, performance index and scope of application of the product.
Article 112 The medical device approved for registration refers to the medical device that is consistent with the limited content of the medical device registration certificate and its attachments and produced within the validity period of the medical device registration certificate.
Article 113 The combined components specified in the "Structure and Composition" column of the medical device registration certificate, which are used for the original registered products for the purpose of replacing consumables, after-sales service, and maintenance, can be sold separately.
Article 114 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 medical device product registration, change registration, and clinical trial approval. The relevant working procedures for the registration of medical device master files shall be stipulated separately.
Article 115 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:
Domestic third-class medical devices, imported second-class, third-class medical devices are the word "country";
The domestic second-class medical device is the abbreviation of the province, autonomous region or municipality directly under the Central Government where the registration approval department is located;
×2 is the registration form:
The word "quasi" applies to domestic medical devices;
The word "jin" applies to imported medical devices;
The word "Xu" applies to medical devices 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 116 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 first-class medical equipment is the word "country";
The domestic first-class medical device 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, and municipality directly under the Central Government);
××××2 is the filing year;
××××3 is the record serial number.
Article 117 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 118 According to the needs of the work, the State Drug Administration may entrust the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government, technical institutions, and social organizations to undertake relevant specific work.
Article 119 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government may formulate special registration procedures for Class II medical devices within their respective administrative regions with reference to Chapter IV of these Measures, and report to the State Drug Administration for the record.
Article 120 The charging items and charging standards for the registration of medical device products shall be implemented in accordance with the relevant regulations of the financial and pricing departments of the State Council.
Article 121 The registration and filing of in-vitro diagnostic reagents under the management of medical devices shall be governed by the Administrative Measures for the Registration and Filing of In-Vitro Diagnostic Reagents.
Article 122 The relevant provisions on the supervision and administration of customized medical devices shall be formulated separately by the State Drug Administration.
The relevant regulations on the registration management of drug-device combination products shall be formulated separately by the State Drug Administration.
The relevant regulations on the emergency use of medical devices shall be formulated separately by the State Drug Administration in conjunction with relevant departments.
Article 123 The registration and filing of medical devices in Hong Kong, Macau and Taiwan shall be handled with reference to imported medical devices.
Article 124 These Measures shall come into force on October 1, 2021. On July 30, 2014, the "Administrative Measures for Medical Device Registration" promulgated by Order No. 4 of the former State Food and Drug Administration shall be repealed at the same time .
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