[Policies and Regulations] "Medical Device Registration and Filing Management Measures"
Issuing time:2021-09-25 22:34
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 medical device registration, filing and supervision and management activities within the territory of the People's Republic of China.
Article 3 Medical device registration means that the medical device registration applicant (hereinafter referred to as the applicant) submits an application for medical device registration in accordance with statutory procedures and requirements. The drug supervision and administration department shall, in accordance with laws and regulations, and based on scientific understanding, conduct safety, security, and effectiveness. Review of the nature and quality controllability, etc., to decide whether to approve the activities they have applied for.
Medical device filing refers to the activity of the medical device filing person (hereinafter referred to as the filing person) submitting filing materials to the drug regulatory authority in accordance with legal procedures and requirements, and the drug regulatory authority filing the submitted filing materials for review.
Article 4 The National Drug Administration is in charge of the national medical device registration and filing management, is responsible for establishing the medical device registration and filing management system and system, and organizes the domestic third category and the import of the second and third categories of medical devices in accordance with the law Review and approve, import first-class medical device filing and related supervision and management work, and supervise and guide the registration and filing of local medical devices.
Article 5 The Medical Device Technical Evaluation Center of the National Medical Products Administration (hereinafter referred to as the National Medical Device Evaluation Center) is responsible for the clinical trial applications of medical devices that require clinical trial approval, as well as the domestic third category and imported second category , The technical review of the third-class medical device product registration application, change registration application, renewal registration application, etc.
National Drug Administration Medical Device Standards Management Center, China Food and Drug Administration, National Drug Administration Food and Drug Inspection Center (hereinafter referred to as National Drug Administration Review and Inspection Center), National Drug Administration The National Drug Evaluation Center, the National Drug Administration Administrative Matters Acceptance Service and Complaint Reporting Center, the National Drug Administration Information Center and other professional technical institutions, according to their responsibilities, undertake the implementation of medical device standards required for the supervision and management of medical devices Management, classification and definition, inspection, verification, monitoring and evaluation, certification and delivery, and corresponding informatization construction and management.
Article 6 The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the management of the following medical device registration in their respective administrative regions:
(1) Domestic Class II medical device registration review and approval;
(2) Verification of the quality management system of domestic Class II and Class III medical devices;
(3) Organizing medical device clinical trial institutions and the supervision and management of clinical trials in accordance with the law;
(4) Supervision and guidance for the filing of Class I medical devices within the territory of the department responsible for drug supervision and management of the city divided into districts.
Medical device professional technical institutions set up by the drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for 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 management at the city level divided into districts shall be responsible for the filing and management of domestic Class I medical device products.
Article 7 The registration and filing management of medical devices shall follow the principles of law, science, openness, fairness and justice.
Article 8. First-class medical devices are subject to product filing management. The second and third categories of medical devices are subject to product registration management.
For the filing of domestic Class I medical devices, the filing person shall submit the filing materials to the department in charge of drug supervision and management at the city level with districts.
The second category of domestic medical devices shall be reviewed by the drug regulatory authorities of provinces, autonomous regions, and municipalities 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 National Drug Administration, and a medical device registration certificate will be issued after approval.
For the filing of imported Class I medical devices, the filing person shall submit the filing materials to the National Drug Administration.
Imported Class II and Class III medical devices will be reviewed by the National Drug Administration, and a medical device registration certificate will be issued after approval.
Article 9 The registrant and recorder of medical devices shall strengthen the quality management of the whole life cycle of medical devices, and shall be responsible for the safety, effectiveness and quality controllability of the medical devices in the whole process of development, production, operation and use. .
Article 10 The State Administration of Drug Administration shall give priority to clinical examination and approval of medical devices in urgent need, special examination and approval of innovative medical devices, encourage 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 R&D and registration applications.
Article 12 The drug supervision and administration department shall disclose medical device registration and filing related information in a timely manner in accordance with the law. Applicants can inquire about the progress and results of the examination and approval, and the public can consult the results of the examination and approval.
Without the consent of the applicant, the drug regulatory authority, 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 the filing party, as otherwise provided by law or Except for those involving national, family safety, security, and major social and public interests.
Chapter Two: 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 the safety of registered and filing medical devices. Effective, quality controllable, to ensure that the entire process information is true, accurate, complete and traceable.
Article 14 The applicant and filing person shall be an enterprise or research institution that can bear corresponding legal responsibilities. Overseas applicants and filing parties should **the corporate legal person in China as their agent, handle relevant medical device registration and filing matters. The agent shall assist the registrant and the filing party in fulfilling the obligations stipulated in Article 20, paragraph 1, of the Regulations on the Supervision and Administration of Medical Devices, and assist the overseas registrant and filing party in fulfilling the corresponding legal responsibilities.
Article 15 The applicant and recorder shall establish a quality management system suitable for the product and maintain effective operation.
Article 16 The personnel handling medical device registration and filing matters shall have corresponding professional knowledge and be familiar with the laws, regulations, rules and relevant regulations of 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 shall be provided at the same time. When citing unpublished documents and materials, documents permitted to be used by the owner of the materials shall be provided.
Article 18 To apply for the registration of imported medical devices, and to handle the filing of imported medical devices, the applicant, the filing person, or the country (region) where the country (region) of production is located, shall submit the certification documents that permit the medical device to be marketed.
If the applicant, the place of registration or the country (region) where the place of production is located, does not manage the product as a medical device, the applicant and the place of record must provide relevant documents, including the country (region) where the place of registration or place of production is located. Documents that permit the product to be sold on the market.
Innovative medical devices that are not listed in the country (region) where the applicant, the filing person is registered or where the place of 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 method, etc. are inconsistent with the scope of application of the mandatory standards, the applicant and filing party shall provide an explanation on the non-applicability of the mandatory standards and provide relevant materials.
If there are no mandatory standards, applicants and recorders are encouraged to adopt recommended standards.
Article 20 The registration and filing of medical devices shall follow the relevant requirements of the medical device classification rules and classification catalogs.
Article 21 The drug regulatory department continues to promote the reform of the review, review and approval system, strengthen scientific research on medical device supervision, and establish a medical device registration management technology system based on technical review and evaluation, and supported by verification, inspection, monitoring and evaluation. Optimize the review, review and approval process, improve review, review and approval capabilities, and improve the quality and efficiency of review, review and approval.
Article 22 The medical device professional technical institution shall establish a sound communication system, clarify the form and content of communication, and organize communication with applicants according to work needs.
Article 23 The medical device professional technical institution shall establish an expert consultation system according to work needs, listen to expert opinions on major issues in the process of review, verification, and inspection, 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, consider the existing recognized technology level, ensure that the products are ** known and foreseeable risks and unintended effects are minimized and acceptable, and that the products are in normal use The benefits outweigh the risks.
Article 25 Anyone engaged in the research and development of medical device products shall meet the requirements of relevant Chinese laws, regulations and mandatory standards.
Article 26 The applicant and the filing person shall compile the product technical requirements for the application for registration or the filing of medical devices.
Product technical requirements mainly include functional and safety indicators and testing methods that can be objectively judged for finished medical devices.
Medical devices shall meet the product technical requirements that have been registered or filed.
Article 27 The applicant and the filing party shall prepare the product manuals and labels of the medical devices applying for registration or filing.
Product instructions and labels shall comply with the requirements of Article 39 and relevant regulations of the Regulations on the Supervision and Administration of Medical Devices.
Article 28 In the research and development of medical devices, non-clinical research on medical devices shall be carried out in accordance with the scope of application and technical characteristics of the products.
Non-clinical research includes product chemical and physical performance research, electrical safety research, radiation safety research, software research, biological characteristics research, biological source material safety research, disinfection and sterilization process research, animal experiment research , Stability research, etc.
When applying for registration or filing, non-clinical evidence generated during research and development activities shall be submitted, including a summary of non-clinical research reports, research plans and research reports.
Article 29 The functional and safety indicators and methods determined in the process of medical device non-clinical research should be compatible with the expected use conditions and purpose of the product, and the research samples should be representative and typical. When necessary, methodological verification and statistical analysis shall be carried out.
Article 30 In applying for registration or filing, the inspection shall be carried out in accordance with the technical requirements of the product and an inspection report shall be submitted. Only those who pass the inspection can start clinical trials or apply for registration and filing.
Article 31 The products for inspection shall be able to represent the safety and effectiveness of the products applying for registration or filing, and their production shall comply with the relevant requirements of the medical device production quality management regulations.
Article 32 The medical device product inspection report submitted for registration or filing may be a self-inspection report of the applicant or filing person, or an inspection report issued by a qualified medical device inspection agency.
Section 2 Clinical Evaluation
Article 33 Except for the circumstances stipulated 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 use of scientific and reasonable methods to analyze and evaluate clinical data to confirm the safety and effectiveness of medical devices within their scope of application. To apply for medical device registration, clinical evaluation materials should be submitted.
Article 34 Those in any of the following circumstances may be exempt from clinical evaluation:
(1) The working mechanism is clear, the design is finalized, the production process is mature, the medical devices of the same variety that have been marketed have been used in clinical applications for many years, there is no record of serious adverse events, and the conventional use is not changed;
(2) Other non-clinical evaluations that can prove the safety and effectiveness of the medical device.
Those who are exempt from clinical evaluation may be exempt from submitting clinical evaluation data.
The list of medical devices exempt from clinical evaluation shall be formulated, adjusted and published by the National Drug Administration.
Article 35 The clinical evaluation of medical devices can be carried out according to the product characteristics, clinical risks, existing clinical data, etc., through clinical trials, or through analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices to prove the medical treatment. The safety and effectiveness of the device.
According to the regulations of the National Drug Administration, when conducting clinical evaluation of medical devices, if the existing clinical literature and clinical data are not enough to confirm the product safety and effectiveness of medical devices, clinical trials should be carried out.
The National Drug Administration has formulated guidelines for clinical evaluation of medical devices, clarifying the requirements for clinical evaluation through the clinical literature and clinical data of the same variety of medical devices, the circumstances in which clinical trials need to be carried out, and the requirements for writing clinical evaluation reports.
Article 36 For clinical evaluations based on the clinical documentation and clinical data of the same variety of medical devices, the clinical evaluation data includes the comparison between the product applied for registration 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 between the product applied for registration and the 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, clinical trial reports, etc.
Article 37 The clinical trials of medical devices shall be carried out in medical device clinical trial institutions that have the corresponding conditions and are filed in accordance with the regulations in accordance with the requirements of the medical device clinical trial quality management specifications. Before the start of a clinical trial, the clinical trial sponsor shall file a clinical trial record with the local drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government. The production of clinical trial medical devices shall comply with the relevant requirements of the medical device production quality management norms.
Article 38 The clinical trials of Class III medical devices that pose a high risk to the human body shall be approved by the State Drug Administration.
Clinical trial approval refers to the comprehensive analysis of the medical device's risk level, clinical trial plan, clinical benefit and risk comparison analysis report, etc., based on the applicant's application, to determine whether to agree or not. The process of conducting clinical trials.
The list of the third category of medical devices subject to clinical trial approval is formulated, adjusted and published by the National Drug Administration. The third-class medical device clinical trials that require clinical trial approval should be carried out in third-class medical institutions that meet the requirements.
Article 39 Where medical device clinical trial approval is required, the applicant shall