Article 1 In order to ensure the safety and effectiveness of medical devices, encourage the research and innovation of medical devices, promote the popularization and application of new technologies of medical devices, and promote the development of medical device industry, this procedure is formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Administration of Medical Device Registration. Article 2 The food and drug supervision and administration department shall review and approve medical devices that meet the following conditions in accordance with this procedure: (1) The applicant has the patent right of product core technology invention in China according to law through its leading technological innovation activities, or has obtained the patent right or use right of China invention through transferee according to law; Or the application for a patent for invention of the core technology has been made public by the patent administration department of the State Council. (two) the main working principle/mechanism of the product is the first in China, the performance or safety of the product is fundamentally improved compared with similar products, the technology is at the international leading level, and it has significant clinical application value. (three) the applicant has completed the preliminary research of the product and has basically finalized it, the research process is real and controllable, and the research data is complete and traceable. Article 3 Food and drug supervision and management departments at all levels and relevant technical institutions shall, in accordance with their respective responsibilities and the provisions of this procedure, give priority to innovative medical devices and strengthen communication with applicants on the premise of not lowering standards and procedures, and in accordance with the principles of early intervention, special person in charge and scientific examination and approval. Article 4 To apply for special examination and approval of innovative medical devices, the applicant shall fill in the Application Form for Special Examination and Approval of Innovative Medical Devices (see Annex 1) and submit the certification materials that the products applied for meet the requirements of Article 2 of this procedure. The materials shall include: (1) the applicant's certificate of enterprise legal person qualification. (2) Product intellectual property information and supporting documents. (3) Summary of product development process and results. (4) Product technical documents shall at least include: 1. The intended use of the product; 2. Working principle/mechanism of the product; 3. The main technical indicators of the product and the basis for determination, the index requirements of the main raw materials and key components, the main production process and flow chart, and the inspection methods of the main technical indicators. (5) The certification documents of product innovation shall at least include: 1. Information or novelty retrieval report issued by the patent retrieval institution; 2 abstracts of academic papers, monographs and documents published in core journals that can fully explain the clinical application value of products; 3. Application analysis and comparison of similar products listed at home and abroad (if any); 4. The innovative content of the product and its significant clinical application value. (six) product safety risk management report. (7) Product description (sample draft). (eight) other documents to prove that the product conforms to the second article of this regulation. (9) An overseas applicant shall entrust an enterprise legal person in China as an agent or its office in China to apply and submit the following documents: 1. Power of attorney for the overseas applicant to entrust his agent or his office in China to handle the application for special examination and approval of innovative medical devices; 2. Letter of commitment from the agent or the applicant's office in China; 3. The business license of the agent or the institution registration certificate of the applicant's office in China. (10) A self-assurance statement on the authenticity of the submitted materials. The application materials shall be in Chinese. If the original text is in a foreign language, there should be a Chinese translation. Article 5 A domestic applicant shall submit an application for special examination and approval of innovative medical devices to the local provincial food and drug supervision and administration department. The provincial food and drug supervision and administration department shall conduct a preliminary examination on whether the declared project meets the requirements of Article 2 of this procedure, and issue a preliminary examination opinion within 20 working days. If the preliminary examination does not meet the requirements of Article 2, the provincial food and drug supervision and administration department shall notify the applicant; In line with the requirements of Article 2, the provincial food and drug administration department shall submit the application materials and preliminary examination opinions to the Administrative Acceptance Service Center of China Food and Drug Administration (hereinafter referred to as the Food and Drug Administration). An overseas applicant shall submit an application for special examination and approval of innovative medical devices to the Food and Drug Administration, and the administrative acceptance service center of the Food and Drug Administration shall examine the application materials in form, and accept them if they meet the formal requirements as stipulated in Article 4 of this procedure. Article 6 The Administrative Acceptance Service Center of the General Administration of Food and Drug Administration of the United States shall give the acceptance number of the application for special product approval, and the arrangement of the acceptance number is: special machinery ××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××××× 1 is the year of application; ×××? 2 is the serial number of the product. Article 7 The Medical Device Technology Evaluation Center of the Food and Drug Administration shall set up an innovative medical device evaluation office (hereinafter referred to as the innovative medical device evaluation office) to evaluate the application for special approval of innovative medical devices. Article 8 After the General Administration of Food and Drug Administration of the United States accepts the application for special examination and approval of innovative medical devices, the Office for Examination of Innovative Medical Devices shall organize experts to conduct examination and issue examination opinions within 40 working days after acceptance. Article 9 The applicant and product name of the application item specially approved by the Innovation Medical Device Evaluation Office shall be publicized on the website of the Medical Device Technology Evaluation Center of the Food and Drug Administration for no less than 10 working days. If there is any objection to the publicity, the final review decision shall be made after studying the relevant opinions. Article 10 After making a review decision, the innovative medical device review office shall notify the applicant in writing of the review results and send a copy to the provincial food and drug supervision and administration department where the applicant is located for domestic enterprises to apply for use (see Annex 2 for the format). Eleventh innovative medical device evaluation office in the review of innovative medical devices special approval applications, together with the definition of medical device management categories. Where a domestic enterprise applies for a product defined as Class II or Class I medical device, the corresponding provincial or municipal food and drug supervision and administration department may refer to this procedure for follow-up work, review and approval. Article 12 The food and drug supervision and administration department where the applicant is located shall designate a special person to communicate and guide the innovative medical devices in time according to the requirements of the applicant. After receiving the applicant's application for quality management system inspection (review), priority should be given. Thirteenth for innovative medical devices, medical device testing institutions shall timely pre-evaluate the registered product standards submitted by the production enterprises when conducting registration testing, and put forward suggestions for revision to the production enterprises in time when problems are found. Fourteenth medical device testing institutions shall give priority to the registration and testing of medical devices after receiving the samples, and issue a test report. The registered product standards pre-evaluated by medical device testing institutions and the pre-evaluation opinion form of medical device product standards applied for registration shall be stamped with the seal of the testing institution and issued together with the testing report. Fifteenth clinical trials of innovative medical devices should be carried out in accordance with the requirements of the relevant provisions of clinical trials of medical devices, and the food and drug supervision and administration department should conduct supervision and inspection according to the progress of clinical trials. Article 16 If the clinical research of innovative medical devices needs to modify the clinical trial scheme, adjust the use method, specifications, intended use, scope of application or population and other major changes, the applicant shall evaluate the impact of the changes on the safety, effectiveness and quality controllability of medical devices. Innovative medical devices whose main working principle or action mechanism has changed shall be reapplied in accordance with this examination and approval procedure. Article 17 For innovative medical devices, before the application for product registration is accepted and during the technical review, the Medical Device Technical Review Center of the Food and Drug Administration shall, according to the requirements of the applicant, designate a special person to communicate and guide in time and discuss relevant technical issues. Article 18 For innovative medical devices, the applicant may fill in the Application Form for Exchange and Exchange of Innovative Medical Devices (see Annex 3) and submit an application for exchange and exchange to the Medical Device Technology Evaluation Center of the Food and Drug Administration on the following issues: (1) Major technical issues; (2) Major security issues; (3) Clinical trial plan; (4) Summarizing and evaluating the results of staged clinical trials; (five) other important issues that need to be communicated. Article 19 The Medical Device Technology Evaluation Center of the Food and Drug Administration shall timely review the communication application and related materials submitted by the applicant, and notify the applicant of the review results (see Annex 4). If the Medical Device Technology Evaluation Center of the Food and Drug Administration agrees to communicate, it shall clearly inform the applicant of the issues to be discussed, agree with the applicant on the form, time, place and participants of communication, and arrange communication with the applicant. Communication should be recorded, and the records should be signed by both parties for reference in the follow-up research and evaluation of products. Article 20 After accepting the application for registration of innovative medical devices, the Food and Drug Administration shall mark the application items as "innovative medical devices" and timely circulate the application materials for registration. Twenty-first innovative medical devices that have accepted the registration declaration are given priority by the Medical Device Technology Evaluation Center of the Food and Drug Administration; After the technical review, the Food and Drug Administration will give priority to administrative examination and approval. Article 22 In any of the following circumstances, the Food and Drug Administration may terminate this procedure and notify the applicant: (1) The applicant voluntarily requests termination; (two) the applicant fails to fulfill the corresponding obligations according to the prescribed time and requirements; (3) The applicant provides forged and false information; (four) it is determined by the expert review meeting that it is not suitable for management in accordance with this procedure. Twenty-third food and drug administration in the process of implementing this regulation, it should strengthen communication and exchanges with relevant departments in the State Council, and keep abreast of the progress of research and development of innovative medical devices. Twenty-fourth public health emergencies emergency medical devices, in accordance with the "medical device emergency examination and approval procedures". Twenty-fifth medical device registration management requirements and regulations not involved in this regulation shall be implemented in accordance with the Measures for the Administration of Medical Device Registration and other relevant regulations. Article 26 This Regulation shall be implemented as of March 1 day, 2065438. Attachment: 1 Application form for special examination and approval of innovative medical devices (omitted) II. Notice on the examination of the application for special license for innovative medical devices (omitted) 3. Application Form for Innovative Medical Device Exchange (omitted) 4. Innovative medical device exchange reply form (omitted)