SFDA issues special approval procedures for innovative medical devices

On February 7, in order to ensure the safety and effectiveness of medical devices, encourage the research and innovation of medical devices, promote the promotion and application of new technologies of medical devices, and promote the development of medical device industry, the State Food and Drug Administration issued the special approval procedure for innovative medical devices (Trial) In order to ensure the safety and effectiveness of medical devices, encourage the research and innovation of medical devices, promote the promotion and application of new technologies of medical devices, and promote the development of medical device industry, the State Food and Drug Administration (CFDA) organized and formulated the special approval procedure for innovative medical devices (Trial), and published the document on February 7 The full text of the document is as follows: Special approval procedures for innovative medical devices (Trial) Article 1 in order to ensure the safety and effectiveness of medical devices, encourage the research and innovation of medical devices, promote the promotion 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, the measures for the administration of registration of medical devices and other regulations and rules Article 2 the food and drug administration shall review and approve the medical devices meeting the following conditions in accordance with this procedure: (1) the applicant has the patent right for the invention of the core technology of the product in China according to law through its leading technological innovation activities, or has obtained the patent right for the invention of the core technology in China or the right to use it according to law through the transfer; or the application for the patent for the invention of the core technology has been made public by the patent administration department under the State Council (II) the main working principle / action mechanism of the product is the first in China The performance or safety of the product is fundamentally improved compared with similar products, and the technology is at the international leading level, and has significant clinical application value (3) the applicant has completed the preliminary research of the product and has basically finalized the product, the research process is real and controlled, and the research data is complete and traceable Article 3 food and drug supervision and administration 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 in accordance with the principles of early intervention, special personnel in charge and scientific examination and approval, and strengthen communication and exchange with applicants on the premise of no reduction in standards and procedures Article 4 when applying 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 materials supporting the products to be applied to meet the requirements of Article 2 of this procedure The materials shall include: (1) the certification documents of the applicant's enterprise legal person qualification (2) product intellectual property rights and supporting documents (3) overview of product development process and results (IV) product technical documents shall at least include: 1 Intended use of the product; 2 Working principle / action mechanism of the product; 3 Main technical indexes and determination basis of the product, index requirements of main raw materials and key components, main production process and flow chart, inspection methods of main technical indexes (5) the documentary evidence of product innovation shall at least include: 1 The novelty search report issued by the information or patent retrieval institution; 2 The summary of academic papers, monographs and documents published in the core journals that can fully explain the clinical application value of the products; 3 The analysis and comparison of the application of the same products at home and abroad (if any); 4 Innovative content of the product and its significant value in clinical application (6) product safety risk management report (7) product manual (sample) (8) other materials proving that the products conform to Article 2 of these procedures (9) an overseas applicant shall entrust an enterprise legal person within the territory of China as an agent or its office within the territory of China to file an application, and shall submit the following documents: 1 Power of attorney for an overseas applicant to entrust an agent or its office within the territory of China to handle the application for special examination and approval of innovative medical devices; 2 Letter of commitment of the agent or applicant's office in China; 3 Business license of the agent or organization registration certificate of the applicant's office in China 10 Self assurance statement of the authenticity of the submitted materials The application materials shall be in Chinese Where the original text is in a foreign language, there shall be a Chinese translation Article 5 the domestic applicant shall apply to the local provincial food and Drug Administration for special examination and approval of innovative medical devices The provincial food and drug administration shall conduct a preliminary examination on whether the application project meets the requirements of Article 2 of this procedure, and issue the preliminary examination opinions within 20 working days If the preliminary examination fails to meet the requirements of Article 2, the provincial food and drug administration shall notify the applicant; if the requirements of Article 2 are met, the provincial food and drug administration shall submit the application materials and the preliminary examination opinions to the administrative acceptance service center of the State Food and Drug Administration (hereinafter referred to as the food and Drug Administration) Overseas applicants shall apply to the State Food and Drug Administration for special examination and approval of innovative medical devices The administrative acceptance service center of the State Food and drug administration shall conduct formal examination on the application materials and accept those that meet the requirements of Article 4 of this procedure Article 6 the administrative acceptance service center of the food and drug administration shall give the acceptance number of the application for special product approval to the application for special product approval, and the arrangement of the acceptance number is as follows: xxx 1 - XXX 2, where xxx 1 is the year of application; XXX 2 is the serial number of the product Article 7 the technical evaluation center for medical devices of the food and drug administration shall establish an innovative medical device Examination Office (hereinafter referred to as the innovative medical device Examination Office) to examine the application for special examination and approval of innovative medical devices Article 8 after the food and drug administration accepts the application for special examination and approval of innovative medical devices, the office of examination and approval of innovative medical devices shall organize experts to conduct examination and issue examination opinions within 40 working days after acceptance Article 9 after examination by the innovation medical device examination office, the application items to be specially examined and approved shall be publicized on the website of the medical device technical examination center of the food and drug administration, and the time of publicity shall not be less than 10 working days If there is any objection to the publicity, the final examination decision shall be made after studying the relevant opinions Article 10 after the innovative medical device examination office makes the examination decision, it shall notify the applicant in writing of the examination result, and send a copy of the application to the local provincial food and Drug Administration (see Annex 2 for the format) Article 11 when examining the application for special examination and approval of innovative medical devices, the examination office of innovative medical devices shall define the management categories of medical devices For domestic enterprise applications, if the products are defined as class II or class I medical devices, the corresponding provincial or city level food and drug supervision and administration departments can refer to this procedure for follow-up work, review and approval Article 12 for innovative medical devices approved in accordance with this procedure after examination and approval, the food and Drug Administration in the place where the applicant is located shall designate a special person to timely communicate and provide guidance at the request of the applicant After receiving the applicant's application for quality management system inspection (assessment), priority shall be given to it Article 13 for innovative medical devices, when conducting registration test, the medical device testing institution shall timely pre evaluate the registered product standard submitted by the manufacturer, and timely propose modification suggestions to the manufacturer if there are problems Article 14 after receiving the samples, the medical device testing institution shall give priority to the registration testing of medical devices and issue the testing report The registered product standard pre evaluated by the medical device testing institution and the pre evaluation opinion form of the product standard to be applied for registration shall be sealed by the testing institution and issued together with the testing report Article 15 the clinical trials of innovative medical devices shall be conducted in accordance with the requirements of the relevant provisions on clinical trials of medical devices, and the food and drug administration shall conduct supervision and inspection in accordance with the process of clinical trials Article 16 if the clinical research work of innovative medical devices needs major changes, such as the revision of clinical trial scheme, the adjustment of use method, specification and model, intended use, scope of application or population, the applicant shall evaluate the impact of changes on the safety, effectiveness and quality controllability of medical devices Innovative medical devices whose main working principle or mechanism of action has changed shall be reapplied in accordance with this approval procedure Article 17 for innovative medical devices, before the application for product registration is accepted and during the technical review, the technical review center of medical devices of the food and drug administration shall designate a special person to timely communicate and provide guidance at the request of the applicant, and jointly discuss relevant technical issues Article 18 for innovative medical devices, the applicant can fill in the application form for communication and exchange of innovative medical devices (see Annex 3), and submit an application for communication and exchange to the technical evaluation center of medical devices of the food and Drug Administration on the following issues: (1) major technical issues; (2) major safety issues; (3) clinical trial scheme; (4) summary and evaluation of the results of staged clinical trials; and (5) other important issues requiring communication and exchange Article 19 the technical evaluation center of medical devices of the food and drug administration shall timely review the communication and exchange application and relevant materials submitted by the applicant, and notify the applicant of the review results (see Annex 4) If the technical evaluation center of medical devices of the food and Drug Administration agrees to conduct communication, it shall clearly inform the applicant of the issues to be discussed, negotiate with the applicant on the form, time, place, participants, etc of communication, and arrange communication with the applicant Communication and exchange shall be recorded, which shall be signed and confirmed by both parties for reference of subsequent research and review of the product 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 transfer the registration application materials Article 21 for the innovative medical devices that have accepted the registration application, the technical evaluation center of the medical devices of the food and drug administration shall give priority to the technical evaluation; after the technical evaluation, the food and drug administration shall give priority to the administrative examination and approval Article 22 under any of the following circumstances, the food and drug administration may terminate this procedure and inform the applicant: (1) the applicant voluntarily requests termination; (2) the applicant fails to fulfill the corresponding obligations within the prescribed time and requirements; (3) the applicant provides forged and false information; (4) it is determined by the expert review meeting that it is no longer suitable to manage according to this procedure Article 23 in the process of implementing this procedure, the food and drug administration shall strengthen the communication and exchange with the relevant departments of the State Council, and timely understand the research and development progress of innovative medical devices Article 24 the medical devices needed for the emergency of public health emergencies shall be handled in accordance with the emergency approval procedure for medical devices Article 25 the requirements and regulations for the registration management of medical devices that are not involved in this procedure shall be in accordance with the measures for the registration management of medical devices and other relevant regulations