Special Approval Procedures for Innovative Medical Devices (Trial)
Article 1 In order to safeguard the safety and effectiveness of medical devices, encourage research and innovation of medical devices, promote the promotion and application of new technologies for medical devices, and promote the development of the medical device industry, in accordance with the "Supervision and Administration of Medical Devices Regulations", "Measures for the Administration of Registration of Medical Devices" and other statutes and regulations, to formulate the procedures. Article 2 The food and drug supervision and management department of the medical device at the same time meets the following circumstances in accordance with this procedure for the implementation of review and approval: (a) the applicant, after its leading technological innovation activities, according to law in China has the core technology of the product invention patent rights, or according to law through the transfer of the invention patent rights in China or the use of its rights; or the core technology invention patent application has been made public by the State Council's patent administrative department. (ii) The main working principle/mechanism of the product is the first of its kind in China, the performance or safety of the product has been fundamentally improved in comparison with similar products, and the technology is at the international leading level, and it has significant clinical application value. (C) the applicant has completed the preliminary study of the product and the basic stereotypes of the product, the research process is real and controlled, the research data is complete and traceable. Article 3 The food and drug supervision and management departments at all levels and relevant technical institutions, in accordance with their respective responsibilities and the provisions of this procedure, in accordance with the principles of early intervention, specialization and scientific approval, under the premise of not lowering the standards and not reducing the procedures, the innovative medical devices shall be prioritized and communication with the applicant shall be strengthened. Article 4 The applicant applying for special approval of innovative medical devices shall fill in the "Application Form for Special Approval of Innovative Medical Devices" (see Annex 1) and submit the information supporting the proposed application for the product to meet the requirements of Article 2 of this procedure. The information shall include: (a) Documents proving the applicant's corporate qualification. (ii) Product intellectual property rights and supporting documents. (iii) An overview of the product development process and results. (D) product technical documents, at least should include: 1. the intended use of the product; 2. the product's working principle / mechanism; 3. the product's main technical indicators and the basis for determining the main raw materials, key components of the index requirements, the main production process and flow charts, the main technical indicators of the test method. (E) product innovation documents, at least should include: 1. information or patent search agency issued a new report; 2. core publications published in the public can fully explain the value of the clinical application of the product's academic papers, monographs and document review; 3. domestic and foreign marketed similar products and the analysis of the application of the situation and comparison (if any); 4. the innovative content of the product and the clinical application of the value of the significant. (F) Product safety risk management report. (VII) Product specification (sample). (H) Other information to prove that the product complies with Article 2 of this program. (Ix) The foreign applicant shall entrust the enterprise legal person in China as an agent or its office in China to make the application, and submit the following documents: 1. The foreign applicant entrusts the agent or its office in China to handle the application for special approval of the innovative medical device power of attorney; 2. The agent or the applicant's office in China's letter of commitment; 3. The agent's business license Or the applicant's office in China's institutional registration certificate. (J) submitted information on the authenticity of the self-assurance statement. Declaration of information should be used in Chinese. The original foreign language, there should be a Chinese translation. Article V domestic applicants should be its location to the provincial food and drug supervision and management departments to submit a special application for approval of innovative medical devices. Provincial food and drug supervision and management departments to declare whether the project meets the requirements of Article 2 of this procedure for preliminary examination, and within 20 working days to issue a preliminary opinion. After the preliminary examination does not meet the requirements of Article 2, the provincial food and drug supervision and management departments shall notify the applicant; meet the requirements of Article 2, the provincial food and drug supervision and management departments will be reported to the State Food and Drug Administration (hereinafter referred to as the General Administration of Food and Drug Administration) administrative acceptance of the service center. Overseas applicants shall apply to the Food and Drug Administration for special approval of innovative medical devices, the Food and Drug Administration Administrative Acceptance Service Center for formal review of the declarations, in line with the formal requirements set out in Article IV of this procedure shall be accepted. Article 7 The Medical Device Technical Review Center of the Food and Drug Administration establishes the Innovative Medical Device Review Office (hereinafter referred to as the Innovative Medical Device Review Office) to review the application for special approval of innovative medical devices. Article 8 The Food and Drug Administration accepts the application for special approval of innovative medical devices, the innovative medical device review office to organize expert review, and acceptance within 40 working days after the issuance of the review opinion. Article IX reviewed by the Office of Innovative Medical Devices Review, the proposed special approval of the application, should be in the Food and Drug Administration Medical Device Technical Review Center website will be the applicant, the product name to be publicized, the publicity time should be not less than 10 working days. For the publicity of objections, the relevant comments should be studied to make a final review decision. Article 10 The innovative medical device review office to make a review decision, the review results will be notified in writing to the applicant, the application of domestic enterprises, while copying the applicant's local provincial food and drug supervision and management departments (format see Annex 2). Article 11 The Office for the Review of Innovative Medical Devices shall define the management category of medical devices when reviewing the application for special approval of innovative medical devices. For the application of domestic enterprises, if the product is defined as Class II or Class I medical devices, the corresponding provincial or municipal food and drug supervision and management departments can refer to this procedure for follow-up work and review and approval. Article 12 For the review and approval of innovative medical devices agreed in accordance with this procedure, the applicant's local food and drug supervision and management department shall designate a person, at the request of the applicant to communicate in a timely manner, provide guidance. Upon receipt of the applicant's quality management system inspection (assessment) application, should be prioritized. Article 13 For innovative medical devices, medical device testing organizations in the registration test, should be submitted to the manufacturer of registered products in a timely manner to pre-evaluation of standards, the existence of problems, should be promptly proposed to the manufacturer to modify the recommendations. Article 14 The medical device testing organization shall prioritize the medical device registration test after accepting the sample and issue the test report. After the medical device testing organizations pre-evaluation of registered product standards and "to apply for registration of medical devices product standards pre-evaluation opinion form" should be stamped with the seal of the testing organization, along with the test report issued. Article 15 The clinical trial of innovative medical devices shall be conducted in accordance with the requirements of the relevant provisions of the clinical trial of medical devices, and the food and drug administration department shall supervise and inspect the clinical trial according to the process. Article 16 If the clinical research of innovative medical devices requires significant changes, such as revision of clinical trial program, adjustment of the use method, specifications, intended use, scope of application or population, etc., the applicant shall assess the impact of the changes on the safety, efficacy and quality controllability of the medical device. Innovative medical devices with changes in the main working principle or mechanism of action of the product shall be reapplied in accordance with this approval procedure. Article XVII for innovative medical devices, product registration application before acceptance and technical review process, the Food and Drug Administration Medical Device Technical Review Center shall designate a person, at the request of the applicant to communicate in a timely manner to provide guidance, *** with the discussion of relevant technical issues. Article 18 For innovative medical devices, the applicant can fill out the application form for communication and exchange of innovative medical devices (see Annex 3), on the following issues to the Center for Technical Review of Medical Devices of the Food and Drug Administration to submit applications for communication and exchange: (a) major technical issues; (b) significant safety issues; (c) clinical trial program; (d) the summary and evaluation of the results of the phased clinical trials; (e) other important issues that require communication and exchange. (e) other important issues that require communication. Article 19 The Center for Technical Review of Medical Devices of the Food and Drug Administration shall review the application for communication and exchange of relevant information submitted by the applicant in a timely manner and notify the applicant of the results of the review (see Annex 4). Food and Drug Administration Medical Device Technical Review Center agreed to communicate with the applicant, should clearly inform the applicant of the issues to be discussed, and the applicant to agree on the form of communication, time, location, participants, etc., to arrange for communication with the applicant. Communication should form a record, the record needs to be signed by both parties to confirm, for the product's subsequent research and review work for reference. Article 20 The Food and Drug Administration accepts the application for registration of innovative medical devices, the registration application should be labeled as "innovative medical devices", and timely flow of registration information. Article 21 has accepted the registration of innovative medical devices, the Food and Drug Administration Medical Device Technical Review Center shall give priority to the technical review; after the completion of the technical review, the Food and Drug Administration shall give priority to administrative approval. Article 22 belongs to one of the following circumstances, the Food and Drug Administration may terminate the program and inform the applicant: (a) the applicant takes the initiative to request the termination; (b) the applicant fails to fulfill the corresponding obligations in accordance with the specified time and requirements; (c) the applicant to provide forged and false information; (d) by the expert review meeting to determine that it is not appropriate to follow the procedures of management. Article 23 The General Administration of Food and Drug Administration shall, in the process of implementing this Procedure, strengthen the communication and exchange with the relevant departments of the State Council, and keep abreast of the progress of the research and development of innovative medical devices. Article 24 The medical devices required for the emergency response to public **** health emergencies shall be handled in accordance with the "Medical Device Emergency Approval Procedures". Article 25 The requirements and provisions of medical device registration management, which are not covered by this procedure, shall be implemented in accordance with the Measures for the Administration of Medical Device Registration and other relevant provisions. Article 26 This procedure shall come into force from March 1, 2014 onwards. Attachment: 1. Innovative Medical Device Special Approval Application Form (omitted) 2. Innovative Medical Device Special Approval Application Review Notification Form (omitted) 3. Innovative Medical Device Communication and Exchange Application Form (omitted) 4. Innovative Medical Device Communication and Exchange Application Response Form (omitted)