Innovative medical equipment special approval procedures revised draft for comments!

On May 8th, May 7th, the “Special Approval Procedure for Innovative Medical Devices” was put on the web for comments, and the deadline was June 15, 2018.

Article 1 To ensure the safety and effectiveness of medical devices, encourage research and innovation in medical devices, promote the promotion and application of new medical device technologies, and promote the development of medical device industries, according to the "Regulations on the Supervision and Management of Medical Devices" and the "Measures for the Registration of Medical Devices" 》《In vitro diagnostic reagents registration management measures》 Regulation And regulations, formulate this procedure.

Article 2 The pharmaceutical supervisory and administrative department shall review and approve the Type II and Type III medical devices that meet the following conditions in accordance with this procedure:

(1) The applicant has its patented technology innovation activity in China and holds patent rights for product core technology inventions in China according to law, or obtains the patent right or its use right in China through transfer. The filing date of the patent (prior to Priority date) Within 5 years of the application for the special approval procedure for innovative medical devices; or the application for patents for core technological inventions has been made public by the patent administration department of the State Council, and a search report is issued by the Patent Search and Consultation Center of the State Intellectual Property Office. The core technology of the products in the search report The program is novel and creative.

(2) The main working principle/mechanism of the product is domestically initiated. The performance or safety of the product is fundamentally improved compared with similar products, and it is technologically advanced at the international level. It also has significant clinical application value.

(3) The applicant has completed the preliminary study of the product and has basic stereotyped products. The research process is real and controlled. The research data is complete and traceable.

Article 3 The pharmaceutical supervisory and administrative departments and related technical agencies shall, in accordance with their respective responsibilities and the provisions of the procedures, follow the principle of early intervention, special personnel, and scientific approval, and give priority to innovative medical devices on the premise that the standards are not reduced and the procedures are not reduced. Handle and strengthen communication with the applicant.

Article 4 Where an applicant applies for special examination and approval for innovative medical devices, it shall fill in the Application Form for Special Approval of Innovative Medical Devices before submitting the first registration application for Type II and Type III medical devices, and submit the support for the proposed product to be in line with the second procedure. The required information. The information should include:

(a) The applicant's qualification certificate for the enterprise legal person.

(b) Product intellectual property and certification documents.

(3) Overview of product development process and results.

(iv) Product technical documentation, which should at least include:

1. The scope of application / intended use of the product;

2. Product working principle/function mechanism;

3. Main technical specifications and determination basis of the product, major raw materials, index requirements of key components, major production process and flow chart, and inspection methods for major technical indicators.

(5) Proof documents for product innovation, which shall at least include:

1. Core journals publish academic papers, monographs, and document summaries that can fully explain the clinical application value of products;

2. Analysis and comparison (if any) of the application of similar products at home and abroad;

3. Product innovation content and significant value in clinical applications.

(6) Product risk analysis data.

(7) Product description (sample draft)

(h) Other materials that prove that the product complies with Article 2 of this procedure.

(9) Overseas applicants should entrust corporate legal persons in China as proxy The person may submit an application by his office in China and submit the following documents:

1. Overseas applicants appoint agents or their offices in China to innovate medical instruments Special request for approval of the power of attorney;

2. The undertaking of the agent or the applicant's office in China;

3. Agency business license or agency registration certificate of the applicant's office in China.

(x) Self-assurance statement of the authenticity of the submitted data.

The application materials should be in Chinese. The original text is in foreign languages ​​and should have a Chinese translation.

Article 5 The domestic applicant shall submit an application for special examination and approval of innovative medical devices to the drug regulatory agency at the provincial level where it is located. The provincial drug regulatory agency shall conduct a preliminary examination on whether the declared project meets the requirements of Article 2 of the procedure and shall perform 20 tasks. If the preliminary examination fails to meet the requirements of the second article, the provincial drug regulatory authority shall inform the applicant; if the requirements of Article 2 are met, the provincial drug regulatory authority shall submit the application materials together with the preliminary examination opinions. The State Drug Administration (hereinafter referred to as the State Food and Drug Administration) administrative service center.

Overseas applicants should apply for special examination and approval of innovative medical devices to the State Food and Drug Administration. The Administrative Service Center of the State Food and Drug Administration shall conduct formal examination of the application materials and accept the formal requirements in accordance with Article 4 of this procedure.

For the application for special approval for innovative medical devices that have been accepted, the applicant may apply to withdraw the application for special approval for innovative medical devices and related materials before the review decision is made, and explain the reason.

Article 6 The administrative reception service center of the State Food and Drug Administration shall give a special approval application acceptance number to the application for special approval. The acceptance numbering arrangement is: CQTS××××1×××2, where ××××1 is The year of application; ×××2 is the product serial number.

Article 7 The State Drug Administration's Medical Device Technology Evaluation Center (hereinafter referred to as the Censorship Center) sets up an innovative medical device examination office to review the application for special approval for innovative medical devices.

Article 8: After receiving an application for special approval for innovative medical devices, the Administrative Service Center of the State Food and Drug Administration organizes an expert review by the Innovative Medical Device Examination Office. The innovative medical device examination office receives 40 applications for special approval applications for innovative medical devices. Organize experts for review within days; review comments within 20 working days after review by experts.

Article 9 After examination by the Office of Innovative Medical Device Examination, the applicants and product names shall be publicized on the website of the Censoring Center for the application projects to be specially approved. The publicity time shall be no less than 10 working days. In case of an objection, a final review decision shall be made after the relevant opinions have been studied.

Article 10 After the innovative medical device examination office makes a review decision, the review result shall be notified to the applicant through the website of the device examination center.

Within 3 years after the notification of the result of the review, if the corresponding medical device has not been declared registered, it will no longer be subject to review and approval in accordance with this procedure. After 3 years, the applicant may reapply for special approval for innovative medical devices in accordance with this procedure.

Article 11 The innovative medical device examination office shall define the category of medical device management at the time of reviewing the application for special approval for innovative medical devices. enterprise For applications, if the product is defined as a second type of medical device, the corresponding provincial drug regulatory authority may refer to this procedure for review and approval.

Article 12 For innovative medical devices that have been reviewed and approved in accordance with this procedure, the drug regulatory department at the place where the applicant is located shall appoint a person to communicate promptly and provide guidance at the request of the applicant. In the inspection of the applicant's quality management system, Should be given priority.

Article 13 In the case of innovative medical devices, the medical device inspection agency shall conduct a pre-evaluation of the product technical requirements submitted by the manufacturer in a timely manner, and provide timely feedback to the applicant.

Article 14 The medical device inspection agency shall give priority to inspection after receiving the sample and issue an inspection report. The pre-evaluated product technical requirements and pre-evaluation opinions shall be stamped with the same seal as the inspection report and issued together with the inspection report.

Article 15 The clinical trials of innovative medical devices shall be conducted in accordance with the requirements of the relevant provisions of the clinical trials of medical devices. The drug regulatory agency shall conduct supervision and inspections in accordance with the progress of clinical trials.

Article 16 The clinical research work of innovative medical devices requires major changes, such as the revision of clinical trial programs, methods of use, specifications and models, intended use, scope of application, or population adjustments, etc. Applicants should evaluate changes to the safety of medical devices. Impact of sexuality and quality controllability. Innovative medical devices whose main working principles or mechanisms of action have changed should 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 process of technical review, the device examination center shall appoint a special person to communicate promptly at the request of the applicant, provide guidance, and jointly discuss relevant technical issues.

Article 18 In the process of reviewing innovative medical devices, applicants may fill out an application form for communication and exchange of innovative medical devices and communicate with the Censoring Center on the following issues:

(i) Major technical issues;

(b) Major safety issues;

(c) clinical trial programs;

(iv) Summary and evaluation of the results of phased clinical trials;

(5) Other important issues that require communication and exchange.

Article 19 The equipment examination center shall promptly review the application for communication and related materials submitted by the applicant and inform the applicant of the results of the audit (see Annex 3). If the equipment examination center agrees to communicate, it shall clearly inform the applicant. The issues to be discussed, agree with the applicant on the form of communication, time, location, participants, etc., and arrange communication with the applicant. The communication should form a record, the record needs to be confirmed by the signature of both parties, for the follow-up study of the product and Review work reference.

Article 20 After accepting an application for registration of innovative medical devices, the Administrative Service Center of the State Food and Drug Administration shall mark the application for registration as 'innovative medical devices', and promptly conduct registration application data circulation.

Article 21 The equipment examination center shall give priority to technical review of innovative medical devices that have been registered for registration. After the completion of the technical review, the State Food and Drug Administration shall give priority to administrative examination and approval.

Article 22 The State Food and Drug Administration may terminate this procedure and notify the applicant if it falls under one of the following circumstances:

(a) The applicant has requested to terminate;

(b) The applicant failed to perform the corresponding obligations as required and required;

(c) The applicant provided forged and false information;

(d) The patent application for a core technology invention was rejected or deemed withdrawn.

(5) Loss of product patents for the invention of patents or right to use.

(6) The application product is no longer managed as a medical device.

(7) It is not appropriate to discuss the procedure after the review meeting of experts at the review meeting.

Article 23 The State Food and Drug Administration shall, in the course of implementing this procedure, strengthen communication and exchange with relevant departments and keep abreast of the progress in the research and development of innovative medical devices.

Article 24 If the approval of the licensing of registered medical devices is changed according to this procedure, the SFDA shall give priority to the application.

Article 25 Medical equipment required for emergency public health emergencies shall be handled in accordance with the "Emergency Approval Procedure for Medical Devices".

Article 26 The requirements and regulations for the registration of medical devices, if not covered by this procedure, shall be implemented in accordance with the relevant provisions of the Measures for the Administration of Registration of Medical Devices.

Article 27 Provinces, autonomous regions, municipalities directly under the Central Government drug The supervisory and administrative department may refer to this procedure to carry out special approvals for the second type of innovative medical devices within the administrative region.

Article 28 This procedure shall come into force on October 1, 2018. The “Special Approval Procedure for Innovative Medical Devices (Trial)” issued by the former State Food and Drug Administration on February 7, 2014 (Food and Drug Administration) 2014] No. 13) Repeal at the same time.