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Special Review Procedures For Innovative Medical Devices Issued By The State Food And Drug Administration

2022-03-28 Author: Views: 0

It is understood that the newly revised special review procedure for innovative medical devices has improved the application situation, refined the application process, improved the effectiveness of innovation review, improved the review methods and notification forms, and made it clear that changes in licensing matters of innovative medical devices should be handled first. The procedure setting is more scientific and effective, which is conducive to improving the review efficiency of innovative medical devices and playing a positive role in encouraging the innovation and development of medical device industry.

In order to implement the opinions of the general office of the CPC Central Committee and the general office of the State Council on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices (office Zi [2017] No. 42), encourage the R & D and innovation of medical devices, promote the promotion and application of new technologies of medical devices, and promote the high-quality development of the medical device industry, the State Drug Administration has organized and revised the special review procedure for innovative medical devices, which is hereby issued, Effective as of December 1, 2018. The special approval procedure for innovative medical devices (for Trial Implementation) (sdjxg [2014] No. 13) issued by the former State Food and drug administration shall be abolished at the same time.

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, these procedures are formulated in accordance with the regulations on the supervision and administration of medical devices, the administrative measures for the registration of medical devices, the administrative measures for the registration of in vitro diagnostic reagents and other laws and regulations.

(1) Through its leading technological innovation activities, the applicant owns the invention patent right of product core technology in China according to law, or obtains the invention patent right or its use right in China through assignment according to law. The application time for special examination of innovative medical devices shall not exceed 5 years from the date of patent authorization announcement; Or the application for a patent for invention of core technology has been made public by the Patent Administration Department of the State Council, and the patent search and consulting center of the State Intellectual Property Office has issued a search report, which indicates that the product's core technology scheme has novelty and creativity.

(3) The main working principle or action mechanism of the product is the first in China. The performance or safety of the product is fundamentally improved compared with similar products. It is at the international leading level in technology and has significant clinical application value.

Article 4 when applying for special examination of innovative medical devices, the applicant shall fill in the application form for special examination of innovative medical devices (see Appendix 1) before the first registration application of class II and class III medical devices, and submit the materials supporting the products to be applied to meet the requirements of Article 2 of these procedures. The information shall include:

(2) Product intellectual property and supporting documents.

(4) Product technical documents shall at least include:

2. Working principle or action mechanism of the product;

(5) The supporting documents of product innovation shall at least include:

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

(6) Product risk analysis data.

(8) Other materials proving that the product complies with Article 2 of these procedures.

An overseas applicant shall entrust an enterprise legal person in China as an agent or its office in China to file an application and submit the following documents:

2. Letter of commitment of the agent or the applicant's office in China;

The application materials shall be in Chinese. If the original text is in a foreign language, there shall be a Chinese translation.

An overseas applicant shall submit an application for special examination of innovative medical devices to the State Drug Administration.

For the accepted application for special examination of innovative medical devices, the applicant can apply to withdraw the application for special examination of innovative medical devices and relevant materials before the examination decision is made, and explain the reasons.

Article 8 after receiving the application for special examination of innovative medical devices, the innovative medical device examination office shall organize experts to conduct examination.

1. The application materials are false;

3. The contents of the application materials are obviously inconsistent with the application items;

5. The previous review opinion has clearly pointed out that the main working principle or action mechanism of the product is not domestic initiative, and the product design has not changed at the time of re application.

Article 10 after being examined by the innovative medical device examination office, for the application items to be specially examined, the applicant and product name shall be publicized on the website of the device examination center, and the publicity time shall not be less than 10 working days. If there is any objection to the publicity content, the final examination decision shall be made after studying the relevant opinions.

Within 5 years after the notification of the review results, the innovative medical devices that have not applied for registration will not be reviewed in accordance with this procedure. After 5 years, the applicant can reapply for special examination of innovative medical devices in accordance with this procedure.

Article 13 for the innovative medical devices that have been examined and approved to be examined according to this procedure, the provincial drug regulatory department where the applicant is located shall appoint a special person to communicate and provide guidance in time at the request of the applicant. After receiving the application for verification of the applicant's quality management system, priority shall be given to it.

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 drug regulatory department shall conduct supervision and inspection according to the process of clinical trials.

Article 17 for innovative medical devices, before accepting the application for product registration and during the technical review, the device Review Center shall designate special personnel to communicate and provide guidance in time at the request of the applicant and jointly discuss relevant technical issues.

(1) Major technical problems;

(3) Clinical trial protocol;

(5) Other important issues requiring communication.

Article 20 after accepting the registration application of innovative medical devices, the acceptance and Reporting Center shall mark the registration application item as "innovative medical devices" and transfer the registration application materials in time.

Article 22 under any of the following circumstances, the SDA may terminate this procedure and inform the applicant:

(2) The applicant fails to perform the corresponding obligations within the specified time and requirements;

(4) All core technology invention patent applications are rejected or deemed to be withdrawn;

(6) The applied product is no longer managed as a medical device;

Article 23 in the process of implementing these procedures, the SDA shall strengthen communication and exchange with relevant departments and timely understand the research and development progress of innovative medical devices.

Article 25 medical devices required for public health emergencies shall be handled in accordance with the emergency approval procedure for medical devices.

Article 27 the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government may carry out the special examination of class II innovative medical devices within their administrative regions with reference to these procedures.

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