Source: NMPA Finishing: Wheat

▲ NMPA released the "Working Procedures for Dynamic Adjustment of Medical Device Classification Catalogue (Draft for Comment)"(Source: NMPA)

On November 13, NMPA released the "Working Procedures for Dynamic Adjustment of Medical Device Classification Catalogue (Draft for Solicitation of Comments)", and publicly solicited opinions from the public. Enterprises, organizations or individuals with relevant opinions or suggestions can send their feedback to mdct@nmpa.gov.cn by e-mail before December 15, 2020, and the subject of the e-mail should indicate "Opinions on dynamic adjustment of medical device classification catalogues." ".

The "Working Procedures for Dynamic Adjustment of the Medical Device Classification Catalogue (Draft for Solicitation of Comments)" released this time aims to strengthen the management of medical device classification and standardize the dynamic adjustment of the "Medical Device Classification Catalogue".

Working procedures for dynamic adjustment of medical device classification catalog (draft for comments)

Article 1 [Purpose of Formulation] In order to strengthen the classification management of medical devices, standardize the dynamic adjustment of the "Medical Device Classification Catalogue" (hereinafter referred to as the "Classification Catalogue"), in accordance with the "Medical Device Supervision and Administration Regulations" and "Medical Device Classification Rules", this Work program.

Article 2 [Adjustment Principles] The dynamic adjustment of the "Category Catalog" should be based on changes in medical device risks, with reference to international experience, and follow the principles of conforming to the latest scientific knowledge, based on regulatory practices and promoting high-quality industrial development.

Article 3 [Types of Adjustments] Dynamic adjustments in the "Catalogue" include the following situations:

(1) Adjust the catalog framework;

(2) Adjusting the primary product category, secondary product category and management category;

(3) Adding typical medical devices;

(4) Delete products that are no longer managed as medical devices;

(5) Revise the content of product description, intended use and product name examples.

Article 4 [Methods for Proposal of Adjustments] Domestic medical device registrants and recorders, production and operation enterprises, and users may submit adjustment suggestions to the "Category Catalog" to the drug regulatory authority of the province (region, city) where they are located. The provincial (regional, municipal) drug regulatory department is responsible for the preliminary review of the adjustment proposal of the "Category Catalogue" within the administrative area. If it is deemed necessary to adjust, the adjustment proposal shall be submitted to the Medical Device Standard Management Center of the State Drug Administration (hereinafter referred to as the Standard Management Center) ).

Overseas medical device registrants and recorders can submit suggestions for adjustments to the "Category Catalog" to the Standards Management Center.

Article 5 [Methods for Proposing Suggestions by Other Related Parties] Relevant departments of the State Food and Drug Administration, provincial (regional, municipal) drug regulatory authorities, relevant social organizations, and members of the Medical Device Classification Technical Committee of the State Drug Administration (hereinafter referred to as the Classification Technical Committee) , You can propose adjustment suggestions for the "Category Catalog" to the Standards Management Center.

Article 6 [Requirements for Suggested Materials] The adjustment suggestions and related materials of the "Classification Catalog" shall be submitted through the classification and definition information system of the Standard Management Center. The related materials include but are not limited to the following:

(1) The content and reasons to be adjusted;

(2) Product management attributes, categories and industry status at home and abroad;

(3) The main product risk points and risk changes, etc.;

(4) Product technical features, comparison with similar products already on the market, and clinical use;

(5) Adverse product events and post-marketing supervision related information (if applicable).

Article 7 [Recommendation Review] The Standardization Management Center shall conduct research on the adjustment suggestions received from the Classification Catalog, analyze and evaluate the risk changes of the products, and form preliminary adjustment opinions.

Article 8 [Public Solicitation of Opinions] The Standard Management Center will publicly solicit opinions from the public on its website for the preliminary adjustment of the "Catalogue" for one month. According to the solicitation of opinions, the proposed adjustment opinions were revised and improved to form the "Classification Catalog".

Article 9 [Catalog Framework Adjustment] In response to the proposed adjustments to the catalog framework of the "Classified Catalog", the Standardization Management Center will submit the proposed adjustments to the State Food and Drug Administration, and the State Food and Drug Administration will publish it on the website of the State Food and Drug Administration 7 days after the procedure. Organize the Executive Committee of the Classification Technical Committee to review the proposed adjustment opinions of the "Classification Catalog", and publish the adjustment announcement in accordance with the procedures after the review is passed.

Article 10 [Adjustment of Other Contents] The proposed adjustment opinions of the "Category Catalogue" for other situations shall be submitted to the State Food and Drug Administration by the Standardization Administration Center. After 7 days of publication on the website of the State Food and Drug Administration in accordance with the procedures, the Standardization Administration Center shall organize the classification technology After the committee's professional group deliberated and passed the review, the standard management center will submit the adjustment opinions to the State Food and Drug Administration, and publish the adjustment announcement in accordance with the procedures.

Article 11 [Publication of Adjustment Opinions] The Standardization Management Center shall timely adjust the "Classification Catalog" database in accordance with the adjustment announcement of the "Classification Catalog" published by the State Drug Administration.

Article 12 [Frequency of Adjustment] The "Catalogue" shall be adjusted in a timely manner. In principle, the adjustment work shall not be less than once a year.

Article 13 [Registration requirements after category adjustment ] The registration/recording matters after the adjustment of the registered/recorded medical device category shall be implemented in accordance with the relevant requirements of the "Medical Device Registration Management Measures".

Article 14 [Applicability of In Vitro Diagnostic Reagents] The dynamic adjustment of the sub-category of in vitro diagnostic reagents shall be implemented with reference to this procedure.

Article 15 [Date of Implementation] This procedure shall be implemented from the date of publication.