On May 8, the National Medical Products Administration (NMPA) issued the Announcement on Issuing the Working Procedure for Dynamic Adjustment of the Medical Device Classification Catalogue. Source: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210508151135154.html
According to the announcement, NMPA has formulated the Working Procedure for Dynamic Adjustment of the Medical Device Classification Catalogue for adjustments to the Medical Device Classification Catalogue.
This working procedure is formulated to strengthen medical device classification administration and standardize dynamic adjustments to the Medical Device Classification Catalogue (hereinafter referred to as the Classification Catalogue), in accordance with the Regulations on the Supervision and Administration of Medical Devices and the Rules for Medical Device Classification.
Dynamic adjustments to the Classification Catalogue cover the following scenarios: (1) Adjustment of sub‑catalogues; (2) Adjustment of primary product categories, secondary product categories and/or management classes; (3) Addition of representative innovative medical device products; (4) Deletion of products no longer regulated as medical devices; (5) Revision of product descriptions, intended uses, nomenclature examples and other contents.
Domestic medical device registrants and filers, manufacturing & trading enterprises and user institutions may submit proposals for adjustment to the Classification Catalogue to the drug regulatory department of their respective province (autonomous region or municipality directly under the Central Government). Overseas medical device registrants and filers may entrust their domestic agents to submit adjustment proposals to the drug regulatory department where such domestic agents are located.
Provincial drug regulatory departments shall conduct preliminary reviews on adjustment proposals within their jurisdictions. Where an adjustment is deemed necessary, the proposal shall be submitted to the NMPA Center for Medical Device Standards Management (hereinafter referred to as the Standards Management Center).
Relevant departments of NMPA, provincial drug regulatory authorities, relevant medical‑device‑related academic societies, associations and other social organizations, as well as members of the NMPA Medical Device Classification Technical Committee, may submit adjustment proposals to the Standards Management Center.
Proposals for adjustment to the Classification Catalogue and supporting documents shall be submitted via the Classification Definition Information System operated by the Standards Management Center. Submission materials include, but are not limited to: (1) Proposed adjustment contents and justifications; (2) Domestic and overseas regulatory attributes, classification and industrial status of the products subject to proposed adjustment; (3) Major risk points and risk variations of the products subject to proposed adjustment; (4) Technical features of the products subject to proposed adjustment, comparisons with marketed peer products and clinical application status; (5) Adverse events and post‑market supervision information of the products subject to proposed adjustment (if applicable).
Registration and filing matters for medical devices whose management class has been adjusted shall be handled in compliance with the Provisions for Medical Device Registration and Filing and other relevant requirements.
Adjustments to the Classification Catalogue shall be conducted as needed, with no less than one adjustment round in principle each year.
Dynamic adjustments to the sub‑catalogue for in‑vitro diagnostic reagents shall be implemented with reference to this procedure.
This procedure shall take effect on the date of promulgation.
