ISSUING AUTHORITY:

National Medical Products Administration

DATE OF ISSUANCE:

June 1, 2026

EFFECTIVE DATE:

June 1, 2026

The NMPA issued Announcement No. 52 of 2026 to establish comprehensive procedural rules governing adjustments to the classification or management attributes of medical devices. The Announcement applies to products already on the market and pending applications, setting out requirements across seven core scenarios, including the validity of existing certificates, initial registration, renewal registration, change of registration or filing, conversion between filing and registration, amendment to product filing, and post-adjustment production, distribution and importation.

The rules differentiate between upward and downward classification adjustments, prescribing distinct renewal, re-registration and cancellation pathways. For products newly brought within or removed from the medical device regulatory scope, the Announcement specifies corresponding registration, filing or de-registration obligations, and clarifies that pending applications for products no longer regulated as medical devices shall be terminated and the application materials archived for reference. Where adjustment documents contain specific provisions on registration or filing, such provisions shall apply. Where a transition period is provided, registrants and filing entities must proactively complete the necessary procedures and fulfill their primary responsibility for product quality and safety throughout the product lifecycle. Provincial drug regulatory authorities are required to establish product management ledgers, strengthen supervision and guidance, and oversee compliance by registrants and relevant enterprises.

Reference:

国家药监局关于医疗器械分类调整有关工作的公告（2026年第52号）