In China, the classification of medical devices is subject to continuous updates across Class I, II, and III. To regulate and standardize the regulatory consequences of these changes and guide enforcement by local authorities, the National Medical Products Administration (NMPA) published Announcement No. 52/2026, effective June 1, 2026.

The measure introduces a single procedural framework that does not modify device classification criteria but establishes binding rules on how administrative outcomes resulting from reclassifications must be managed.

The new provisions apply to the main regulatory transition scenarios:

• Devices already registered and marketed, defining the methods for adapting or updating registration in the event of a class change.
• Pending registration or renewal applications, for which the process may continue under the original class or be reallocated according to the new classification, with any specific notes on the certificate.
• Products change regulatory status, including cases where a device exists or enters the scope of medical devices.
• In vitro diagnostic (IVD) reagents, to which the same procedural framework applies.

For manufacturers operating in the Chinese market, the new framework has immediate impacts on product portfolio management and regulatory planning.

Why the measure was necessary

The Medical Device Classification Catalogue is frequently updated to reflect technological evolution and product-associated risk. However, the administrative consequences of classification changes have historically been managed inconsistently across different local authorities in China.

This enforcement heterogeneity created uncertainty for manufacturers, particularly foreign ones, complicating registration management and continuity of market access.

Announcement No. 52/2026 intervenes to introduce a coherent and binding system, aiming to standardize procedures and provide uniform guidance to provincial authorities in managing reclassifications.

Rules for managing transition phases

A core element of the measure concerns the management of transition phases between old and new classifications.

• Products already on the market: the Announcement establishes the methods for adapting registrations to the new class, including the management of the transition period and the validity limits of existing certificates.
• Pending registration or renewal applications: It clarifies when Authorities can proceed with evaluation under the original classification and when the dossier must be realigned with the new class. Upon approval, the new classification is indicated in the certificates or registration documents.
• Transitions between different regulatory regimes: The measure regulates cases of entry into or exit from the medical device scope, defining the administrative management of the transition.
• Registration certificate management: In specified cases, the holder must request the cancellation of the original certificate once the updated one is obtained; failing a voluntary request, the competent authority will proceed with ex officio cancellation.

Rules on production, marketing, and import

The Announcement stipulates that upon expiry of the transition period provided in individual classification adjustment documents, products non-compliant with the new classification can no longer be produced, marketed, or imported into China. There is no single, generally applicable deadline, as timelines are determined on a case-by-case basis by individual reclassification measures.

Extension to IVD reagents

The same rules apply fully to in vitro diagnostic reagents, confirming a harmonized regulatory approach between medical devices and IVDs during classification transition phases.

Impacts on foreign manufacturers

Overall, Announcement No. 52/2026 does not alter classification criteria but significantly impacts the administrative management of reclassifications.

For manufacturers exporting to China, this translates into greater nationwide application consistency, but also a stricter need for monitoring, timely registration updates, and accurate management of regulatory transition deadlines.

>>> Complife supports manufacturers in managing compliance for medical devices and IVDs, accompanying registration and update processes in China and major international markets, in line with local requirements and regulatory developments.

SOURCE:
NMPA Announcement No. 52/2026