China NMPA Issues Announcement on Medical Device Classification Adjustment Procedures
BEIJING, June 1, 2026 — China's National Medical Products Administration (NMPA) has published Announcement No. 52 (2026), outlining comprehensive procedural requirements governing the registration and filing of medical devices — including in vitro diagnostic reagents (IVDs) — following adjustments to their regulatory classification. The announcement took effect immediately upon issuance on May 29, 2026.
Background
The announcement was issued in accordance with China's Regulations on the Supervision and Administration of Medical Devices, the Measures for the Registration and Filing of Medical Devices, and the Measures for the Registration and Filing of In Vitro Diagnostic Reagents. It aims to provide clear operational guidance for manufacturers, registrants, and regulators when a product's management category or regulatory status is reclassified.
Key Provisions
Registration and Filing After Classification Adjustment
From the date a classification adjustment takes effect, all new registration applications must be submitted under the revised category. Applications already accepted prior to the adjustment date may continue to be reviewed under the original category; if approved, the updated classification will be noted in the registration certificate's remarks column. Renewal applications pending at the time of a classification adjustment may likewise proceed under the original category. For products downgraded to a lower class, registrants must apply for renewal or filing under the new classification upon expiry. For products upgraded to a higher class, the original registration certificate remains valid within its approved term but must not exceed any transition deadline specified in the reclassification document.
Once a registrant obtains a registration certificate under the new classification, they are required to proactively apply for cancellation of the original certificate. Failure to do so will result in the original registration authority initiating cancellation procedures. Products requiring registration changes or filing updates must submit applications to the original registration authority, which will issue revised documents noting the updated classification in the remarks column. Products reclassified downward to Class I may be filed under the new category from the adjustment date onward, while those reclassified upward from Class I must apply for registration under the new class and proactively cancel their existing Class I filing. From the expiry of the applicable transition period, products without valid registration or Class I filing are prohibited from being manufactured, distributed, or imported.
Products Newly Brought Under Medical Device Regulation
Products previously not regulated as medical devices but reclassified as such must obtain registration or complete Class I filing with the appropriate regulatory authority. Manufacturing, distribution, and importation are prohibited after the transition deadline without valid authorization.
Products Removed from Medical Device Regulation
Products reclassified as non-medical devices are no longer subject to medical device oversight from the date the adjustment takes effect. Pending registration applications will be terminated, and all related materials will be archived for reference.
Additional Requirements
Where specific reclassification documents contain special provisions, those provisions take precedence over the general requirements set out in this announcement. During any applicable transition period, registrants and filing holders must actively pursue compliance and maintain full responsibility for product quality and safety throughout the product lifecycle. Provincial-level drug regulatory authorities are required to establish product management ledgers for reclassified products within their jurisdictions and to supervise and guide companies accordingly.
Significance
The announcement provides a unified, structured framework for handling the regulatory transition of medical devices undergoing classification changes — an area that has historically presented procedural ambiguities for both industry and regulators. The guidance is expected to bring greater consistency and predictability to China's medical device registration system.