China’s National Medical Products Administration (NMPA) has issued Announcement No. 52/2026, establishing a procedural framework to standardise the management of regulatory transitions resulting from medical device reclassifications.

• Application: The framework sets out transition procedures for products already on the market, pending registrations and renewals, and products entering or leaving the scope of medical device regulation.
• Enforcement: Products that do not comply with the new classification can no longer be manufactured, marketed or imported into China after the applicable transition period expires.
• Scope: The same procedural framework applies to in vitro diagnostic (IVD) reagents during classification transition phases.

This summary is based on a news article published by Complife Group.

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