MEDTECH NEWS
China NMPA Issues Announcement on Medical Device Classification Adjustment Procedures
11 06 2026China's National Medical Products Administration (NMPA) issued Announcement No. 52 (2026) on June 1, 2026, establishing comprehensive procedural requirements for the registration and filing of medical devices — including in vitro diagnostic reagents — following regulatory classification adjustments. The announcement addresses a broad range of scenarios, including first-time registration, renewal, product changes, and transitions between filing and registration categories, while setting clear deadlines and responsibilities for both manufacturers and regulatory authorities. Products that fail to obtain valid registration or complete required filings before the applicable transition deadline will be prohibited from manufacture, distribution, and import. The announcement took effect immediately upon publication.
China Tightens Medical Device Classification Rules to Enhance Safety and Efficiency
16 05 2024The National Medical Products Administration has issued Announcement No. 59 of 2024 to improve the classification management of medical devices. The announcement details the procedures for classifying medical devices based on regulations and guidelines, focusing on factors like intended use and risks. It covers classification for new devices, uncertain categories, and emergency situations during public health crises. The implementation begins on September 1, 2024, replacing the previous classification notification.