China: NMPA Updates Medical Device Classification Catalog

On 5 September 2025, the National Medical Products Administration (NMPA) announced an update to the Medical Device Classification Catalog, refining product categories and regulatory requirements. This update reflects China’s continued efforts to strengthen oversight, improve regulatory clarity, and align classification with evolving medical technologies.

The revised catalog includes adjustments in device categories, risk levels, and descriptions. By clarifying definitions and updating classifications, the NMPA aims to improve consistency in product registration and streamline review processes. Manufacturers will benefit from clearer pathways when determining submission requirements, while regulators can ensure more efficient and accurate evaluations.

For medical device companies, this update means re-examining existing and planned registrations to confirm alignment with the new classifications. Products previously classified under one category may now shift into another, potentially impacting regulatory timelines, documentation needs, and compliance strategies. Early review of these changes will be crucial for avoiding delays in market entry.

This update is also a sign of China’s broader regulatory modernization. By refining the classification framework, the NMPA is paving the way for better resource allocation during reviews, a stronger emphasis on patient safety, and a more transparent regulatory environment. It also signals to global stakeholders that China continues to build a regulatory system aligned with international standards.

Overall, the revised classification catalog represents an important milestone for both regulators and the medical device industry. Companies operating in China should carefully analyze the changes, reassess their portfolios, and prepare for potential adjustments in submission requirements.

Source: National Medical Products Administration (NMPA), China