The National Medical Products Administration (NMPA) of China has released comprehensive data on medical device standardization achievements for 2024, marking significant progress in both national and industry standards development.
At the national level, 49 standards were officially published, consisting of:
- 7 mandatory standards (14.3%)
- 40 recommendatory standards (81.6%)
- 2 technical guidance documents (4.1%)
In parallel, 90 industry standards were established, including:
- 15 mandatory standards (16.7%)
- 75 recommendatory standards (83.3%)
The year also saw substantial project initiation, with 33 new national standard projects and 100 industry standard projects launched, demonstrating China's continued commitment to enhancing its medical device regulatory framework.
This comprehensive standardization effort reflects China's strategic approach to medical device regulation, balancing strict quality control with market development needs.