China Makes Minor Updates to Medical Device Regulations for 2025
The Chinese State Council has released a small update to the Medical Device Supervision and Administration Regulations on January 7, 2025. This represents the third minor revision since its initial implementation in 2000.
The two specific changes include:
Administrative Authority Addition: Article 19, Paragraph 2 now includes both "the National Health Commission and the National Disease Prevention and Control Administration" as supervisory authorities, where previously only the National Health Commission was mentioned.
Terminology Update: Article 103 removes the reference to "family planning technical service institutions," reflecting modernized healthcare facility classifications.
The core framework of the regulations remains unchanged, continuing to:
- Ensure medical device safety and effectiveness
- Protect public health
- Support medical device industry development
These minor adjustments are part of a larger administrative cleanup by the State Council, which includes small modifications to 21 administrative regulations and the abolition of 4 others. The changes will take effect on January 20, 2025.
The limited scope of these amendments suggests continuity in China's medical device regulatory framework while making necessary administrative updates to align with current institutional structures.