BREAKING NEWS: CFDA Is Proposing 6 Major Changes to Its Medical Device Regulations


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CFDA just released a Solicitation for Public Comments (SPC) for its proposed amendment of the Medical Device Regulations (MDR), as mandated by a recent order from the Chinese State Council.

In this round of SPC, the CFDA proposes to add 8 items and revise 19 items in the MDR. Across the board, we find these proposed changes will impact these 6 areas of China’s medical device regulation policies and enforcement, namely:

  1. Improve the medical device Marketing Authorization Holder (MAH) system.
  2. Reform medical device clinical trials systems.
  3. Optimize registration and approval processes
  4. Improve regulation requirements for in-market products
  5. Strengthen the CFDA’s medical device management team across all administrative levels
  6. Bring responsibility penalties to specific individuals and parties after  violations of MDR policies.


China Med Device’s team advises our medtech companies to review the proposed changes and let us know your comments ASAP. From our analysis, we believe these proposed changes by CFDA will provide a more innovation-friendly medical device market for all manufacturers, both domestic and overseas.

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