Self-testing Vs. Type-testing In China


When using self-testing report to replace a type testing report, the following requirements need to be considered:

  1. Make sure that the self-testing report refers to the current Chinese standards that are acceptable by the NMPA
  2. The lab where the self-testing will be conducted should possess the corresponding qualifications, tools, and personnel per NMPA requirements and guidelines.
  3. On July 23, 2021, the China NMPA issued the further modified draft guidance on the Self-testing of Medical Devices for China Registration based on previous comments collected from the public. NMPA is now releasing the second draft guidance for public opinions. The final version of the guidance has not been released yet.

Takeaway: It is recommended to perform self-testing at your local laboratories with the help of consultants who are experts in running type-testing in China. There are a lot of details to consider making sure your self-testing reports are compliant with NMPA requirements.