According to the “Administrative Measures for Registration and Filing of Medical Devices” and “Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents”, the medical device testing report can be applicant’s self-testing report or can be that issued by a qualified testing agency.
There are three circumstances: self-testing of the entire project, self-testing + entrusted testing, and entrusted testing of the entire project.
For the self-testing of the entire project and the self-testing + entrusted testing
The testing and registration shall be carried out in accordance with the Part 4. Requirements of Application Materials of “Regulations on the Self-testing of Medical Device Registration”.
For the entrusted testing of the entire project
The testing should be carried out with reference to the Part 3. Requirements for Entrusted Testing of “Regulations on the Administration of Self-testing of Medical Device Registration” and the following materials should be submitted:
- Testing report issued by a qualified testing institution
- If an overseas registration applicant entrusts an agent in China to handle the testing, it shall state that the agent is “entrust a qualified agent to conduct the testing in China, based on the product technical requirements”, and the corresponding content shall be stated in the agent’s commitment letter
- The above information should be signed and sealed by the applicant or agent, and the document format should comply with the “Announcement of Medical Device Registration Application Materials Requirements and Approval Document Format” Annex 4 and “Announcement of In Vitro Diagnostics Registration Application Materials Requirements and Approval Document Format” Annex 3.