NMPA issued the “Regulations on Self-test of Medical Device Registration (Draft)” on June 2, 2021, directing manufacturers on how to self-test and to submit the testing report.
Decree 739 Regulation on Supervision and Management of Medical Devices, announced on March 18, 2021, allows self-test report to replace the report submitted by authorized testing centers. It says that “testing report can be the self-test report of the medical device registration applicant or filing person, or the test report issued by a qualified medical device test agency”. In the Decree 680 issued in 2017, only Class I device can utilize self-test report.
How to Test & Submit
The document specifies the following five sections:
- Basic principles
- Requirements for self-test report
- Outsourcing requirements
- Application materials requirements
- On-site test requirements
In section 4, it includes:
- Self-test report
- Statement of Self-test Capability
- QMS related materials
- Statement of Authenticity of the Report
In section 5, it includes:
- Test record
- Quality control ability
- Inspector operation skills
- Qualification requirements for inspectors
- Facilities and environment
- Testing equipment
Takeaways for Overseas Manufactures
The document exempts certain requirements for imported devices:
- When submitting application materials, if the overseas manufacturer’s lab is accredited by the foreign government or other certified body, the Statement of Self-test Capability and QMS related materials can be exempted.
- When conducting on-site test, if the overseas manufacturer’s lab is accredited by the foreign government or other certified body, it can follow the on-site verification guidelines of China QMS.
For the detailed regulation please email info@ChinaMedDevice.com. We have test engineers to help you with gap analysis and expedite your type testing needs and shorten your renewal or new approval time.