Self-Test Report Applicable for Class II and III Devices Now – Here is How to Test


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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:

  1. Basic principles
  2. Requirements for self-test report
  3. Outsourcing requirements
  4. Application materials requirements
  5. 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:

  1. 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.
  2. 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 We have test engineers to help you with gap analysis and expedite your type testing needs and shorten your renewal or new approval time.

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