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 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.

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