On October 22, 2021, the NMPA (National Medical Products Administration) published (No.126-2021) the Regulations on Self-test of Medical Device Registration.
The first draft of the self-test regulation was released days after the launch of the Order 739 where it was officially introduced, and later on, the NMPA solicited for public comments on the revised draft in July 2021.
Following our detailed review of the regulations, our current view is that it is nearly impossible for importing manufacturers to fulfil the requirements for self-test because the foreign manufacturer has to do the tests strictly according to Chinese standards. So for our customers we continue to recommend from a risk, timing and cost perspective to undertake sample testing with NMPA certified test labs in China.
- The NMPA can accept self-testing reports that are issued by self-owned laboratories of applicants in support of medical device registration in China.
- The NMPA can accept a combination of self-testing reports issued by a self-owned laboratory of the applicant, and other laboratories appointed by the applicant. However, the laboratory appointed by the applicant needs to have a CMA qualification certificate.
- The NMPA can accept self-testing reports that are all from other laboratories appointed by the applicant. However, the laboratory appointed by the applicant needs to have a CMA (China Inspection Body and Laboratory Mandatory Approval) qualification certificate.
- When submitting the self-testing report, the self-testing capability declaration statement and QMS (quality management system) related supporting documents can be exempted if:
- The self-testing report submitted by domestic applicants is issued by a self-owned laboratory with CNAS (China National Accreditation Service for Conformity Assessment) accreditation; or
- The self-testing report submitted by foreign applicants is issued by a self-owned laboratory with approval from the applicant’s government.
As a supporting regulation to Order 739, the finalized regulation requires the medical device registration applicants or filing persons to incorporate self-testing into the medical device quality management system, and possess self-testing capabilities in terms of staff, equipment, sample management, quality and record control. Inspectors, test laboratories, manufacturing subcontractors and corporate groups are also obliged to meet the self-testing requirements.
By Alice Liu and Jacky Li. Contact Cisema if you would like to learn more.