Medical Device Registration Measures, Article 7 provides that "application for registration of medical devices, there should be applicable product standards, you can use national standards, industry standards or the development of registered product standards, but the registered product standards shall not be lower than the national standards or industry standards". Article 45 of the Measures for the Supervision and Administration of Medical Device Production stipulates that "medical devices produced by medical device manufacturers shall comply with national standards, industry standards and registered product standards. Medical devices listed for sale shall be tested and qualified, and accompanied by a certificate of conformity". Article 15 of the Regulations also provides that "the production of medical devices shall comply with national standards for medical devices; where there are no national standards, they shall comply with industry standards for medical devices". From these regulations can be seen, the certificate of conformity is based on the registration of the approved standards issued by the qualified test certificate, that is, its test is based on the medical device product registration certificate of the product standard column marked in the standard.
Consult your local medical management department for details.