In order to give full play to the role in technical support of medical device testing organizations, earnestly carry out the pre-assessment on the standards of medical devices to be applied for registration, according to the "Interim Provisions on Further Strengthening and Regulating the Medical Device Registration", the National Bureau has recently organized the formulation of  the “Provisions for Medical Device testing organizations on Medical Device Standards Pre-assessment (Trial)”.

 

　　According to the provisions, medical device testing organizations should carry out pre-assessment on the standards of medical device products submitted to the testing organization for registration (hereinafter referred to as “product standards”). For product standards submitted by enterprises, medical device testing organizations should primarily evaluate from the following aspects: the existing mandatory national standards, completeness of referenced industry standards, suitability of referenced standards, and applicability of clauses in the standards; completeness of the referenced current recommended national standards and industry standards, suitability of referenced standards, and applicability of clauses in the standards; the completeness, suitability and applicability of the references in the content that involves the reference of Chinese pharmacopoeia; completeness and applicability of provisions referenced other than existing national standards and industry standards; the traceability of the test methods in the product standard, and the adaptability to the testing requirements.

 

　　Medical device testing organizations shall feed back their assessment results to the enterprise, and document the problems in the product standards finally confirmed and submitted by the enterprise in the “Feedback form of pre-evaluation on medical device standards to be applied for registration". For problems of product standards found during the registration test, if deeming it necessary, the testing organization may state it in the pre-evaluation feedback form.

 

　　In completing the pre-evaluation feedback form, the medical device testing organization should fill their comments in the corresponding columns based on different evaluation content, and provide a comprehensive evaluation opinion. The pre-evaluation feedback form and the pre-evaluated product standards should be stamped with the same seal and seal on the perforation as those on the test report, which will be issued together with the test report.