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1.Submission
data First submission (1) Application form for registration of medical devices produced within our national borders; (2) Qualification certificate of medical device production enterprise: Include a copy of production enterprise license, a copy of business license, as well as the applied product should be within the production contents checked and ratified in the production enterprise license; (3) Report on technology of the product: Should include at least the contents such as the definite basis required in technological indices or main specifications, and others; (4) Report on analysis of safety risks Compile and organize according to requirements in the standard of YY0316¡¶Risk analysis for medical devices¡·. Should include analysis on 5 aspects, namely, energy hazard, biological hazard, environmental hazard, hazard in related uses, and the hazards due to failure of functions, lack of careful maintenance or obsolescence and their corresponding preventive measures; (5) Applicable product standard and remarks: For those adopting national standard, professional standard as the applicable standard of their products, should submit the text of the adopted national standard or professional standard; registered product standard should be signed and stamped by the production enterprise. The production enterprise should submit a statement that the submitted product conforms to national standard or professional standard, and a statement that the production enterprise will undertake the quality responsibility after marketing, as well as remarks on the model and specification division of the product; (6) Self examination report on product specifications The items in self-examination on product specifications are the delivery inspection items defined in the registered product standard. It should include signatures of chief inspector or person in charge of chief inspection, and reviewer. For those adopting national standard, professional standard, and the production enterprise should supplement the self-determined delivery inspection items. (7) Product registration inspection report given by medical device inspection organization: For medical devices that need to perform clinical tests, inspection report given by medical device inspection organization within half year before starting clinical test should be submitted. For those need not to perform clinical test, inspection report given by medical device inspection organization within one year before acceptance for registration should be submitted. For those implementing Article 11, Article 12, Article 13 and Article 14 of this Method, the corresponding explanatory documents should be submitted; (8) Clinical test data for medical devices (For the ways of specific submission, please see the Appendix 12 of this Method); (9) Specification sheet of medical device; (10) Valid testimonial documents for examination of the product production quality system (certification)--- corresponding quality system examination report should be provided according to requirements of different products: a. System examination report within the date of validity, signed and stamped by Provincial, Autonomous region, or Municipal (under direct control) (Food) Drug administration; b. Inspection report on quality control norms for medical device production, or certificate of medical device quality system certification; c. For that the nation has already implemented the implementation detailed regulations for production, the check and acceptance report on implementing detailed regulations should be submitted; (11) Self-guarantee statement on reality of the data submitted: Should include a list of the data submitted, and a promise of the production enterprise to undertake legal responsibility. Registration Again |