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1、第二类医疗器械注册申报资料形式要求（Second types of medical equipment registration declaration form requirements）Second types of medical equipment registration declaration form requirementsI. When an enterprise submits written materials for registration, it shall simultaneously make an electronic declaration. Electro
2、nic reporting procedures and requirements, please login provincial government website download equipment production credit operation manual ( :/ zjfda.gov /download/index.jsp). When accepting the written registration application submitted by the enterprise, the recipient shall accept it online at th
3、e same time.Two, corporate filings in the registration (including the first registration, re registration, to change the standard request and the specification for the record), electronic text should be submitted at the same time the product registration standard and specification (Word format), its
4、 content must be in agreement with the paper. Direct adoption of national standards or industry standards as a product registration standard, may not submit the product registration standard electronic text. When submitting the application for the first registration of medical devices, the enterpris
5、e shall provide the registration verification report together.Three, the application of materials in the same project should be completed in accordance with. Application materials should be printed in A4 specification paper, and documents issued by government and other organizations shall be provide
6、d in the original (copy) size. The application materials shall be clear and neat, each application materials shall be affixed with the seal, and unified with the pumping rod clip in accordance with the order of binding application materials, the data should be separated by every page with the label,
7、 and indicate the data item number. The application for registration shall be made in two originals, one of which is original.For the product structure is complex, the use mechanism is not clear, and the first listing of products in the province to request the application materials in five copies.Ba
8、sic requirements for registration and declaration of second types of medical devicesI. Basic requirements for the first registration of declaration materials(1) application form for registration of medical device products (see Schedule 1, fill out and print from the administrative examination and ap
9、proval system, see the following picture in format)The application form shall be signed by the legal representative and stamped with the official seal. The items to be filled out shall be complete and accurate, and the contents shall be in accordance with the following requirements:1, production ent
10、erprise name, registered address and industrial and commercial business license is exactly the same.2, product name, specification model and the submitted product standards, inspection reports and other application materials used in the name, specification, model is exactly the same.(two) medical eq
11、uipment manufacturing enterprise qualification certificate;Including copies of the copy of the medical device manufacturing enterprise license and copies of the business license. Applications for registration of products shall be within the scope of production approved by the medical device manufact
12、uring enterprise license. The medical device manufacturing enterprise license and the industrial and commercial business license are all in the period of validity.(three) product technical report;The product technical report shall contain at least the following:1, product features, working principle
13、, structure, and intended use;2, technical indicators or main performance indicators to determine the basis;3, product design control, development, development process;4, the main process and description of the product;5, product testing and clinical trials;6, compared with similar products at home
14、and abroad.(four) safety risk analysis reportSafety risk analysis report shall at least include energy hazards, biological hazards, environmental hazards, hazards related to the use of and by failure, maintenance weeks or aging hazard analysis, and other aspects of the risk caused by the risk contro
15、l and prevention measures etc.(five) the implementation of standard products and preparation instructions (except for registration two registered product standards in the data, the other must submit a separate registration standard text for review, and the accompanying medical register standardcheck
16、 questionnaires three copies)The standard form of the product submitted by the enterprise can be divided into three kinds: the national standard, the industry standard or the registered product standard text.1, the national standards and industry standards for product standards, should be effective and practical text submitted to the national standards or industry standards
