The directive Rule of Registration Declaration to get Overseas Non-power-driven And Implantable Medical Gadgets
1 . Technical supporting documents(applicable for the product's 1st registration ) To get a medical and reasonable evaluation of product announced registration regarding the safety and effectiveness, and meet the requirements of technical evaluation, the applicant/manufacture ought to provide the technical supporting papers (refer for the concrete requirement in technical reports of declaration for product registration in Territory) submitted to obtain the oversea sales' permit to get the 1st registration of non-power driven and implantable medical system, as a great attachment of approval data files for overseas' sale allow. The specialized document must be issued by oversea product's manufacture. 2．Product registration regular
(1) According to Regulation of medical devices (on trial), the item registration criteria must be in compliance with national standard, industry specifications, also relevant laws and regulations. Based upon this, produced should give the techniques with quality control, safety and efficiency, based on the features of the product. Technical requirements and assessment methods should all be tested in Merchandise registration standard. (2) Item registration regular contains the primary body and description for drawing up. The description pertaining to drawing up will need to contain following contents: � the use history of material contacted with human body in specialized medical trial, and the validation of its basic safety and trustworthiness; ② relevant standard and document cited or referenced; ③ Basis for perseverance of category management;
④ Item description and basis of perseverance of main technical content; ⑤ Various other contents have to be illustrated.
(3) In Item registration common, the formula of organic material and component found in product should be instructed obviously, confirm the identity of supplies if they may have; demonstrate the item with corresponding structure and schematic pulling, and in depth product aspect. (4) Regarding the Product enrollment standard about the re-registration of product, in case the manufacture revises on basis of original version, when file the re-registration of merchandise, manufacture ought to provide instructions of common revision, where the content modified and the basis of revision ought to be definite. For some re-registration item, whose product design and sphere of application haven�t change, nevertheless become a single part of Item registration normal due to the quotation of Product registration regular in national/ industry requirements, the Product registration standard needs to be updated correspondingly with the national/ industry criteria renovating. (5) During the announcement of enrollment, if the applicant/manufacture revised this article of Merchandise registration normal and submitted a new edition, the evaluation documents after and before the version of common should be provided when offers the documents outlined on advice note of document health supplement. 3．Clinical trial reports
(1) Give clinical trial report in respect to Specialized medical trial dangerous medical equipment, if the oversea product declared registration is necessary a clinical trial in China. (2) Clinical trial protocol
� The clinical trial protocol should confirm clearly the evaluation index of therapeutic result, and uses an internationally accepted evaluation standard, if there's no recognized standard, uses the analysis standard of clinical routine therapeutic impact. ② Inside the clinical trial protocol, the amount of trial sample should be confirmed on the basis of trial purposes, trial types (excellent efficiency, non-inferiority, equivalent), and meet the technological requirements. Make use of the classical, recognized calculation technique, calculation method, and statistical software (such SAS, SPSS, SYS, TAT) ③ To acquire a scientific and effective...
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2 . Registration Administration of Medical Devices (Administrative law Number 16), 2005. 8. on the lookout for
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4. Regulation of medical devices(on trial)（Administrative rules No . 31）, 2002. 1 ) 4
a few. Regulation of medical devices'specification, packaging and packaging（Administrative law No . 10）, 2005. 7. 8
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7. Biomedical Material, Yaoting Yu, Tianjin School Press 2000. 12
almost 8. Biomedical Material, Yubao Li, Chemical market Press the year 2003. 8
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