The directive Principle of Registration Declaration for Overseas Non-power-driven And Implantable Medical Devices
1.Technical supporting documents(applicable for the product’s first registration ) To get a scientific and reasonable evaluation of product declared registration regarding the safety and effectiveness, and to meet the requirements of technical evaluation, the applicant/manufacture should provide the technical supporting documents (refer to the concrete requirement in technical reports of declaration for product registration in Territory) submitted to obtain the oversea sales’ permit for the first registration of non-power driven and implantable medical device, as an attachment of approval files for overseas’ sale permit. The technical document should be issued by the oversea product’s manufacture. 2．Product registration standard
(1) According to Regulation of medical devices (on trial), the product registration standards must be in compliance with national standard, industry standards, also relevant laws and regulations. Based on this, manufactured should provide the techniques with quality control, safety and efficiency, according to the features of the product. Technical requirements and testing methods should all be verified in Product registration standard. (2) Product registration standard contains the main body and description for drawing up. The description for drawing up should contain following contents: ① the use history of material contacted with human body in clinical trial, and the validation of its safety and credibility; ② relevant standard and document cited or referred ; ③ Basis for determination of category management ;
④ Product description and basis of determination of main technical articles ; ⑤ Other contents need to be illustrated.
(3) In Product registration standard, the composition of raw material and each component used in product should be instructed clearly, confirm the name of materials if they have; demonstrate the product with corresponding structure and schematic drawing, and detailed product dimension. (4) About the Product registration standard regarding the re-registration of product, if the manufacture revises on basis of original version, when declare the re-registration of product, manufacture should provide instruction of standard revision, in which the content modified and the basis of revision should be definite. For some re-registration product, whose product design and sphere of application have not change, but become one part of Product registration standard due to the citation of Product registration standard in national/ industry standards, the Product registration standard needs to be updated correspondingly with the national/ industry standards renovating. (5) During the declaration of registration, if the applicant/manufacture revised the content of Product registration standard and submitted a new version, the comparison documents before and after the revision of standard should be provided when supplies the documents listed on advice note of document supplement. 3．Clinical trial reports
(1) Provide clinical trial report according to Clinical trial regulation of medical devices, if the oversea product declared registration is required a clinical trial in China. (2) Clinical trial protocol
① The clinical trial protocol should confirm clearly the evaluation index of therapeutic effect, and uses an internationally accepted evaluation standard, if there’s no official standard, uses the evaluation standard of clinical routine therapeutic effect. ② In the clinical trial protocol, the number of trial sample should be confirmed on the basis of trial purposes, trial types (excellent efficiency, non-inferiority, equivalent), and meet the scientific requirements. Use the classical, accepted calculation method, calculation formula, and statistical software (like SAS, SPSS, SYS, TAT) ③ To get a scientific and effective...
References: 1．Supervision regulation of medical devices(No.276 The Law of State Department of People’s Republic of China), 200.1.4.
2. Registration Management of Medical Devices (Administrative law No.16), 2004.8.9
3. Clinical trial regulation of medical devices（Administrative law No.5）,2004.1.17
4. Regulation of medical devices(on trial)（Administrative law No.31）,2002.1.4
5. Regulation of medical devices’specification,label and packaging（Administrative law No.10）,2004.7.8
6. Standards for registration declaration of Class III medical device in Territory and oversea medical device [CFDA (2005) No.111]
7. Biomedical Material, Yaoting Yu, Tianjin University Press 2000.12
8. Biomedical Material, Yubao Li, Chemical industry Press 2003.8
9. Basic Technic Directive principle of Research for Chemical pharmaceutical [CFDA 2005) No.106]2005.3
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