021-51098737
Take care of every customer
Import medical equipment registration and The required documents :
Required Documents：
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Declaration of information first level title |
Declaration of information secondary title |
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Application Form |
Application Form for Overseas Registration |
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Proof of document |
Certificate of approval or approval of the product as a medical device to enter the country (region) market; certificate of qualification of medical equipment manufacturing enterprise |
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List of Safe and Effective Basic Requirements for Medical Devices |
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4. Summary information |
4.1 Overview |
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4.2 Product Description |
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4.3 Model specifications |
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4.4 Packing instructions |
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4.5 Scope of application and contraindications |
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4.6 reference to the same product or the previous generation of the product (if any) |
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4.7 Other explanations |
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5. Research material |
5.1 Product performance research |
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5.2 Biocompatibility Evaluation Study |
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Tel：021-51098737
Email：info@guide-cert.com
Address：Room 118，Building 20，No.83, North Hongxiang Road, Pudong District, Shanghai
