The relevant materials required for the registration of passive medical device product samples are as follows:
(1) Inspection authorization letter/contract;
(2) Inspection samples (for imported samples, Chinese labels must be attached upon acceptance);
(3) Biological test plan;
(4) Product information (including product classification, component composition, material composition, specifications and models, structural diagrams, intended use, etc.);
(5) Authorization instructions/declaration (see attached document for details).
The above materials must be provided in stamped paper form. The inspection authorization letter can be downloaded from our website.
If the client requires separate biological reports to be issued in accordance with national and international standards, please specify this at the time of acceptance. In principle, no additional reports will be issued after acceptance unless new samples are submitted.
For any inquiries, please contact the Business Office by phone at 021-20590101.
Attachment:
https://www.sbrtc.com/uploads/20240906/8af0796741a08308c83a842c93e9e4be.docx
