Class I medical devices filling
- PRODUCT DETAIL
Class I Device: Class I medical devices no longer need to be registered with the CFDA; instead, a notification must be filed with the relevant local level Chinese FDA. However, for the notification application, more documents will be required than there were for Class I registration.
Class I Device
1.Product Risk Analysis Document
2.Product Technical Specification
3.Product Testing Report (company’s self-testing report or 3rd party report)
4.Clinical Evaluation Report
5.Key Manufacturing Information (process, flowchart, material, etc.)
6.Design/artwork of IFU and product label for the minimum selling unit
Legal qualification of the foreign manufacturer (i.e. ISO 13485)
Market authorization approval at the country of origin (i.e. CFG+510k or CE)
Authorization letter to the agent in China.
Letter to declare that the documents submitted meets the CFDA’s regulation for Class I Medical device notification.
Letter to declare that the product conforms to the Class I Medical Device classification catalog.
Letter to declare that the product conforms to the National and/or Industry standards (GB/YY) in China, and the list of these conformed standards.
Letter to declare that all submitted documents are true.
Please note that for all documents sent to the CFDA, the applicant should provide the Chinese translation as well. For the legal documents listed below, the applicant should submit the original or a notified copy.