I. The following documents are submitted to the SFDA for the products that have obtained the medical device registration certificate:
1. The "Medical Device Manufacturer License" (copy)
2. The medical device registration certificate (copy) for the exported products. Enterprise License" of the producer of the exported product (copy)
2, the medical device registration certificate of the exported product (copy)
3, the business license of the exporting enterprise (copy)
4, the applicant's self-assurance statement to ensure that the exported product meets the requirements of the regulations of the drug supervision and management authorities for the production and registration of the product, and that the submitted materials are true and legitimate.
A copy of the submitted certificate should be stamped with the official seal of the enterprise to which the certificate belongs.
Two, not obtained a medical device product registration certificate of the product, submit the following documents:
1, the manufacturer's business license (copy)
2, the business license of the exporting company (copy)
3, the applicant's self-assurance statement, to ensure that the submitted materials are true and legitimate.
A copy of the submitted certificate should be stamped with the official seal of the enterprise to which the certificate belongs.
The export certificate is relatively simple, after submitting the relevant documents, it will be quickly approved by the SFDA, and obtain the "People's Republic of China *** and the country of medical equipment products export sales certificate"