As required by Regulations for the Supervision and Administration of Medical Devices,Measures for the Supervision and Administration of Online Sales of Medical Devices,enterprises engaged in the online sales of medical devices shall be medical device production and operation enterprises that have obtained medical device production licenses, business licenses, or filing credential in accordance with the law.Except where the laws and regulations do not require permission or filing.An enterprise engaged in online sales of medical devices shall apply for a filing credential for online sales of medical devices.
If an enterprise engaged in online sales of medical devices fails to file as required, the local drug regulatory department at or above the county level shall order it to make corrections within a time limit and give a warning; if it refuses to make corrections, it shall announce to the public and impose a fine of less than 10,000 yuan.
C.Documents Provided by Client
1.Copy of business license.
2.Explanation of non-operating internet information services(for self-built website).
3.Telecom Business License (for self-built website)
4.Copies of Medical Device Registration Certificate/Filing Credential,Medical Device Production License,Medical Device Distribution License or Medical Device Distribution Filing Credential.
D.Professional Services from ZOOP
ZOOP will provide professional filing services for online sales of medical devices.
Estimated filing period for online sales of medical device:0.5-1 month.