Medical devices sold online need to apply for a medical device license.
Enterprises engaged in the online sale of medical devices, the main body of the application should be in accordance with the law to obtain a medical device production license, business license or for the record of the entity's medical device production and business enterprises and sales conditions in line with the "supervision and management of medical devices regulations" and "methods" requirements of the medical device listing license holder (i.e., medical device registrant or filer).
The mode of operation is to sell medical devices through self-built websites (including web client applications) or third-party platforms for medical device network transaction services.
Extended information:
Medical device network business scope shall not exceed the scope of its manufacturing license or the scope of the record. Medical device wholesale enterprises engaged in medical device network sales, should be sold to qualified medical device business enterprises or use units. Medical device retail enterprises engaged in medical device network sales, should be sold to individual consumers.
The sale of medical devices to individual consumers, should be available to consumers to use their own instructions should be in line with the relevant provisions of the medical device instructions and labeling management, labeling and safe use of special instructions. Should be a medical device used by medical institutions can not be sold to individuals.
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