The Food And Drug Administration Has Issued New Regulations On Online Sales Of Medical Devices: Offline Physical Stores Should Be Available
As the concept of "Internet + medical grows, medical equipment industry and Internet integration accelerating, medical equipment sales network has become increasingly active, but using the Internet selling fake and inferior equipment, false exaggerated propaganda, consumer fraud problems also appear constantly.State food and drug supervision and management of administration released by the measures for the supervision and administration of medical device sales network and regulations, engaged in medical equipment sales network of enterprises offline should have medical equipment production and business operation qualifications.
The measures stipulate that enterprises engaged in network sales of medical devices shall carry out network sales activities of medical devices through self-established websites or third-party platforms for network trading services of medical devices.Through self-built website to carry out the network of medical equipment sales of enterprises, shall be in accordance with the "Internet drug information service qualification certificate", and have corresponding to the scale of its offices and the data backup and recovery technology conditions
Food, head of the administration of drug safety related departments, to adhere to the principle of online consistent, clear medical equipment production and operation enterprises engaged in online sales and marketing authorisation holder, the conditions of sale shall conform to the regulations on the supervision and administration of medical devices and the system requirements;Third party platform providers of online trading services shall verify and confirm the production and operation qualifications of medical devices of enterprises stationed on their platforms.
It is understood that the measures will come into effect on March 1, 2018.