Net sales of new medical equipment regulations | online businesses need to go offline stores

December 22, the State Food and Drug Administration (hereinafter referred to as 'Food and Drug Administration') released in the official website of the 'medical device network sales supervision and management approach' ( Hereinafter referred to as the "approach") pointed out that it will adhere to the principle of online and offline consistency, requiring online trading service platform for third-party platform to review the business opportunities required to require online sales of medical equipment businesses need to have a physical store offline.

It is reported that "Measures" was reviewed and approved by the Bureau of Food and Drug Administration's Executive Council on November 7, 2017 and will come into force on March 1, 2018. The Measures state that, medical instruments Network trading services third-party platform providers, should apply for landing platform enterprise Provide medical equipment production and operation license or record voucher, medical device registration certificate or record voucher, enterprise business license and other materials to verify, establish files and update in time, to ensure that the platform for entry into the enterprise license or record voucher set out in the production and operation Site or other permits or filing information is true.This also means that the third party network transaction service platform providers should review and confirm the presence of enterprises in the platform with offline physical store qualification.

In fact, the net market for medical devices is not only strictly regulated by the government, but also indispensable to the self-discipline of the industry.Article 6 of the Measures stipulates that enterprises engaged in the sales of medical devices and networks, third-party platforms for medical device network transaction services Providers should actively cooperate with food drug Supervision and administration departments shall conduct supervision and administration over network monitoring, sampling and site inspection, store the data in accordance with the requirements of the food and drug supervision and administration department, and provide related support such as information inquiry and data extraction.