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Food and Drug Administration issued new regulations for online sales of medical devices: offline stores should be

  • Release time:2022-06-19

【概要描述】

Food and Drug Administration issued new regulations for online sales of medical devices: offline stores should be

【概要描述】

  • 发布时间: 2022-06-19
详情

 

  Xinhua News Agency, Beijing, December 26 (Reporter Chen Cong) With the continuous upgrading of the concept of “Internet + medical care”, the integration of the medical device industry and the Internet has been accelerated, and the online sales of medical devices have become increasingly active. The problem of exaggerated propaganda and deceived consumers is also emerging. The State Food and Drug Administration recently issued the “Measures for the Supervision and Administration of Online Sales of Medical Devices”, which stipulates that offline enterprises engaged in online sales of medical devices should have the qualifications for medical device production and operation.

  The measures stipulate that enterprises engaged in online sales of medical devices shall conduct online sales of medical devices through self-built websites or third-party platforms for medical device online transaction services. An enterprise that conducts online sales of medical devices through its own website shall obtain the “Internet Drug Information Service Qualification Certificate” in accordance with the law, and have an office space suitable for its scale and technical conditions such as data backup and fault recovery.

  The person in charge of the relevant department of the CFDA said that the method adheres to the principle of consistency between online and offline, and specifies that the medical device production and operation enterprises and marketing license holders engaged in online sales should comply with the “Regulations on the Supervision and Administration of Medical Devices”. and the requirements of the Measures; third-party platform providers of online transaction services shall review and confirm the medical device production and operation qualifications of enterprises settled on their platforms.

  It is understood that this measure will come into force on March 1, 2018.

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