Enterprises engaged in online sales of medical devices|What conditions are needed

Enterprises engaged in online sales of medical devices|What conditions are needed for an enterprise to engage in online sales of medical devices?，What are the requirements? With the continuous advancement of "Internet +"，The integration of "Internet + medical devices" continues to accelerate，The use of the Internet to sell medical devices is becoming increasingly active。in recent years，To further reduce institutional barriers to e-commerce development，The country has successively introduced a series of policies。

but，Using the Internet to deceive consumers、The problem of selling counterfeit and substandard medical devices also continues to arise.。For example，On the online e-commerce platform、Directly operated websites or mobile clients illegally sell unregistered medical device products、Behaviors such as publishing illegal and illegal information frequently occur，Bringing potential risks to the safety of people using medical devices。

at the same time，Due to the virtual nature of online sales、Cross-regional characteristics，Resulting in unclear regulatory jurisdiction、Problems such as lagging regulatory measures。therefore，Improve regulations on online sales of medical devices，Clarify the main responsibilities of medical device online sales from the institutional level，standardize business conduct、It is of great significance to severely crack down on illegal sales of medical devices online。Accordingly，The State Food and Drug Administration has formulated the "Measures for the Supervision and Administration of Online Sales of Medical Devices"。

Enterprises engaged in online sales of medical devices，Medical device production licenses should be obtained in accordance with the law、Business license or filing，The sales conditions comply with the "Regulations on the Supervision and Administration of Medical Devices" and the "Measures on the Supervision and Administration of Online Sales of Medical Devices"

Require

，The operating model is to sell medical devices through self-built websites (including network client applications) or third-party platforms for medical device online trading services.。

also，Medical device network information services should be implemented in accordance with the "Internet Drug Information Service Management Measures"。therefore，Enterprises that engage in online sales of medical devices through self-built websites shall obtain an Internet Drug Information Service Qualification Certificate in accordance with the "Measures for the Administration of Internet Drug Information Services"。So，Enterprises engaged in online sales of medical devices，What conditions are needed? one、Filing。

Filing with the local district-level food and drug supervision and administration department，Relevant information changes，The filing information should be changed in a timely manner。two、Qualification、place、Technical conditions and management personnel

Require

。

Obtained the "Internet Drug Information Service Qualification Certificate" in accordance with the law，Have office space and data backup commensurate with its size、Technical conditions such as fault recovery，Set up a specialized medical device network quality and safety management organization or medical device quality and safety management personnel。three、Record。

Record medical device transaction information，Records should be kept until 2 years after the expiry date of the medical device；No validity period，The storage time shall not be less than 5 years；Implantable medical device transaction information should be permanently stored。technical measures should be taken，Ensure the authenticity and completeness of medical device online sales data and information、Safe and traceable。

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