About the third-party platform filing of medical device online transaction services

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  What is the third-party platform filing for medical device online transaction services According to "Order No. 38 of the State Food and Drug Administration" and "Measures for the Supervision and Administration of Medical Device Online Sales", it has been approved on November 7, 2017. It has been deliberated and approved by the executive meeting of the State Food and Drug Administration, and is hereby announced. It will come into force on March 1, 2018. The original "Internet Drug Trading License" is divided into three business models, namely the B2B third-party platform model (A license), the B2B model (B license), and the B2C model (C license). In 2017, its administrative approval items were cancelled successively. This year, it has been changed to the filing system, and it is divided into "Medical Device Network Operation Record" and "Drug Network Operation Record"

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  Classification of online transaction services for medical devices 1. Enterprises engaged in online sales of medical devices
  2. Third-party platform provider of medical device online transaction services
  Enterprises engaged in online sales of medical devices and third-party platform providers of medical device online transaction services shall abide by medical device regulations, rules and norms, establish and improve management systems, operate with integrity in accordance with the law, and ensure the quality and safety of medical devices.
  

Conditions for filing a third-party platform for medical device online transaction services

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  The third-party platform provider of medical device online trading services is to provide only web space, virtual trading venues, trading rules, trading matching, electronic orders and other trading services in the online trading of medical devices for two or more parties to carry out trading activities. , companies that do not directly participate in the sales of medical devices

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  Has obtained the "Internet Drug Information Service Qualification Certificate" according to law

Network trading service third-party platform system requirements

• It has the function of auditing and controlling the legality and validity of the enterprises, buyers and medical devices on the platform

• It has transaction management functions such as online ordering, payment and settlement, order circulation, transaction status query, evaluation and complaint, product return and exchange

• With the functions of medical device record browsing and product traceability, the product traceability function should be connected with the product traceability system in the local medical device business process

• With the function of generating, printing and saving sales records of sales receipts or return and exchange receipts

• With the function of quality announcement and related information release management

• Whether the third-party platform, website or network client application that conducts online wholesale and retail business of medical devices at the same time distinguishes between the wholesale login port and the retail login port

• On the product display page of the enterprise on the platform, whether to indicate the full name, province and detailed address of the selling enterprise.

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