Key Takeaways from CFDA’s “Medical Devices Online Sales Supervision and Management Measures”

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As planned, CFDA is to enforce its “Medical Devices Online Sales Supervision and Management Measures” on March 1st, 2018 that governs online sales of all medical devices in China.  

Here are some key points we have learned:

Clear differentiation between “enterprises engaged in the sales of medical device networks” and “providers of third-party platform for medical device network transaction services”

The Measures stipulate the principle of “online and offline consistency”. Enterprises engaged in online sales of medical devices shall have the body of the medical entity that has obtained the medical device manufacturing license, the business license or the record-keeping entity and the sales conditions conforming to the requirements Medical Device Licensing Holders (ie, medical device registrants or fillers) required by the Regulations and the Regulations of the Medical Device Administration shall operate through self-built websites (including web client applications) or medical device networks Third-party trading services platform for sales of medical equipment.

 

Third-party platform provider of medical device network transaction service refers to providing transaction services such as web space, virtual transaction sites, trading rules, transaction matching and electronic orders in the medical device network transaction for trading activities of both parties or parties of the transaction, and not Directly involved in the sale of medical equipment business.

 

In addition, the “Measures” also clearly stipulates that the medical device network information service shall be implemented in accordance with the “Measures for the Administration of Internet Drug Information Services”. Therefore, the third-party platform providers of the enterprises and medical device network transaction services that engage in the sales of medical device networks through self-built websites shall obtain Internet drug information service qualification certificates in accordance with the “Measures for the Administration of Internet Drug Information Services”.

Major obligations are imposed on third-party platform providers engaged in the sale of medical device networks and medical device network transaction services

The 3rd-party platform providers now must fulfill these obligations:

  • First, fulfill the filing obligations.
  • Second, the establishment of medical device quality management system. .
  • Third, examine the registration obligations.
  • Fourth is the qualification, place, technical conditions and management requirements.
  • Fifth, platform management obligations.
  • Sixth, record obligations.

 

The CFDA measures also define the following:

 

Scope of online operation of enterprises engaged in the sale of medical devices.

Medical device online sales of storage and distribution requirements

Prevention and Control Measures of Quality and Safety Risk in Online Sales of Medical Devices

Penalties on violations of these measures, down to responsible persons.

 

China has become the top nation with the largest online population leading the world e-commerce and online purchases. Medical devices are no exception to this rule. The internet should be an important marketing and sales channel in China for overseas device manufacturers. We’d like to help and make sure you are taking full advantage of the online channel in Channel while being compliant with all CFDA regulations.

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