February 09, 2018

The CFDA has approved "The Administration Regulation for Online Medical Device Sales" (hereinafter referred to as the “Regulation”) proposed last November 7 2017, and will be fully implemented on March 1 2018. A total of 50 Clauses, including legislative purposes and scope, are outlined in the Regulation. In addition, the regulation clearly indicates the obligations, supervision and legal responsibilities of the medical device enterprise and third-party trading platform provider engaging in online medical device sales.

The scope of the regulation is as follows:

1.      The definition of “the enterprise engaging in online medical device sales” and “the third-party trading platform providers for online medical device sales”.

2.      The responsibilities and obligations of “the medical device enterprise” and “third-party trading platform provider engaging in online medical device sales”.

3.      Scope and limitations of online business for medical equipment enterprise.

4.      List of all the storage and distribution requirements for online selling of medical devices

5.      List of the responsibilities of CFDA branch in the online sales.

6.      List of the preventive measures for ensuring quality and safety of medical devices sold online.

7.      Legal responsibilities, sanctions and penalties for illegal network sales (and other related violations) carried out by third-party trading platform providers and the medical device enterprise.

Reference

1.  The Official Press from CFDA

2. “The Administration Regulation for Online Medical Device Sales”

3. The interpretation of “The Administration Regulation for Online Medical Device Sales”