On April 29, the National Medical Products Administration (NMPA) issued the Work Plan of Regulating the Medical Device Network 2020 (hereinafter referred to as the Work Plan), which clearly stated that the competent departments should uphold the principles of “linkage of online and offline, combination of information and products”, strengthen the implementation of the management responsibility of third-party platforms for online trade services of medical devices and the main responsibility of enterprises involved in online sale of medical devices as well as the regulatory responsibility of local drug regulatory authorities, enhance monitoring of online trade in medical devices and crack down hard on violations of laws and regulations.
According to the requirements of the Work Plan, the third-party platforms for online trade services of medical devices should fully implement management responsibilities such as verification and registration of settled enterprises, quality and safety monitoring, information release of any potential risks in product quality and safety, prevention of illegal behaviors in online sales, termination of platform services for any serious violations of laws, suspension of platform services for serious illegal behaviors and compilation of relevant reports. All enterprises involved in online sale of medical devices should ensure the authenticity, accuracy, integrity and traceability of the information provided and guarantee the compliance of transaction behaviors.
It is specified in the Work Plan that local drug regulatory authorities at all levels should enhance monitoring on online sales of medical devices and the intensity of punishment, and carry out investigation on clues of violations found through online monitoring, public opinion monitoring, complaints and reports and deal with the violations in time. Focus should be placed on investigation and punishing the following violations of laws and regulations: a) The third-party platform fails to fulfill its legal obligations, or verify the settled enterprises, or monitor the sales behavior and information of medical devices on the platform, or terminate the online trade services and submit report for any violations found; b) Enterprises involved in online sales sell medical devices that have not been registered or filed and release false information about medical devices; c) Third-party platforms and enterprises involved in online sales do not cooperate with the supervision and inspection of drug regulatory authorities, and refuse, conceal or misrepresent relevant materials and data.
The Work Plan stressed that drug regulatory authorities at all levels should earnestly implement the “Four Strictest” requirements, intensify efforts in investigating and punishing violations of laws and regulations, and conduct thorough review of false information “online” without zero tolerance.
National Medical Products Administration