On April 15, NMPA issued an action plan on the "clearance" action for medical devices and deployed and carried out the "clearance" action around China.
The issue-oriented "clearance" action focuses on illegal acts including sale of medical devices without licenses via internet and sale of unregistered medical devices. It is to strictly investigate and punish enterprises that violate laws and regulations, clear up a number of illegal websites, expose a number of typical cases, so as to purify the marketing environment for medical devices. Third-party platforms for medical device online trading service and enterprises for medical device online sales are supervised and urged to carry out comprehensive self-inspection and rectification according to such rules and regulations as Regulations on the Supervision and Administration of Medical Devices and Measures for the Supervision and Administration of Online Sale of Medical Devices and further strengthen the entity responsibility.
The "clearance" action had three stages, for enterprise self-inspection from late April to June, for inspection by regulatory authorities from July to October and for summary and evaluation from October to December.
According to the action plan, third-party platforms should establish and implement the management system and carry out comprehensive self-inspection and rectification based on office conditions, personnel and organization arrangement, platform filing and information display and submit reports to the provincial drug regulatory authorities. Enterprises for medical device online sales should carry out comprehensive self-inspection and rectification based on qualification, information release, sales records, storage and transportation conditions and other aspects of online medical devices and products and submit reports to municipal departments responsible for the supervision of medical devices.
The action plan also points out that the provincial drug regulatory authorities mainly inspect whether third-party platforms provide medical device trading services for settled enterprises and directly sell medical devices online without filing, fail to provide corresponding technical conditions, quality management institutions or personnel as required or engage in other acts, and whether third-party platforms perform obligations to verify and register settled enterprises and stop and report online sales of medical devices by settled enterprises violating laws and regulations as required. Municipal and county-level departments responsible for supervision of medical devices should mainly inspect whether enterprises for medical device online sales fail to obtain "offline" medical device production license, business certificate or filing certificate of the second type of medical devices, or fail to obtain "online" registration certificate and filing certificate and engage in other acts related to illegal medical device products, display of false information of enterprises and products. They should also carry out "offline" investigation, expose "illegal websites" and remove "illegal points of sales" according to "online" illegal product information, so as to severely crack down on illegal activities via internet.
According to the action plan, departments responsible for the supervision of medical products at all levels should increase legal training for third-party platforms and enterprises for medical device online sales, improve the corporate awareness of abiding the law and trustworthiness, and strictly fulfill legal obligations and really implement enterprise responsibility. They should also intensify monitoring, supervision and inspection to find third-party platforms and enterprises for medical device online sales that fail to carry out self-inspection and rectification as required and are absent from legal training, and interview with the legal representatives or main leaders of those platforms and enterprises, and strictly punish illegal acts found in accordance with laws. Besides, they should list third-party platforms and enterprises for medical device online sales and legal representatives or main leaders with serious violations of laws and regulations as dishonest enterprises and dishonest personnel, make them known to the public and implement joint punishment.
NMPA will supervise and inspect the implementation of the "clearance" action in various regions.
The issue-oriented "clearance" action focuses on illegal acts including sale of medical devices without licenses via internet and sale of unregistered medical devices. It is to strictly investigate and punish enterprises that violate laws and regulations, clear up a number of illegal websites, expose a number of typical cases, so as to purify the marketing environment for medical devices. Third-party platforms for medical device online trading service and enterprises for medical device online sales are supervised and urged to carry out comprehensive self-inspection and rectification according to such rules and regulations as Regulations on the Supervision and Administration of Medical Devices and Measures for the Supervision and Administration of Online Sale of Medical Devices and further strengthen the entity responsibility.
The "clearance" action had three stages, for enterprise self-inspection from late April to June, for inspection by regulatory authorities from July to October and for summary and evaluation from October to December.
According to the action plan, third-party platforms should establish and implement the management system and carry out comprehensive self-inspection and rectification based on office conditions, personnel and organization arrangement, platform filing and information display and submit reports to the provincial drug regulatory authorities. Enterprises for medical device online sales should carry out comprehensive self-inspection and rectification based on qualification, information release, sales records, storage and transportation conditions and other aspects of online medical devices and products and submit reports to municipal departments responsible for the supervision of medical devices.
The action plan also points out that the provincial drug regulatory authorities mainly inspect whether third-party platforms provide medical device trading services for settled enterprises and directly sell medical devices online without filing, fail to provide corresponding technical conditions, quality management institutions or personnel as required or engage in other acts, and whether third-party platforms perform obligations to verify and register settled enterprises and stop and report online sales of medical devices by settled enterprises violating laws and regulations as required. Municipal and county-level departments responsible for supervision of medical devices should mainly inspect whether enterprises for medical device online sales fail to obtain "offline" medical device production license, business certificate or filing certificate of the second type of medical devices, or fail to obtain "online" registration certificate and filing certificate and engage in other acts related to illegal medical device products, display of false information of enterprises and products. They should also carry out "offline" investigation, expose "illegal websites" and remove "illegal points of sales" according to "online" illegal product information, so as to severely crack down on illegal activities via internet.
According to the action plan, departments responsible for the supervision of medical products at all levels should increase legal training for third-party platforms and enterprises for medical device online sales, improve the corporate awareness of abiding the law and trustworthiness, and strictly fulfill legal obligations and really implement enterprise responsibility. They should also intensify monitoring, supervision and inspection to find third-party platforms and enterprises for medical device online sales that fail to carry out self-inspection and rectification as required and are absent from legal training, and interview with the legal representatives or main leaders of those platforms and enterprises, and strictly punish illegal acts found in accordance with laws. Besides, they should list third-party platforms and enterprises for medical device online sales and legal representatives or main leaders with serious violations of laws and regulations as dishonest enterprises and dishonest personnel, make them known to the public and implement joint punishment.
NMPA will supervise and inspect the implementation of the "clearance" action in various regions.