China – China Starts Clampdown on Unregistered Devices, Threatens Severe Punishments

China has begun an eight-month drive to stop the use and sale of unregistered medical devices. The first stage of the crackdown will require organizations to audit themselves and report their findings to regional regulatory offices.

The first stage of the National Medical Products Administration (NMPA) campaign, dubbed Clearnet, will run from late April to June. Over that period, NMPA expects organizations involved in the sale of medical devices to inspect their operations. The self-inspections should look at information including sales records, the establishment and implementation of management systems and the conditions in which devices are stored and shipped.

NMPA is asking the organizations to share the results of the self-inspections with its regional offices. These regulatory offices will oversee the second stage of Clearnet from July to October. Over those months, the regional offices will review and act on the the self-inspection reports by performing their own inspections and taking other actions…