China begins implementation of new medical device audits

Beginning to put teeth to its promise of increased scrutiny of how medical devices are manufactured and sold, the Chinese government in April began requiring device firms to submit internal audits to regional regulators.

The new requirement issued by the National Medical Products Administration (NMPA) mandates that by June device companies audit their sales records, their management systems and the conditions of facilities where devices are stored and shipped. The audits will be reviewed by regulators, who may follow up with their own inspections.  The campaign by NMPA is designed to stop the use and sale of unregistered medical devices and to ensure the safety of devices offered for sale in China.