China issues new risk assessment report guidelines for medical devices

Medical device manufacturers seeking to market their products in China will be required to adhere to new guidelines in the risk assessments they submit to authorities, the National Medical Products Administration (NMPA) announced in August. The periodic risk assessment reports, which outline possible mishaps of using the devices, their likelihood and consequences, and the tolerances for such events, will be required annually for the first five years for Class I, II, and III devices. Renewal of medical device products will require a new report submission. 


The NMPA guidelines include instructions on how to format risk assessment reports, and mandate that they contain post-market and sales data and adverse event reports. The reports, which must contain basic product and risk information, including primary risk control measures, are required to be submitted in both Mandarin and English.