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 the National Medical Products Administration (NMPA).
The Periodic Risk Assessment Report is needed to describe the likelihood, consequences and tolerances of the possible risks of using a device. They 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.
Registrants are required to prepare the report annually for all medical devices (including IVDs) listed in China. Reports for Class II and Class III devices should be submitted to NMPA via an online system. For class I devices, the report should be kept in the registrants’ possession and only be submitted when required.
An overseas registrant of imported medical devices may submit the report in English, although a Mandarin translation is required. Case reports of individual adverse events may be written in English only.
For detailed information on the guidance, click here.