2014 Changes to China’s Adverse Events Reporting for Medical Devices

As China’s Food and Drug Administration (CFDA) undergoes reorganization, it is placing more emphasis on post-market compliance for medical devices. This includes changes to processes such as Adverse Events (AE) reporting and the re-registration of medical devices. Both of these processes will experience major changes in 2014 and 2015.

In 2014, the CFDA will set up a new reporting platform to standardize and improve monitoring procedures for medical device AEs. The platform will undergo one year of testing and review before it goes live in 2015. During the testing period, all Class III medical device manufacturers and distributors, in 2014, must submit reports to the new system. Manufacturers and distributors of Class II medical devices will be required to use the new system starting in 2015.

Also in 2015, all hospitals, distributors, and medical device manufacturers will be required to submit annual AE assessment reports. Even if a medical device has experienced no AEs in a given year, a report must still be submitted. Medical device manufacturers without an office in China can have their distributor submit this information on their behalf.

Finally, major changes are coming to China’s medical device re-registration process. Currently, medical devices registered in China must be re-registered once every four years. Sometime in 2014, re-registration requirements are expected to change to once every five years. In addition, starting in 2014, manufacturers of Class III medical devices must prove that they have AE reporting systems in place whenever they register or re-register their Class III devices.

China’s AE reporting system has been in place since 2010, but it is often ignored by medical device manufacturers, distributors, and medical institutions. In 2012, for example, there were only 947 AE reports for 14,000 registered device manufacturers and 70,000 registered medical devices. This compares to an annual average of nearly 20,000 medical device AEs reported to the US Food and Drug Administration.