US and China Medical Devices Task Force

On September 11, 2009, China’s State Food and Drug Administration (SFDA) hosted a Medical Devices Task Force meeting in China. The agenda covered various medical device topics and regulations.

For clinical trials, the US encouraged China to adopt a risk based approach to clinical trials. Also, the US asked China to accept clinical data from past overseas trials versus requiring new clinical trials in China. Other requests included the US asking China to require trials based on individual product risk instead of by class. The SFDA is making efforts to harmonize its clinical trial regulations with global practices, while also accounting for their unique domestic environment. The draft regulation will be posted on the SFDA website between October and December 2009.

For product registration, there were discussions on how to address China’s requirement for marketing approval from the export country as a pre-requisite. There are many situations where a company will design and manufacture a product specifically for the China market, so getting approval in another market does not make sense. A possible solution is to accept approval from any EU or GHTF (Global Harmonization Task Force) /AHWP (Asian Harmonization Work Party) country.

The SFDA is contemplating new regulations where they would conduct pre-approval QMS (Quality Management Systems) inspections on a device-by-device basis. The US noted that this can be resource intense and an inefficient process, suggesting that an effective QMS should be qualified based on the manufacturing facility. Therefore, all the registration applications of that manufacturer’s facility would be qualified.

Future plans also mentioned in this task force include updating adverse event reporting, implementing regulations for recalls, and addressing IVD (In-Vitro Diagnostic) classification and regulation.