The reorganization of the medical device registration system in China is going on: the CFDA has just issued two guideline drafts clarifying the need to execute local clinical trials involving devices under registration.

The lists of devices exempt from clinical trials have been expanded by identifying 259 class II and 93 class III Medical Devices.

Exempt class II devices include preoperative topical substances, surgical instruments such as surgical clamps and cutters, hemostatic bandages and bone surgery equipment.

Exempt class III devices include disposable syringes with and without needles, disposable needles, disposable insulin pen, ultrasound imaging equipment.

The CFDA will collect and examine all comments on these two guidelines before June 20, 2016.

For further information:
http://www.sfda.gov.cn/WS01/CL0779/153340.html
http://www.sfda.gov.cn/WS01/CL0779/153555.html