China’s Food and Drug Administration (CFDA) has proposed exempting 25 categories of Class II medical devices from clinical trials. Altogether, there are 142 devices on the draft list, including:
- Single-use, sterile tissue clamps
- Blood and infusion warmers
- Medical gas alarm systems
- Portable oxygen concentrators
- Blood storage refrigerators
- Dental casting alloys
- Medical protective shoes
From now until June 30, 2013, the CFDA is seeking public comment on the draft list. Once the draft is approved, this will be the second batch of Class II medical devices exempt from clinical trials in China. The first batch was approved in November 2011 and included 21 categories of devices.
To be exempt from clinical trials, eligible medical device manufacturers must submit a special written application when they register their Class II medical devices.