Which medical device can be exempted from clinical trial in China? Download the exemption list now

China Food and Drug Administration (CFDA) have implemented the new medical device regulations with new submission requirements on clinical trial. The higher risk medical devices which designated as class II and III medical device by CFDA are required to submit the clinical study data which conducted in China, only when the medical device listed on the catalogue of medical device exempted from clinical trial in China.
CFDA will supplement this catalogue when some medical device's risk can be controlled in the using process. The first batch of medical devices exempted from clinical trial in China can be downloaded here.
The clinical trial of higher-risk medical devices should be approved by CFDA before conduct clinical study in China. CFDA will designate the specific medical devices and form the catalogue of class III medical devices required clinical trial approval. Any medical devices listed in the “catalogue of class III medical devices required for clinical trial approval”, companies must apply for its clinical trial approval prior to clinical study. The catalogue of class III medical devices required for clinical trial approval can be found here.
Medical device manufacturer need to understand that if clinical trials are required, it will impact the time to obtain the CFDA approval and further impact the time to market entry for your product in China, CIRS will give practical advice on clinical exemption in China and assist you marketing devices in China.