Compared to domestic and foreign listed products, novel medical devices with new designs, materials or processes, or scope of application and pose a high risk to humans should be approved for clinical trials before the trials can be conducted in China.

Hence, NMPA seeks to strengthen the clinical-trial approval requirements for these selected variety of devices. Back in 25th August 2014, NMPA has published the Catalogue of Class III Medical Devices Requiring Clinical Trial Approval, listing eight categories. However, this list has now been revised to include only 6 types of devices.

The specific categories of medical devices to which the above principles apply are as follows:

No	Product category	Classification code	Product description
1	Implanted heart rhythm management device	12	Implanted pacemaker
			Implanted heart defibrillator
2	Implanted ventricle assist system	12
3	Implanted drug infusion device	12
4	Artificial heart valves and in-vascular stents	13	Artificial heart valve or valve repair device
			In-vascular stents
5	Tissue engineering medical products containing living cells	13/16/17
6	Absorbable implants for internal fixation of extremities with long bones	13

Reference:

Notice of NMPA on the Publication of the Class III Medical Device Catalog for clinical trial approval (revised 2020) (No. 61 of 2020)