NMPA Draft Catalog of Class III Medical Devices Requiring Clinical Trials

On June 24, the NMPA released the draft catalog of class III medical devices requiring clinical trial approval. In the draft catalog, the following device categories were proposed:

• Implantable cardiac rhythm management device
• Implantable ventricular assist system
• Implantable drug infusion device
• Artificial heart valve and intravascular stent
• Tissue engineering medical products containing living cells
• Absorbable implants for the fixation of long bone

The public consultation is currently running until July 31, 2020.

By Jacky Li. Contact Cisema if you would like to learn more about the above news.