Product Catalog of Class III Medical Devices Requiring Clinical Trial Approval

On June 24, 2020, CMDE start to collect comments on the Product Catalog of Class III Medical Devices Requiring Clinical Trial Approval (Draft 2020). NMPA drafted this new edition Catalog base on the current Product Catalog of Class III Medical Devices Requiring Clinical Trial Approval. This new Catalog may have an impact on the registration of six implant products including, Implantable ventricular assist system, Prosthetic Heart Valve and Endoprosthesis, Implantable drug infusion equipment, etc. If any of this may impact your business in China, your comments or opinions about the Catalog can be submitted by July 31, 2020, via email.

Link: http://www.nmpa.gov.cn/WS04/CL2102/378351.html