Product Catalog of Class III Medical Devices Requiring Clinical Trial Approval
On September 18 2020, CMDE released an amendment of the Product Catalog of Class III Medical Devices Requiring Clinical Trial Approval (Amendment 2020). This new edition Catalog is drafted based on the current Regulation on the Supervision and Administration of Medical Devices. 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. Bradynuoen can help you evaluate the possible influence of the Catalog on your product.
