As innovative devices and first-of-kind products enter the China market, the NMPA seeks to strengthen the clinical trial approval requirements for certain devices.
Not all of them require NMPA clinical approval to begin clinical trial but for some there is an extra step. NMPA published the final version of Catalog of Class III Medical Devices Requiring Clinical Trial Approval on September 18, 2020.
- Implantable cardiac pacemaker, implantable cardiac defibrillator
- Implantable blood pump
- Implantable drug infusion pump
- Artificial heart valve and intravascular stent with new mechanism or new materials
- Tissue engineering medical products containing living cells
- Long bone internal fixation products made with absorbable polymer material or absorbable metal material
NMPA initially implemented the clinical approval catalog in August 2014. Several changes have been made after the version, in which some device catalogs such as 3D orthopedic devices were removed. The latest one was issued in December 2019 where the following devices were included. Now they are removed from the 2020 version:
- Non-active implantable medical devices in orthopedic and dental applications which are not yet available on China or overseas market
- Nano orthopedic implant which are not yet available on China or overseas market
- Combination device / bioactive factor / cell orthopedic implant which are not yet available on China or overseas market
- Newly designed orthopedic or dental implants which are not yet available on China or overseas market
For our comments on 2019 catalog, please click HERE.
Overseas Clinical Data
If your device falls into the Catalog you need to go through the extra step to obtain clinical trial approval from NMPA. On the positive side for manufacturers, overseas clinical data is applicable for the six categories of devices, according to the Guideline for Acceptance of Overseas Clinical Trial Data of Medical Devices issued on January 11, 2018.
Overseas clinical data acceptance has become one of the major pathways for clinical evaluation, along with clinical trial, clinical evaluation report (CER) and real-world data (RWD). The latest example was Edwards Lifesciences who went through the pathway of Overseas Clinical Data Acceptance for its transcatheter aortic valve system and obtained innovation approval on June 8, 2020.