NMPA is Revising Clinical Trial Approval Catalog

In One Day, Two AI Diagnostic Software Go into NMPA Fast-Track Channel
July 8, 2020
NMPA News Roundup June 2020
July 14, 2020

NMPA is Revising Clinical Trial Approval Catalog

As innovative devices and first-of-kind products enter China market, 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 draft version of Catalog of Class III Medical Devices Requiring Clinical Trial Approval on June 25, 2020. Feedbacks need to be submitted by July 31, 2020.

Current Proposed Category

  1. Implantable cardiac pacemaker, implantable cardiac defibrillator
  2. Implantable blood pump
  3. Implantable drug infusion pump
  4. Artificial heart valve and intravascular stent with new mechanism or new materials
  5. Tissue engineering medical products containing living cells
  6. Long bone internal fixation products made with absorbable polymer material or absorbable metal material

Multiple Revisions

NMPA initially implemented the clinical approval catalog in August 2014 when, for example, 3D orthopedic devices were on the list. Several changes have been made after the version. The latest one was issued in December 2019 where the following devices were included. Now they are removed from the 2020 draft version:

  1. Non-active implantable medical devices in orthopedic and dental applications which are not yet available on China or overseas market
  2. Nano orthopedic implant which are not yet available on China or overseas market
  3. Combination device / bioactive factor / cell orthopedic implant which are not yet available on China or overseas market
  4. 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

On another 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).