Published on

July 17, 2020

Last updated on

March 11, 2026

15 New NMPA Technical Review Guidelines for Medical Device Registrations

15 New NMPA Technical Review Guidelines for Medical Device Registrations

On June 5, the NMPA issued the technical review guidelines (No. 36 – 2020) for the registration of the following medical devices:

  • Tendons and Ligament Fixation Device
  • 3D Printed Acetabular Cup
  • 3D Printed Artificial Vertebral Body
  • Facial Implants for Plastic Surgery
  • Total Knee Prosthesis System

On June 17, the NMPA issued the technical review guidelines (No. 39 – 2020) for the registration of the following medical devices:

  • Heat and Moisture Exchanger
  • Low Frequency Electrotherapy Instrument
  • Electrical Pneumatic Tourniquet Device
  • Spirometry Device
  • Medical CO2 Incubator
  • Shockwave Therapy Device
  • Hot Therapy Pack
  • Audiometer

On June 17, the NMPA issued the technical review guidelines (No. 42 – 2020) for the registration of the following medical devices:

  • Synchronized Cardioversion Device
  • Transcutaneous Pacemaker

By Jacky Li. Contact Cisema if you would like to learn more.

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