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.