Published on
Last updated on
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.
Related News
Malaysia Introduces New e-IFU & Digital Labelling Guidance for Medical Devices
Malaysia’s MDA publishes the 7th edition of guidance on medical device labelling, with new e-labelling, e-IFU, and accessibility requirements
Vietnam Authorities Step Up Cosmetic Recalls as Enforcement Tightens
Vietnam’s Drug Administration (DAV) is stepping up cosmetic product recalls as post-market surveillance tightens.
BPOM Clarifies Indonesia–US Trade Agreement Impact on Pharmaceutical Regulation
BPOM confirms pharmaceutical authorization, GMP oversight, and regulatory authority remain unchanged under the Indonesia–US trade agreement.