23 NMPA Device Evaluation Reports in 2019: Guide Manufacturers for Market Entry

2020-02-29

NMPA CMDE (Center for Medical Device Evaluation) published Evaluation Reports for 23 innovative devices in 2019, aiding manufacturers on the vital points to obtain market approval, while committing itself for greater transparency and efficiency.

The NMPA Evaluation Reports, ranging from 20-page to 60-page, contain the following information:

Device description
Summary of pre-clinical research
Summary of clinical research
IFU analysis
Risk-benefit analysis

The 23 innovative devices, produced by domestic and overseas manufacturers, include but not limited to:

Cardio-Pulmonary

Thoracic aorta stent graft system
Left atrial appendage closure system
Pulmonary artery stent

Oncology

Linear accelerator system for radiotherapy
IMRT planning system software
Digital mammography system

Neuro

Neurosurgery navigation and positioning system

Orthopedic

Porous tantalum bone filling material

Immunology

Mycobacterium tuberculosis nucleic acid detection kit
Influenza A / B and respiratory virus nucleic acid detection Kit

For NMPA Evaluation Report for your specific device/IVD, please email us at info@inspirativemed.com. We can search it and translate the Report for you.