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:
- Thoracic aorta stent graft system
- Left atrial appendage closure system
- Pulmonary artery stent
- Linear accelerator system for radiotherapy
- IMRT planning system software
- Digital mammography system
- Neurosurgery navigation and positioning system
- Porous tantalum bone filling material
- 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@ChinaMedDevice.com. We can search it and translate the Report for you.
For review of Innovation Approvals in 2019, please click HERE.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal representative with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.