CFDA granted 4 medical devices Innovation Approval, and 1 device Priority Review on May 22. Johnson & Johnson and Medtronic are on the list.
- Medtronic: percutaneous implanted aortic valve system
- Biosense Webster (subsidiary of J & J): 3D multichannel radiofrequency balloon catheter
- Quanjing Hengsheng: intravascular imaging system
- Aipute: pressure-induced ablation catheter
- XingyueBio: silk fibroin protein wound dressing
Medical device with Innovation Approval meets the three eligibility criteria of invention patent holder, significant clinical advantage, and verified prototype. Priority Review designated device deals with rare diseases, cancers, geriatric and pediatric diseases with unmet medical needs.
Applications which are granted an Innovation Approval or Priority Review designation will be allocated ‘front-of-queue’ priority throughout the relevant assessment process. Such designations do not alter the scientific/medical standard for approval or the quality of evidence necessary.
For CFDA guidelines about Innovation Approval or Priority Review, please email info@ChinaMedDevice.com
About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA, post market compliance. We are experienced in handling innovation approval and priority review. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ companies’ success.