On March 20, NMPA granted Innovation Approval to abdominal endovascular stent graft, manufactured by MicroPort, a Shanghai based company. It is the first Innovation Approval granted this year.
The approval notice states "a CUFF stent graft can be placed at the proximal end of the stent graft or a branch stent graft can be placed at the distal end of the stent graft stent as an extension", and, in terms of the delivery system, "the ultra-fine outer diameter enables the stent system to easily reach the lesion through sharply curved blood vessels"
For English version of Innovation Approvals Procedure, please email info@ChinaMedDevice.com.
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------