NMPA announced Recall Notices for 16 imported medical devices in November.
For causes and model numbers of the recalls in November, please email info@ChinaMedDevice.com.
For Decree 29 Measures for the Administration of Medical Device Recall, please email us also. We charge nominal fees for the translation.
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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 agent 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.