China Med Device Company Brochure
China Med Device, LLC (https://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.
Registration, Renewal & Amendment in China
For Medical Device/IVD/CDx/Combination ProductRegistration StrategyPre consultation with NMPA reviewerRegistration, modification, renewal submission & communicationPTR writing and onsite type testing supportSoftware and cybersecurity documents writign compliant ...
E: [email protected]
T: (978) 390-4453
800 Turnpike St., Suite 300, North Andover, Massachusetts, 01845, United States