NMPA (CFDA) published Good Manufacturing Practice Annex on Standalone Software on July 12. After satisfying Good Manufacturing Practice on Medical Devices, software manufacturers have to meet the eight special requirements listed in the Standalone Software Annex:
The Annex is based on Software as a Medical Device (SaMD): Application of Quality Management System, published by International Medical Device Regulators Forum (IMDRF), and international standard IEC 62304.
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NMPA also states that three already issued guidelines, Software Technical Review Guideline, Cyber Security Technical Review Guideline, and Mobile Device Technical Review Guideline can be used as references for standalone software registration.
The announcement of GMP Annex on Standalone Software enhanced China GMP system, after publication of the following eight documents:
For English version of any documents mentioned above, please email info@ChinaMedDevice.com.
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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.