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:
- Design development
- Manufacturing management
- Quality management
- Sale and after-sale
- Adverse event monitoring and analyzing
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.
China Med Device, LLC can help you establish GMP system, submit NMPA applicable GMP documents and conduct mock inspection. info@ChinaMedDevice.com
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:
- Good Manufacturing Practice for Medical Devices
- Good Manufacturing Practice Annex on Class III Medical Devices
- Good Manufacturing Practice Annex on Sterile Medical Devices
- Good Manufacturing Practice Annex on Implantable Medical Devices
- Good Manufacturing Practice Annex on In Vitro Diagnostic Reagents
- Good Manufacturing Practice Guidelines for Onsite Inspection
- Good Manufacturing Practice Guidelines for Onsite Inspection of Sterile Medical Devices
- Good Manufacturing Practice Guidelines for Onsite Inspection of Implantable Medical Devices
For English version of any documents mentioned above, please email info@ChinaMedDevice.com.
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About ChinaMed Device, LLC
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.