NMPA (CFDA) GMP for Software: Eight Requirements You Must Follow

NMPA (CFDA) Roundup 201907
August 6, 2019
Beijing IVD Inspection Starts Today! 13 Requirements You Must Follow
August 16, 2019

NMPA (CFDA) GMP for Software: Eight Requirements You Must Follow

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:

  1. Personnel
  2. Equipment
  3. Design development
  4. Procurement
  5. Manufacturing management
  6. Quality management
  7. Sale and after-sale
  8. Adverse event monitoring and analyzing

Synchronization of International Standards

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 for your standalone software. info@ChinaMedDevice.com

Standalone Software Registration

The announcement of GMP Annex on Standalone Software enhanced China GMP system, after publication of the following eight documents:

  1. Good Manufacturing Practice for Medical Devices
  2. Good Manufacturing Practice Annex on Class III Medical Devices
  3. Good Manufacturing Practice Annex on Sterile Medical Devices
  4. Good Manufacturing Practice Annex on Implantable Medical Devices
  5. Good Manufacturing Practice Annex on In Vitro Diagnostic Reagents
  6. Good Manufacturing Practice Guidelines for Onsite Inspection
  7. Good Manufacturing Practice Guidelines for Onsite Inspection of Sterile Medical Devices
  8. Good Manufacturing Practice Guidelines for Onsite Inspection of Implantable Medical Devices

For English version of any documents mentioned above, please email info@ChinaMedDevice.com.

To keep up to date on NMP (CFDA) changes, please opt in our monthly newsletter https://ChinaMedDevice.com/cmd-blogs/

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.