Home About Qualtech NEWS CHINA: NMPA Issued the Draft of Appendix of Medical Device Good Manufacturing Practice for SaMD - February, 2019
CHINA: NMPA Issued the Draft of Appendix of Medical Device Good Manufacturing Practice for SaMD - February, 2019

February 18, 2019

In order to strengthen the quality management of stand-alone software medical device products, the NMPA has drafted the “Appendix of Medical Device Good Manufacturing Practice for Stand-alone Software" (hereinafter referred to as "Appendix"), and solicits public opinion. This Appendix is expected to be officially implemented in 2020. All manufacturers of SaMD’s listed in China are expected to comply.

The “Appendix” itemizes the specific requirements of SaMD production quality management, and is used as reference for software component of the medical devices. NMPA places special requirements in various production stages and specific elements, such as personnel, equipment, design and development, procurement, production management, quality control, sales and after-sales service, non-conforming product control, adverse event monitoring analysis and improvement, among others. If the product possesses network capabilities or uses off-the-shelf software, the manufacturers also need to consider the relevant requirements to ensure its compliance.

NMPA stresses out that manufacturers shall consider the elements of software life cycle model in establishing the corresponding control procedures during the design and development stages which should ultimately result to an organized and efficient documentation. Manufacturers may derive strategies from the following three major aspects:

1. Identification of the requirement from the following activities: software requirements specification, software design, software coding, verification and validation, software updates, risk management, defect management, traceability analysis, configuration management, file management and recording protocol, off-the-shelf software use, network security assurance, software distribution, software deployment and software outage.

2. The requirement of Quality Assurance activity shall be proportionate to the software security level. The software security level shall be identified by the combined assessment of the software’s intended use, use environment and core functions of the software before risk control measures are taken, and the level can only be reduced by external risk control measures.

3. Software risk management activities shall be implemented in accordance with the risk management control procedures. The scope of risk covers product identification, analysis, evaluation, control and monitoring of software functions, interfaces, user interfaces, off-the-shelf software, network security and other related risks. Risk management and control process shall be carried out all throughout the software life cycle.

 

Reference:

Official press

 

 

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Home About Qualtech NEWS CHINA: NMPA Issued the Draft of Appendix of Medical Device Good Manufacturing Practice for SaMD - February, 2019