The CFDA has announced the release of its “Principle of technical review of medical device software” (2015 Order No. 50). This Principle applies to both stand-alone software and software components that are either developed by medical device manufacturers or their design and development partners, including any Off-The Shelf (OTS) software as part of the stand-alone software or component; or are fully adopted OTS software used in the medical device.
The updated CFDA announcement clearly points out that software safety and effectiveness will be achieved based on the application of risk management, quality assurance, and software lifecycle processes utilized during the software development.
The essential points of consideration are:
Software safety classification is categorized into three different classes – Class A, B and C, based on the national standard, YY/T 0664 – Medical device software- Software life cycle process (identical to IEC 62304).
Software updates are a new addition to this announcement. The adoption of national standard, GB/T 20157 – Information Technology – Software maintenance (identical to ISO/IEC 14764), forms the core idea of this rule. Two focal points are stressed:
Major software update – Enhanced software update that impacts medical device safety and effectiveness
Minor software update –Enhanced or corrective software update which does not impact medical device safety and effectiveness
The software version should include revision, publishing date, and should be clearly communicated to the CFDA. Therefore, the naming convention should clearly identify both: (1) the full software version which includes a means to indicate both major and minor software updates, and (2) the published software version –major software updates only.
Off the Shelf (OTS) software refers to software either (1) commercially acquired from market, (2) previously developed by the manufacturer but lacking in development documentations, or (3) outsourced to a supplier to develop.
If OTS software is partially used, the manufacturer should still provide a briefer version of the software descriptive documents.
Registration Unit: For stand-alone software, the consideration principle of grouping into a registration unit includes intended use, device category, and clinical functions. For software components, software registration should be with the associated medical device.
Testing Unit: The Testing Unit describes the representative device when registered. For stand-alone software, every non-compatible operation environment and every independent published software version should be regarded as a sole testing unit. For software components, the testing unit should be with the accompanied medical device.
The Registration requirements cover stand-alone software and software components including product name and composition, software descriptive documentations, software version, product technical specifications, clinical evaluations, OTS software and user’s manual. This announcement provides detailed documentation requirements and templates for application.
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