Since the 2014 update to Chinese regulations, software is now clearly and unambiguously included in medical device regulation. The Chinese classification guidance included adjustments to software classification, raising all standalone medical device software to Class II or above. On 5th August, CFDA published its Software Registration Technical Review Guidance.
The implementation of this guidance has raised some confusions – and some specific practices continue even though they are not included in the guidance. For example, the following issues regularly crop up in product registration reviews:
- If full version and released version cannot be distinguished via Versioning Rules, all updates leading to changes in version name will be treated as Major Updates by CFDA, i.e. Variation Application will be required.
- Shelf life of software should be determined and justified by the manufacturer based on factors including running environment, hardware shelf life and also from commercial perspectives.
The following are issues which you need to consider when preparing software registration filings in China.
When compiling the Product Technical Requirements:
- Versioning Rules should include the description of how the Full Versions are named, as well as the Released Versions.
- Safety Requirements should demonstrate how the software complies with standards – including national and industrial compulsory/recommended standards.
In Clinical Evaluation:
- For software components of medical devices, the clinical evaluation should be done together with the medical device as an integral part. However, the processing function may be evaluated independently using the same methods as for standalone software.
- For standalone software (SaMD), it is possible to achieve clinical evaluation by establishing substantial equivalence with the same functionalities of predicate software (including other SaMD or software components of hardware devices) already marketed in China.
- If the SaMD has an Artificial Intelligence based algorithm, the comparison and evaluation in Clinical Evaluation Report must be done based on the Clinical Trial data of its in-China predicate.
Finally it’s important to remember and be clear in the Software Description File:
- One core algorithm can support/have multiple clinical functionalities and conversely…
- One core functionality can be supported by multiple algorithms.
Regulators everywhere are finding software challenging and increasing their attention in this area, China is no exception.
Click here to download an English Translation of the CFDA software Guidance
Click here for original from CFDA website (Mandarin)
Finally remember Design Controls matter in software development – and regulators will audit – including China.
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