The regulatory landscape is evolving: medical device regulators are expecting more mature risk management systems and processes. Further, recent standards revisions and emerging regulations -...
In Brief: New Medical Device Software Guidance from Chinese FDA
The Chinese Food and Drug Administration (CFDA) has published new guidelines covering technical review components of medical device software registration.
The guidelines (link in Chinese) cover development methods for standalone and off-the-shelf software that function either as standalone medical devices or as components of or accessories to devices.
Requirements for software updates as well as upgrades are included in the CFDA guidelines. Software description and technical information documentation requirements are explained, as well as product registration information. The guidance also includes a template for software technical data submissions.
Emergo consultants will provide further details and analysis on how these new guidelines will affect medical device software registrations in China as we learn them.
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