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.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
The post In Brief: New Medical Device Software Guidance from Chinese FDA appeared first on MassDevice.
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