Medical device software - Software life cycle processes (JIS version)
development and maintenance of medical device software, whether it is a device itself or part of a finished device. Identical adoption of the international standard.
The text of this standard is sold by Japanese Industrial Standards Committee and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
No market listing is published yet.
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: IEC 62304, YY/T 0664-2020, GB/T 25000.51-2016, IMDRF GMLP guiding principles, IEC 82304-1. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.