Medical devices - Quality management systems - Requirements for regulatory purposes (JIS version)
quality management system requirements for an organization that must show it can consistently provide devices and related services that meet customer and regulatory requirements. 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: GB/T 42061-2022, YY/T 0287-2017, Q10, ISO 13485, ISO 15189. 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.