Medical devices - Quality management systems - Requirements for regulatory purposes
National standard on quality management system requirements for organizations in the medical device life cycle, for regulatory purposes. It has the same title as the international standard ISO 13485:2016.
Current. It replaced YY/T 0287-2017 on the same subject, which was abolished on 2023-11-01.
The text of this standard is sold by China national standard 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.
Related standards: YY/T 0287-2017, Q10, JIS Q 13485, 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.