Medical devices - Quality management systems - Requirements for regulatory purposes
The text of this standard is sold by ISO 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
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| United States | Referenced | ISO 13485:2016 as incorporated by reference in 21 CFR 820 | - | Mandatory for manufacturers through the quality management system regulation, which incorporates the standard by reference. |
| European Union | Harmonized | EN ISO 13485:2016 with corrigendum AC:2018 and amendment A11:2021 (ISO 13485:2016) | - | Recognition number MDR entry 10; IVDR entry 7. Effective January 5, 2022. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
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, JIS Q 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.
| United Kingdom | Recognized | EN ISO 13485:2016 with corrigendum AC:2018 and amendment A11:2021 | - | Recognition number List row 126. Voluntary: a device that conforms to a designated standard is treated as complying with the related essential requirement unless there are reasonable grounds to suspect that it does not. |
| Japan | National equivalent | - | MHLW Ministerial Ordinance 169 of 2004 (QMS Ordinance)Ordinance on standards for manufacturing control and quality control of medical devices and in vitro diagnostic reagents | Quality system compliance is judged against the national QMS ordinance, which is based on ISO 13485. A compliance certificate is issued after inspection.. JIS Q 13485:2018 is the identical Japanese version of ISO 13485:2016 but the legal standard is the ministerial ordinance. |
| China | National equivalent | - | GB/T 42061-2022Medical devices - Quality management systems - Requirements for regulatory purposes | Effective November 1, 2023. National standard on the same subject with the same title. The earlier industry standard YY/T 0287-2017 was abolished on the day this one came into force. |
| Canada | Referenced | - | CAN/CSA-ISO 13485Medical devices - Quality management systems - Requirements for regulatory purposes | Named in the licence application rules for Class II, III and IV: a quality management system certificate to this national standard is part of the application. |
| Australia | Recognized | ISO 13485:2016 | - | Named for the quality management system procedures in Parts 1, 4 and 5 of Schedule 3.. Compliance with the standard is treated as applying the matching parts of the conformity assessment procedures. It is an optional route. |