QMS Overview — ISO 13485 & GOST R
The Russian QMS framework
Russia aligns its quality management system (QMS) requirements with ISO 13485:2016, adopted as GOST R ISO 13485. For device classes that require it, a valid ISO 13485 certificate from an accredited certification body is a mandatory component of the registration dossier.
Additionally, since September 2022 (with the transition period ending January 2024), Russia has introduced a system of manufacturing site QMS inspections conducted or recognised by Russian authorities, separate from third-party ISO 13485 certification.
When QMS certification is mandatory
| Device class | ISO 13485 Certificate required | QMS Inspection required |
|---|---|---|
| Class I | No | No |
| Class IIa (non-sterile) | No | No |
| Class IIa (sterile) | Yes | Yes — mandatory from 1 January 2024 |
| Class IIb | Yes | Yes — mandatory from 1 January 2024 |
| Class III | Yes | Yes — mandatory from 1 January 2024 |
From 1 January 2024, QMS inspections are mandatory before submission for new registrations and most registration amendments for Class IIa sterile, IIb, and III devices. This is a significant change affecting registration preparation timelines.
GOST R standards applicable to QMS
| Standard | Subject |
|---|---|
| GOST R ISO 13485 | QMS requirements for medical device manufacturers |
| GOST R ISO 14971 | Risk management |
| GOST R 51088-2013 | IVD testing requirements |
| GOST R 51352-2013 | Medical device investigations and trials |
Russian standards (GOST R) are maintained by Rosstandart. Many GOST R standards are verbatim adoptions of the corresponding ISO standard.
- Government Decree No. 135: QMS inspection rules
- Government Decree No. 136: QMS implementation requirements
- Rosstandart (GOST R standards): gost.ru