Key GOST R Standards
What are GOST R standards?β
GOST R (ΠΠΎΡΡΠ΄Π°ΡΡΡΠ²Π΅Π½Π½ΡΠΉ ΡΡΠ°Π½Π΄Π°ΡΡ β State Standard) are Russian national standards published by Rosstandart (the Federal Agency on Technical Regulating and Metrology). Many GOST R standards in the medical device space are verbatim or technically equivalent adoptions of the corresponding ISO or IEC standard, making compliance with international standards a strong basis for GOST R compliance.
Key GOST R standards for medical devicesβ
| GOST R Standard | ISO/IEC equivalent | Subject |
|---|---|---|
| GOST R ISO 13485 | ISO 13485:2016 | Quality management systems for medical devices |
| GOST R ISO 14971 | ISO 14971:2019 | Application of risk management to medical devices |
| GOST R 51088-2013 | β | In vitro diagnostic medical devices β registration requirements |
| GOST R 51352-2013 | β | Medical devices β investigations and trials |
| GOST R IEC 60601-1 | IEC 60601-1 | Electrical safety β general requirements for medical electrical equipment |
| GOST R ISO 10993 series | ISO 10993 series | Biological evaluation of medical devices |
Standards required in registration dossiersβ
The registration dossier should reference and demonstrate compliance with applicable GOST R standards. The FGBU expert institution will assess whether the testing and documentation comply with these standards. Where a manufacturer has complied with the international ISO/IEC equivalent rather than the GOST R adoption, this is generally accepted but should be clearly documented.
Mandatory GOST certification (Decree No. 2425)β
A subset of medical devices is subject to mandatory GOST certification or GOST declaration β separate from the Roszdravnadzor registration process. Government Decree No. 2425 (September 2022) updated the list of products subject to these requirements. Check the list to determine whether your device category is included.
Rosstandart (GOST R standards): gost.ru
Government Decree No. 2425: government.ru