The European Commission has published harmonized standards for medical devices
The European Commission has published harmonized standards for medical devices

The European Commission has recognized 9 harmonized standards from the International Organization for Standardization (ISO) and the International Electrical Commission (IEC) related to medical devices. These ISO and IEC documents are used unchanged like European standards EN ISO or EN IEC.

Draft law on conformity of medical devices with the requirements of EAEU was adopted on first reading in Russia
Draft law on conformity of medical devices with the requirements of EAEU was adopted on first reading in Russia

According to this draft law, compliance with the requirements of the quality management systems (ISO 13485) on the production sites of medical products can be taken into account and the same requirements for foreign and domestic manufacturers can be established.

GOST medical devices Russia
Russia introduces new GOST standards for in-vitro medical diagnostics

The Federal Agency for Technical Regulation and Metrology (Rosstandart) passed five new national GOST standards for devices for in-vitro medical diagnostics

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