Analysis of recommendation No. 17 of Federal Service for Surveillance in Healthcare

The transfer of Russian economics to Eurasian Economic Union leads on the changes in the routines of State registration for medical devices.

One of the recommendation of Federal Service for Surveillance in Healthcare, concerned with the Russian transfer to Eurasian Economic Union is (Recommendation No. 17). It contains the list of standards, the application of which, on a voluntary basis, fully or partially ensures the conformity of medical devices to the General Requirements for the safety and performance of medical devices, requirements for their marking and operational documentation for them.

The analysis of this recommendation shows that the routines of State registration for medical devices become more harmonized with the international routines, and more and more standards become harmonized with the international ones.

For example, the range of toxicology standards GOST ISO 10993 is identic with the international range of standards ISO 10993;

The ranges of electrotechnical standards GOST IEC 60601 and GOST IEC 61010 are identical with the ranges EC 60601 and IEC 61010 respectively;

The same situation we can observe also with standards for sterile and implantable medical devices.

In addition to this we can observe, that the recommendation No. 17 doesn’t contain unique Russian standards GOST R 50444, GOST 20790 and GOST 15150.

So, we can conclude, that now it is easier to make sure, that imported medical devices comply with Russian requirements for the safety and performance.

| Applied standards - review

For different product types:

• IVD - find here 
• Electrical medical devices
• Sterile medical products
• Implantable medical devices

For biocompatibility testing - find here.