When exporting medical devices to the Russian Federation, customs authorities require, in addition to the GOST R certification, a proof of registration by the Federal Service of Health Care, an authority of the Russian Ministry for Health and Social Development. Such a registration is prerequisite for issuing GOST R certificates for medical devices.

The registration process comprises technical and clinical testing of the medical device. The Federal Service of Health Care decides on the scope of testing after reviewing the documents submitted.

At the client’s request, DIN GOST TÜV procures and supervises the registration of medical devices as well as the required tests by testing laboratories approved by the Russian Ministry for Health and Social Development.