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Companies exporting medical equipment to the Russian Federation are required to have GOST R certificate and a proof of registration by the Federal Agency of Health Care, an autority of the Ministry of Health and Social Development of the Russian Federation. This registration is precondition for issuing GOST R certificates for medical equipment.

The registration process comprises technical and clinical testing of the medical equipment. The Federal Agency of Health Care decides on the scope of testing.

SOEX procures and supervises the registration of medical equipment as well as required tests by testing laboratories approved by the Russian Ministry of Health and Social Development.

 

Sample:
Auszug aus dem Register der Medizinprodukte / Extract from the medical products registry / Свидетельство о регистрации медицинского продукта

Auszug aus dem Register der Medizinprodukte / Extract from the medical products registry / Свидетельство о регистрации медицинского продукта