Russian Sanitary-Epidemiological Conclusion (Hygiene Certificate)
All medical devices imported into Russia must have a GOST-R certificate. In addition, medical devices that come into contact with the skin must also be issued a Sanitary and Epidemiological Conclusion, commonly referred to as a Hygiene Certificate.
Common medical products that require a Hygiene certificate include products which may negatively affect patients or doctors must pass Sanitary and Epidemiological expertise. These can include: physiotherapeutic, diagnostic and therapeutic disposables and equipment (syringes, needles, face masks, resuscitators, anesthesia-respiratory disposables, disposables and equipment for transfusion therapy, and so on).
The Hygiene certificate proves that your product meets Russian regulations and standards and is issued by the Federal Service for Supervision in the Area of Consumer Rights and Welfare Protection (Rospotrebnadzor). Toxicology test must be performed before submission to Roszdravnadzor. Most hygiene certificates are valid for five years.
We can help you obtain a Hygienic Certificate for your product.
Emergo Group maintains a presence in Moscow and can fully assist you in preparation of the documentation needed to obtain the GOST-R and Hygiene certificates:
• Preparation of the application to Rospotrebnadzor.
• Assembly and submission of Russian normative documents necessary for the application.
• Coordination of Sanitary and Epidemiological testing with accredited labs in Russia.
• Translation of documentation necessary for the application.
