Declaration of Conformity certificates, formerly known as GOST-R certificates, are required for many industries in the Russian Federation, including medical devices. Declaration of Conformity certificates are issued by a Russian agency called Gosstandardt (GOST). This agency maintains a list of products subject to certification in Russia and also authorizes certain testing labs in the Russian Federation to perform the required testing on devices.
The Russian Declaration of Conformity certificate can best be described as a combination quality and product safety certificate. It's required because imported products must conform to Russian GOST standards which are very similar to international standards. Therefore, CE self-declaration cannot replace the Russian Certificate of Conformity.
Additionally, the Russian Ministry of Health (Roszdravnadzor) requires a separate Registration Certificate with almost identical testing of the product. Both certificates are required for foreign medical devices or they will be stopped upon entry by Russian Customs.
For an in-depth overview of the Russian regulatory approval process for medical devices, read our article that explains how the process works, how long it will take and how much it will cost.
The following documents will be required for the Declaration of Conformity application:
- Certificate of Registration in Russian Federation issued by Roszdravnadzor (legalized copy);
- Manufacturer brochure with product technical characteristics in Russian;
- Instructions for Use/Operations Manual in Russian;
- Test report protocols, issued by Russian accredited laboratories (valid for one year);
- Safety Certificates issued by international authorities;
- ISO 13485 or ISO 9001 certificate of the manufacturer;
- European Declaration of Conformity with the list of product codes and product names;
- Product labeling, and more.
Let us help you obtain a Declaration of Conformity certificate.
Emergo has the necessary contacts in Russia to assist with all aspects of medical device registration and Declaration of Conformity Certification. Our services include:
- Coordination with accredited testing labs within Russia to identify required product testing.
- Coordination of product sample shipment to authorized testing lab.
- Coordination of document translation into Russian.
- Assembly, preparation and submission of documents needed for Declaration of Conformity certification.
- Coordination and payment of application, testing and certification fees.
- Act as your official representative and a liaison between your company and Gosstandardt officials.
Please note that we only serve the medical device industry.
Please contact us for more information on assistance with Declaration of Conformity certification for medical devices in Russia.