Medical device Declaration of Conformity certificates in the Russian Federation

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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 and internationally to perform the required testing on devices. Declaration of Conformity certificates are required in Russia and Belarus, and very effective toward obtaining certification in Kazakhstan, Georgia, Azerbaijan, Moldavia and Baltic Countries (but not Ukraine).

The Russian Declaration of Conformity certificate can best be described as a combination quality and product safety certificate, similar to a CE Marking certificate. It's required because imported products must conform to Russian standards which are (unfortunately) not yet harmonized with European or International standards. Therefore CE self-declaration cannot replace the Russian Certificate of Conformity. However, if you already have an ISO certified quality system, it will be easier for us to help you coordinate Declaration of Conformity certification for your company / medical device.

Declaration of Conformity certification is based on the submission of documents contained in a Technical Report and on product testing results. Adding to the confusion is the fact that the Russian Ministry of Health (Roszdravnadzor) actually 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)
• Contract for the supply of medical devices (if available)
• Manufacturer brochure with product technical characteristics in Russian
• Instructions for Use/Operations Manual in Russian
• Protocols, test reports, given out by Russian accredited laboratories (valid for one year)
• Safety Certificates issued by International Authorities
• ISO 13485 or ISO 9001 certificate of the manufacturer
• Declaration of Conformity with the list of product codes and product names
• Product labeling, photo of the product or samples

Our team in Moscow is highly experienced with medical device registration in Russia and CIS countries.

Let us help you obtain a Declaration of Conformity certificate.

Emergo Group maintains a local presence in Moscow and we can fully assist you in coordinating your Declaration of Conformity and registration certification. Our services include:

• Assistance with submission of your product for testing in Russia.
• Assembly, preparation and submission of Technical Report needed for Declaration of Conformity certification.
• Coordination of translation of documents into Russian.
• Coordination and payment of application, testing and registration 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 a free proposal or more information on assistance with Declaration of Conformity certification for medical devices in Russia.