Russia “Declarant” representation for medical device Declaration of Product Conformity

Most medical device market regulators require foreign manufacturers to appoint in-country representatives to serve as points of contact for device registrations, inspections and vigilance efforts. If you have no local presence in Russia, Emergo Group can serve as your Declarant.

In Russia, a Declarant is required to assume responsibility for a manufacturer’s device and liaise with Russian regulatory authorities. Your Declarant can manage your Declaration of Conformity certification, as well as undertake necessary tasks such as incident reporting, notifications of product changes to the Roszdravradzor and Gosstandart authorities.

Choosing Emergo Group as your Russia Declarant

Through our office in Moscow, Emergo Group has the expertise and local know-how to support your in-country representation requirements in Russia. As your Declarant in the Russian medical device market, Emergo Group can provide the following services:

Authorize the use of the Emergo Group name and mailing address on your labeling, packaging and Instructions for Use documents
Obtain your original Declaration of Product Conformity certificate from Grosstandart and provide copies to distributors upon request
Present original Declaration of Product Conformity certificate on file and present to Russian customs if needed
Manage inquiries and responses for reportable events based on feedback from users, distributors or regulators
Serve as your point of contact with Russian authorities in the event of a product recall or withdrawal
Support recertification of your Declaration of Product Conformity (certificates are valid for one-, three- or five-year periods)

Clients may consider appointing their distributors to also serve as their Declarants in Russia, but there are significant drawbacks in doing so. Most distributors focus primarily on sales and marketing, not regulatory issues, which could affect their ability to inform you of significant market changes in Russia. Furthermore, conflicts of interest may arise between you and your distributor in the event of a device recall or incident report—will a distributor serving as your Declarant defend you our itself in such a case?

In addition, if you choose to designate your distributor as your Declarant and then decide to switch distributors, you will have to reprint all your labels, manuals and other relevant materials to reflect your new distributor/Declarant’s name.

Opting for an independent Declarant focused solely on supporting your device registration and compliance management ensures a smoother and more successful device marketing experience for you in Russia.