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 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 as your Russia Declarant
Through our office in Moscow, Emergo 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 can provide the following services:
- Obtain your original Declaration of Product Conformity certificate from Grosstandart and provide notarized 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- or three-year periods)
Perils of choosing a distributor to fulfill this role
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 or itself in such a case?
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.
Please contact us for more information on appointing a Russia Declarant.