Russia Authorized Representative service for medical device companies
ANSWERED ON THIS PAGE:
- What are the responsibilities of a Russia Authorized Representative?
- What should we consider when choosing a Russian representative?
- Can we select a distributor as our RAR?
Foreign medical device manufacturers without a physical location in the Russian Federation must appoint a Russia Authorized Representative (RAR). The RAR is the liaison between your company and Roszdravnadzor (RZN). Your chosen representative is responsible for coordinating your medical device registration in Russia, is identified on your device labeling, and manages post-market vigilance activities.
The RAR is your company's regulatory advocate in Russia and authorized representative to supply details to the RZN, thus it is important to choose this partnership carefully.
What to consider when selecting your Russian medical device representative
Many medical device manufacturers think it is easier to appoint a distributor as their RAR. However, your Russian regulatory representative has a long list of responsibilities and a regulatory misstep could jeopardize your registrations with RZN. Your Russia Authorized Representative needs extensive regulatory expertise to best serve your company's interests. Here's why:
- At RZN's request, your RAR may need to provide confidential design and testing information about your device. Most manufacturers prefer to entrust this information to an independent firm (and not a distributor) to protect their intellectual property.
- RZN's medical device submission process is complex, opaque, and requires frequent communication with regulatory officials and industry agents. Your distributor may not have the resources or the expertise to resolve complications in the registration process.
- Your representative plays an important role in post-market vigilance and assists with your response strategy in the event of a recall or incident report. Distributors may not have the necessary experience with vigilance to identify the best course of action. Depending on the nature of the incident, your distributor may even have a conflict of interest.
- Russia medical device regulations change often and with little notice. Most distributors focus on sales and marketing, not regulatory updates. You want an RAR who stays informed about changes in their responsibilities, and informs you of new regulations that affect your devices.
Choose Emergo as your professional medical device Authorized Representative in Russia
Emergo Russia is the official in-country regulatory representative for more than 2,000 medical device and IVD companies worldwide. With a presence in Moscow, we can act as your independent RAR. In Russia's ever-evolving market, it is critical to have a partner who understands the environment and keeps you informed of regulatory updates to maintain compliance. As your officially designated representative in Russia, we will:
- Provide authorization to place the Emergo name and contact information on your device labeling
- Review your device labeling for compliance to RZN requirements
- Submit your registration submission to RZN and communicate on your behalf throughout the registration process
- Receive your Russia registration certificate from RZN and maintain a copy in case of inspection
- Provide information and documentation about your device to RZN upon request, with your written permission
- Act as a liaison between you and RZN for reportable events, incidents, or recall/market withdrawal. Analyze reportable events/incidents to determine the best course of action.
- Assist in registration changes or notifications to RZN
Appointing an experienced Russia Authorized Representative is an important factor to your success in Russia. We have the regulatory expertise to help you access this challenging medical device market.
Do we control our RZN registration if Emergo is our RAR?
The entity identified as owner on the Registration Certificate controls the device registration. If Emergo coordinates your Russia device registration, we will list the manufacturer as the owner. This may not occur if you appoint a distributor to handle your device registration.
Can we change our Russia Authorized Representative?
Yes. To change your RAR, you must execute and submit a new Power of Attorney and updated Labeling to RZN. You may also need to update your registration certificate if your current RAR is identified as the owner.