Medical Device and IVD Registration in Russia
ANSWERED ON THIS PAGE:
- What are the medical device registration requirements in Russia?
- How do we determine Russian testing and clinical requirements for our medical device?
- How are medical devices classified in Russia?
Russia presents a potentially lucrative market for medical device companies. However, the registration process can be a challenge. Unlike most countries, Russia still relies on in-country testing and clinical data to approve medical devices, even if the device is already sold in other major markets.
With an office in Russia, Emergo stays ahead of regulatory changes and can help you navigate Russia's complex regulatory process.
Russia medical device registration requirements
Medical devices in Russia are regulated by Roszdravnadzor (RZN) under Resolution 1416. You must register your device with RZN prior to selling or distributing your product. Manufacturers must address substantial regulatory requirements, including:
- preparing a technical file in Russian,
- conducting local testing, and
- submitting supplemental Russian clinical data.
Roszdravnadzor reviews your regulatory submission in two stages. In the first stage, RZN performs a completeness review of your documentation before sending it to an Expertise Center. The Expertise Center will recommend the type of clinical data necessary for your device. RZN will then make the final decision regarding the possibility of your application to procced to stage two.
After you receive a positive response from RZN, you will perform the additional testing and/or clinical trials necessary for your device. You will then resubmit your application to RZN for the stage two review. Once RZN and the Expertise Center approve your application, RZN will issue your Registration Certificate.
Class I manufacturers submit their Russian clinical data in their initial application, and only require one stage of reviews.
For an in-depth overview of the Russia regulatory approval process for medical devices, download our approval process chart that explains how the process works, how long it will take, and
Medical device testing and clinical data requirements in Russia
In-country testing and clinical data are the cornerstones of the Russian regulatory process. All manufacturers must test their device in Russia through an officially approved laboratory. Foreign test reports are not accepted, even if the testing was conducted through an internationally recognized lab.
In addition to local testing, all classes of devices require supplemental Russian clinical data. The types of clinical data Roszdravnadzor could require include:
- Additional clinical testing and evaluation of the device in a Russian hospital;
- Human participation clinical trials in Russia (not required for Class I); and/or,
- Preparation of a clinical evaluation report by an approved Russian laboratory.
If your device is novel or high-risk, Roszdravnadzor may require human participation clinical trials conducted in Russia.
Our team can help you with medical device registration in Russia
Navigating Russian bureaucracy and language without the assistance of an experienced local representative can be frustrating. Emergo has the necessary contacts in the Russian market to assist you with all aspects of medical device and IVD company registration in Russia. Here's how we can help:
- Advise on classification and family grouping of your medical devices in the Russian Federation.
- Coordinate with accredited testing labs within Russia on identifying required product testing and coordinating shipment of product samples to these facilities.
- Prepare technical file and registration application according to Russian regulations.
- Coordinate translation of the registration dossier and other technical documents into Russian.
- Submit application to Roszdravnadzor and assist with post-submission activities.
- Coordinate testing, application, and registration fees.
- Assist with supplemental clinical data requirements according to Roszdravnadzor's requirements.
- Liaise with Roszdravnadzor as your Russia Authorized Representative.
Emergo's global regulatory experts can help you with medical device market access in Europe and markets worldwide.
Frequently asked questions
How are medical devices classified in Russia?
The first step to medical device market access in Russia is classifying your medical device. Determine classification and nomenclature classification code according to Order 4n, amended by Order 557n, and GOST 51609-2000. There are four classification tiers for medical devices and IVDs: Class I, IIa, IIb, and III.
Registration requirements vary slightly depending on your device classification, especially for Class I devices.
What is the Eurasian Medical Device Registration Rules?
In January 2016, the Eurasian Economic Commission (ECC) released a new regulatory system for medical devices, the Eurasian Medical Device Registration Rules (ERR). The ERR is intended to harmonize the requirements between countries and establish a common market, similar to the EU's CE Marking system.
As a member of the ECC, Russia is expected to slowly transition to the new system. The current deadline for all products to be registered under the ERR is currently December 31, 2021. However, the practical elements of this new system are unclear. As a result, companies are still pursuing registration through Resolution 1416 at this time.