The Russian medical device market can be a smart move for medical device manufacturers. Between the size of the market and the low saturation of imports on the market, some medical device manufacturers may find that it is worth the additional regulatory approval to sell their devices in Russia.
In 2013 the Russian medical device regulations were revised to include some new actors and a new procedure for medical device market approvals. This new regulation streamlined and made the process a bit more transparent than it was previously. Since the new regulation was implemented, the medical device import market in Russia has grown immensely. We’ve broken down the Russian medical device approval process into six broad steps. If a medical device manufacturer is interested in marketing their device in Russia, they should consult the text of the Russian medical device regulations. However, these six steps can provide a framework and initial understanding of those regulations.
Step 1: Find your Authorized Representative.
Similar to the EU, foreign manufacturers need to find an Authorized Manufacturer’s Representative in Russia to both submit your registration and interface with Roszdravnadzor. Roszdravnadzor is the Russian medical device regulator, responsible for market access and surveillance for the Russian medical device market. The AR needs to be a separate legal entity from the legal manufacturer, so a manufacturer may not be able to simply use their Russian office.
Step 2: Technical and Biocompatibility Testing.
A manufacturer sends samples of their device to be tested by an accredited laboratory in Russia, after receiving special importing permission from Rozdravnadzor. These technical and biocompatibility tests are done to test the conformity of the device to the corresponding Russian GOST standards. Biocompatibility, or toxicology, testing is required for all implantable medical devices or accessories, and all devices or accessories that would come into contact with the patient or user.
Step 3: Compile the Technical Documentation.
Once the manufacturer has the results from the technical and biocompatibility tests, they can start to compile the technical documentation. Russia’s technical documentation requirements are harmonized with the GHTF STED requirements. The manufacturer should make sure that their information is as complete as possible, as questions later on can stop the clock on their regulatory review.
Step 4: Roszdravnadzor reviews submission.
When the technical documentation is complete, the manufacturer and the authorized representative send the required documentation to Roszdravnadzor. At this point, Roszdravnadzor checks the submission to ensure that it is complete and that it contains all the pieces of information that are needed to assess the device according to the regulatory requirements. Once it is complete, Roszdravnadzor sends the submission over to an accredited third party review body.
Step 5: Third party reviews submission.
The third party review can also be called the “expertise” review, as it is the third party that reviews the substance of the submission. This third party will review the submission’s technical, scientific, and engineering information to see if the device meets the regulatory requirements for health and safety. As part of this review, the third party body will determine if the device falls within the definition of a medical device according to the Russian regulations, verifies its classification, etc. At this point, the third party could determine that the device does not meet the regulatory requirements, or that it does meet the regulatory requirements, or that more information is needed from the manufacturer.
Step 6: Clinical evaluation/investigation.
Roszdravnadzor requires a hospital or clinical trial site in Russia to perform a clinical evaluation or investigation on the device before it is fully approved. The manufacturer still needs to submit clinical information with their device submission, but the entity in Russia will perform an additional clinical evaluation or investigation, depending on the type or riskiness of the device. The output of this study is then reviewed by the third party body. If the third party body approves, then the submission is sent to Roszdravnadzor for their final approval.
Like many of the world’s regulatory schemes, the Russian medical device regulatory approval process has many actors and moving parts. However, keeping these six broad steps in mind can help to build the foundation of a strategy for a medical device manufacturer looking to enter the Russian market.