Revised regulations for the Russian medical device market have been in effect since January 1, 2013, and Emergo Group has now learned more details of these changes, although some specifics of the new rules are still needed.

All medical device registrations submitted to Russian medical device market regulator Roszdravnadzor after January 1, 2013 will fall under the new requirements; applicants seeking registration under the previous regulations must provide a written statement to Roszdravnadzor as soon as possible.

Registration Certificates
Medical device registration certificates obtained before January 1, 2013 will remain valid until their expiration dates. Registration certificates for devices approved prior to the new regulations that have no expiration date remain valid until January 1, 2014, at which point affected manufacturers will have to submit official statements to Roszdravnadzor requesting replacement of registration certificates. (These manufacturers will not have to re-register their devices, according to the new regulations.)

The following information will be included in Registration Certificates going forward:

Authorized Representation Requirements
The new regulations define an Authorized Representative as a legal entity registered in the Russian Federation and representing a medical device manufacturer in regulatory issues including conformity assessments and registration. This marks the first time Russian regulators have officially introduced authorized representation requirements.

Registration and Testing
Testing results still play a large role in Russia’s medical device registration process. The new regulatory system adds additional testing requirements for measuring devices. It remains unclear, however, whether regulators will require clinical testing for all risk classes, or whether regulators will accept clinical test results from internationally accredited laboratories.

Use of Expertise Centers
One of the more significant changes in the revised regulations has to do with the larger role “Expertise Centers” will play in the Russian medical device registration process.  These entities will determine whether registrants must conduct clinical trials in Russia for their devices, as well as whether devices under review are safe enough to undergo clinical testing in Russian healthcare facilities. In addition, Expertise Centers—rather than Roszdravnadzor officials—will evaluate registration dossiers for quality, safety and efficiency, which will influence Russian regulators’ final decision whether to approve a registration application. Thus, foreign manufacturers seeking market authorization in Russia should prepare to deal with multiple entities, not just Roszdravnadzor, to register their devices.

Bottom line: Less Opaque, More Complex
With a revised regulatory process now in place, medical device registration in Russia still remains a complex endeavor. But now that we have a more detailed playbook, so to speak, of what to expect in terms of Roszdravnadzor requirements, medical device companies may ultimately benefit in terms of a more predictable (if not easy) path to market in Russia. Emergo Group will provide additional information on regulatory changes in Russia as we learn them.