Regulatory Landscape Changes in Russia

Russian regulators have reportedly implemented the much awaited changes to the nation's regulatory process for medical devices, and the revised regulations took effect at the start of January. This follows a highly positive recent report about the general state of clinical research in Russia in a leading US peer-reviewed cardiac journal.

The medical device regulator, Rozsdravnadzor (Federal Service on Surveillance in Healthcare and Social Development of Russian Federation), has devised new procedures for testing sample import permits, as well as expert device reviews and clinical testing requirements, according to Stewart Eisenhart, who covers medical device regulatory affairs for the Emergo Group.

A significant change in the revised regulations concerns the larger role "expertise centers" will play in the Russian medical device registration process. These centers 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, he explained in an article posted on the Emergo website on January 15. They will evaluate registration dossiers for quality, safety, and efficiency, which will influence the regulators' final decision about whether to approve a registration application, so foreign companies seeking market authorization in Russia should prepare to deal with multiple entities, not just Roszdravnadzor.

"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," noted Eisenhart.

For the first time, Russian regulators have officially introduced requirements for authorized representation. They 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.

Testing results will still play a large role in Russia's medical device registration process, he stated. The new regulatory system adds extra testing requirements for measuring devices, but it remains unclear whether regulators will require clinical testing for all risk classes or whether they will accept clinical test results from internationally accredited laboratories.

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

Meanwhile, Anthony N. DeMaria, MD, Editor-in-Chief of the Journal of the American College of Cardiology, has issued an upbeat report about clinical research in Russia. "The implications of my Russian experience were particularly impressive for clinical research," he wrote in an editorial in the December issue. "The channeling of clinical volume, such as into the Moscow City Center, provides an excellent opportunity for clinical investigation."

DeMaria notes that large, impactful trials now draw up to 80% of patients from countries outside of the industrialized world, and he thinks the trend toward an increasing amount of clinical research being performed in emerging markets will continue. The incremental benefit of many therapies is often modest enough that large sample sizes are required to determine benefit, and many study sites are necessary, he maintains. Also, the cost of research is much less in developing countries, especially since enrollment is usually more rapid and thus the duration of the trial is shortened, and the regulatory environment outside the United States is often less demanding.

Based on his experiences in Moscow, it is clear that centers with contemporary technology and expertise do exist. Cardiovascular patients in these centers are managed in a standard fashion according to existing guidelines by knowledgeable and skilled physicians using up-to-date pharmaceuticals, supplies, and equipment, and patients can be enrolled in studies with the expectation that the results observed can be extrapolated to a general population, DeMaria concluded.

—Philip Ward