The Federation of Russia, spanning nine time zones and sharing borders with 16 countries, is one of the most resource-rich regions in the world. Ranked as the tenth highest economy according to GDP and sixth largest according to PPP, it is considered one of the fastest growing economies. Although medical device spending per capita remains low in comparison to the European or US markets, the Russian medical device market is among the top 20 in the world.
However, health indicators in Russia remain imbalanced. While there are more doctors and health facilities per person than most countries in the world, average life expectancy remains relatively low among developed nations with the leading causes of death being cardiovascular disease and cancer. Following the collapse of the Soviet Union, Russia’s universal healthcare system has undergone several reforms with varying success.
The registration of medical devices in Russia is considered somewhat complicated. Although efforts have been made to simplify the process through new rules for medical device registration that came into force on January 1st, 2013, there are still areas of ambiguity.
THE GOOD NEWS:
Licenses for medical devices in Russia no longer carry an expiry date, barring changes to the device.
THE GREAT NEWS:
The significant costs and time-to-market are decreased through professional consultation.
Generally, the quality of Russian products is average to low when compared to equivalents in other major regions and there are often no Russian-made products analogous to high-end equipment elsewhere.
In 1998, a number of Russian medical equipment and device manufacturers took advantage of a sharp rise in the price of important medical equipment caused by an economic crisis, increasing their share of the total market. However, in general, imported medical equipment and supplies still play a major role and currently make up 71% of the total market share. Germany, the USA, and Japan were the leading suppliers of medical devices in Russia in 2007, accounting for more than half of all imports.
In 2006, the Russian government initiated the Priority National Program in Public Health Service, which aims to improve Russian healthcare standards along with a regulatory process that was overly bureaucratic, complex, and lacked transparency. In 2013, a new registration process for medical devices was introduced.
The most challenging part of the registration process is the fact that devices that carry a CE Mark or FDA 510(k) clearance must still be tested according to Russian standards. Required testing includes technical tests, safety evaluation, toxicology tests, electromagnetic tests, and others. Russia classifies devices according to the EU classification model (Class I, IIa, IIb, and III).
According to new legislation, the registration process usually takes 85 working days, depending on the required tests and approvals. However, clinical test are not included in this time-frame and, consequently, it may be extended to as much as 300 working days. The final price is usually between USD $3000 and USD $4000 for medical supplies or disposable equipment and up to $10 000 or more for more high-end technical equipment.
Whereas licenses used to expire after ten years, once registration has been completed, they are now valid in so long as no changes are made to the following: product quality, efficiency, or safety; side effects or use limitations; manufacturer’s name or rights to the device; produce trade name; packaging; or documentation for registration. If changes are made, the device must be re-submitted as if it were a new device.
Additionally, all document and certificates must be in Russian. Official documents must also be notarized and legalized.
Due to the complexity of the registration process in Russia, we recommend that submission be carried out by professionals with high familiarity with the Russian system and Russian language. In doing so, time-to-market and costs can be cut significantly.
WHAT YOU NEED TO KNOW:
Changes to the registration process in Russia came into effect on January 1st 2013, increasing cost, time-to-market, and some requirements. However, licenses no longer need to be renewed unless changes are made to the device and the registration process is considerably eased through professional regulatory consultation.