Russia is expected to release new medical device regulations within the next few weeks, according to the Massdevice website. The article states that the new regulations will be clearer and have more specific requirements than current ones (e.g., by providing reporting timelines and requirements for post-approval reporting). The updated regulations are also expected to cover the clinical trial process, with components such as requirements for ethics committee reviews and patient agreements.
The new regulatory requirements may be part of Russia's plan to become a major player on the medical device market. In an interview last year (see Russia Seeks Parity with Leading Medtech Economies by 2020), Sergey Tsyb, who heads the Department of Chemical Industries and Bioengineering Technologies within Russia's Ministry of Industry and Trade, mentioned that the country wants to streamline regulatory requirements in order to make it easier for Russian medical device manufacturers to export their products. Whether the regulations will make it easier for foreign companies operating in Russia to navigate the regulatory system remains to be seen.
For more on medical device regulations in general and Russia specifically, take a look at the following:
- Medical device regulatory processes for 10 countries
- Clinical Trial Supply Challenges in China, Russia, Brazil & the Ukraine
- E-labeling medical devices for the EU market
ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.