The Russian health agency Roszdravnadzor has published new regulations for medical devices. The regulations took effect on 1 January 2013. Medtechinsider is not yet familiar with the details of these regulations, are they only have been published in Russian.
The new medical device regulations were needed to make it easier for Russian medical device manufacturers to export their products, Sergey Tsyb, head of Department of Chemical Industries and Bioengineering Technologies within Russia’s Ministry of Industry and Trade, said in an interview with EMDT Editor in Chief Norbert Sparrow last year. Clarity and transparency for exporters were two major priorities for officials involved in reforming the regulatory system. The country plans to become a major player on the medical device market and recently approved a €4.5 billion investment programme in the medtech and pharmaceutical industries.
Last year, regulatory consulting firm Emergo Group detailed in a blog post what the new regulations would contain. The predictions were based on interviews with Russian Ministry of Health and Roszdravnadzor officials. The firm predicted that the new regulations will reduce the regulatory role of Roszdravnadzor and that final product approvals will be made by reviewers outside the regulator. You can read more about what may be included in the new regulations in the blog post on Emergo Group’s website.