Regulatory control of medical device circulation in the Russian Federation
Verkaufspreis Inland (inkl. MwSt.)
The regulatory authority in Russia, Roszdravnadzor, has authored an article on the issues surrounding market access of medical devices in the Russian Federation, both at a national level and within the Eurasian Economic Union. The article summarises the two systems for medical device and IVD registration that currently exist, including confirmation of quality, safety and effectiveness, and testing procedures. The article also looks at future plans for regulatory changes.
Specification: 12 pages plus covers, in English, supplied by email as a PDF. This article has been published previously in the Journal of Medical Device Regulation.
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