1. The Federal law "About bases of health protection of citizens in the Russian Federation of 21.11.2011 N 323-FZ (as amended on 25.06.2012)
2. Technical regulations of the Russian Federation "On safety of medical products"
Технический регламент Российской Федерации «О безопасности изделий медицинского назначения»
3. Resolution of the Government of the Russian Federation from December 27, 2012 No. 1416 On approval of Rules for state registration of medical products" (with changes and additions)