Legislation

OTHER DOCUMENTS:

• AGREEMENT On the Uniform Principles and Rules Governing Market Circulation of Medical Devices within the Eurasian Economic Union (as of December 23, 2014)
• EUROPEAN COMMISSION DG HEALTH & CONSUMERS

FEDERAL LAWS:

• Federal Law 323 "On the Fundamentals of Health Protection in the Russian Federation"

GOVERNMENT RESOLUTIONS:

• Government Resolution #1517 as of December 30, 2015 "On Governmental Price Regulation for Medical Devices Implantable into the Human Body as Part of Medical Aid Provided to Citizens under the Program of State Guarantees of Free Medical Care for Citizens"
• Government Resolution as of February 5, 2015 No. 102 "On Establishing Market Entry Restrictions for Individual Types of Medical Devices Originating from Foreign Countries in the Context of Procurement for State and Municipal Needs"
• Government Resolution as of June 19, 2012 No. 615 "On approval of the rules of maintaining the state register of medical products and medical product manufacturers/makers"
• Government Resolution №1416 as of December 27, 2012 "On Approval of the Rules for State Registration of medical devices"

MINISTRY OF HEALTH ORDERS:

• Order of the Ministry of Health of the Russian Federation as of June 6, 2012, No. 4n "On approval of the medical devices nomenclature classification"
• Order of the Ministry of Health of the Russian Federation as of June 15, 2012, No. 7n "On approval of the procedure for import of medical products to the Russian Federation for state registration"
• Order of the Ministry of Health of the Russian Federation as of June 20, 2012, No. 12n "On approval of the procedure for disclosure by pharmaceutical entities of all instances when the side effects not specified in the medical product leaflet / user manua
• Order of the Ministry of Health of the Russian Federation as of August 15, 2012, No. 89n "On approval of the testing procedure to establish the types of metering devices and the list of medical products classified as metering devices in state regulation o
• Order of the Ministry of Health of the Russian Federation as of September 14, 2012, No. 175n "On approval of the medical product safety monitoring procedure"
• Order of the Ministry of Health of the Russian Federation as of December 20, 2012, No. 1181n "On approval of the procedure for prescribing and administering medical products as well as of prescription templates for medical products and the procedure for i
• Order of the Ministry of Health of the Russian Federation as of December 21, 2012, No. 1353n "On approval of the procedure for medical product quality, efficacy and safety review"
• Order of the Ministry of Health of the Russian Federation as of February 8, 2013, No. 58n "On approval of the regulations on the ethics board in circulation of medical devices"
• Order of the Ministry of Health of the Russian Federation as of April 9, 2014, No.2n "On Approval of the Procedure for Medical Device Conformity Assessment in the Form of Technical Trials, Toxicological Studies and Clinical Trials for Medical Device State