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Basic regulatory documents in the sphere of medical device state registration in Russia 

NB: documents mentioned below are presented in Russian language

• Federal law No. 323-FZ dated December 27, 2012 "On the fundamental healthcare principles in the Russian Federation" 
  
• Decree of the Government of the Russian Federation No. 1416 of December 27, 2012 "On approval of medical devices state registration rules" 
  
• Order No. 4n of the Ministry of Health of the Russian Federation dated June 6, 2012 "On the approval of the nomenclature of medical devices"
  
• Order No. 7n of the of Ministry of Health of the Russian Federation dated June 15, 2012 "On approval of the procedure of medical devices import into the territory of the Russian Federation for the purpose of state registration"
  
• Order No. 2n of the Ministry of Health of the Russian Federation dated January 9, 2014 “On Approval of the Procedure for Medical Device Conformity Assessment in the Form of Technical Tests, Toxicological Testing and Clinical Trials for Medical Device State Registration Purposes”
  
• Order  No. 11n of the Ministry of Health of the Russian Federation dated January 19, 2017 "On approving the requirements to the content of technical and operational documentation of the medical devices producer (manufacturer)"
  
• Order No. 89n of the Ministry of Health of the Russian Federation dated August 15, 2012 "On approval of the procedure of testing for the purposes of type approval of measuring equipment, as well as a list of medical devices related to measuring equipment in the field of state regulation of ensuring the uniformity of measurements in respect of which the tests are conducted for the purposes of type approval of measuring equipment"
  

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