Regulatory framework of medical devices circulation in the Russian Federation

(documents are presented in Russian)

1

 

Resolution of the Government of the Russian Federation of February 10, 2017 No. 160

On amendments to Resolution of the Government of the Russian Federation of December 27, 2012 No. 1416 


2

 

Federal law of the Russian Federation of November 21, 2011 № 323-FZ

On the basical principles of health protection in the Russian Federation (as amended on July 03, 2016) 


3

 

The Order of the Ministry of Health of Russia of October 14, 2013 № 737n

About approval of Administrative regulations of Federal service for supervision in the sphere of health care of public services on state registration of medical devices

 

4

 

Resolution of the government of the Russian Federation of June 30, 2004 № 323

On approval of the Regulations on the Federal service for supervision in the sphere of health care (ed. by December 27, 2014) 


5

 

The Order of Ministry of Health of Russia of December 21, 2012 № 1353n

On approval of the Procedure of organization and carrying out of examination of quality, efficacy and safety of medical devices


6

 

The Order of the Ministry of Health of Russia of June 03, 2015 No. 303n

On amendments to the Order of Ministry of Health of the Russian Federation of December 21, 2012 1353n N "On approval of the Procedure of organization and carrying out of examination of quality, efficacy and safety of medical devices” 


7

 

The Order of the Ministry of Health of Russia of June 06, 2012 № 4n

On approval of the nomenclature classification of medical devices 


8

 

The Order of Ministry of Health of Russia of January 09, 2014 No. 2n

About approval of the Procedure for the conformity assessment of medical devices in the form of technical tests, toxicological research, clinical tests for the purpose of state registration of medical devices 


9   

 

Resolution of the Government of the Russian Federation of June 19, 2012 № 615

About approval of Rules of maintaining the state register of medical devices and organizations (individual entrepreneurs) engaged in production and manufacturing of medical devices


10   

 

The Order of the Ministry of Health of Russia of August 15, 2012 № 89n

On approval of the Procedure of testing for the purposes of type approval of measuring instruments, as well as a list of medical devices related to measuring instruments 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 instruments 


11

 

The Order of Ministry of Health of Russia of February 21, 2014 No. 81n

On approval of the List of the measurements relating to the sphere of state regulation of ensuring unity of measurements when implementing activities in the field of healthcare, and compulsory metrological requirements for them, including indicators of accuracy of measurements 


12

 

The Order of the Ministry of Health of Russia of June 20, 2012 № 12n

About approval of the Procedure of notification of medical devices circulation subjects about all cases of revealing of the side effects not specified in the instructions for use or user manual of a medical device, about undesirable reactions at its application, about features of interaction of medical devices among themselves, about the facts and the circumstances creating threat of life and health of citizens and health care workers at application and operation of medical devices 


13

 

The Order of the Ministry of Health Russia of May16, 2013 No. 300n

On approval of the requirements for medical organizations conducting clinical trials of medical devices, and order to establish compliance of medical organizations to these requirements 


14

 

The Order of the Ministry of Health of Russia of June 15, 2012 № 7n

On approval of the Procedure of medical devices import into the territory of the Russian Federation for the purpose of state registration 


15

 

The law of the Russian Federation of February 07, 1992 № 2300-1

On the protection of consumers rights 


16

 

Federal law of the Russian Federation of November 25, 2013 № 317-FZ

On amendments to certain legislative acts of the Russian Federation and invalidating certain provisions of legislative acts of the Russian Federation on health protection of citizens in the Russian Federation


17

 

Federal law of the Russian Federation of December 27, 2002 № 184-FZ

On technical regulation


18

 

Federal law of the Russian Federation of March 13, 2006 № 38-FZ

On advertising 


19   

 

Resolution of the Government of the Russian Federation of December 27, 2012 № 1416

About approval of Rules of medical devices state registration



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