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俄羅斯RZN醫(yī)療器械國(guó)家注冊(cè)復(fù)雜、繁瑣，細(xì)節(jié)內(nèi)容以及前提條件對(duì)于很多企業(yè)來(lái)說(shuō)不透明也不清晰。

 

1.前言

 

俄羅斯醫(yī)療器械市場(chǎng)是一個(gè)很廣闊并有機(jī)會(huì)的市場(chǎng)，但是俄羅斯醫(yī)療器械和體外診斷試劑及器械所要求的各種法律、法規(guī)、指令、條例眾多，對(duì)于國(guó)內(nèi)廠商來(lái)說(shuō)不透明。

 

2.俄羅斯醫(yī)療器械監(jiān)管之各種條款

 

Resolution of the Government of the Russian Federation of 30.11.2024 No. 1684 

 

On approval of the Rules for state registration of medical devices

 

Order of the Ministry of Health of Russia dated 08/30/2021 No. 885n

 

On approval of the Procedure for conducting conformity assessment of medical devices in the form of technical tests, toxicological studies, clinical trials for the purposes of state registration of medical devices

 

Methodological recommendations from 03.06.2024

 

on the procedure for conducting an examination of the quality, efficiency and safety of medical devices for in vitro diagnostics for state registration, including in the event of their defect or risk of defect, registration of a series (batch) of medical devices for in vitro diagnostics

 

Order of the Ministry of Health of Russia dated 02.05.2023 No. 201n

 

On approval of the Procedure for importing medical products into the territory of the Russian Federation for the purposes of state registration

 

Order of the Ministry of Health of Russia dated 06.06.2012 No. 4n

 

On approval of the nomenclature classification of medical devices

 

Order of the Ministry of Health of Russia dated 07.07.2020 No. 686n

 

On Amendments to Appendices No. 1 and No. 2 to the Order of the Ministry of Health of the Russian Federation dated June 6, 2012 No. 4n "On Approval of the Nomenclature Classification of Medical Devices"

 

Methodological recommendations on the procedure for conducting an examination of the quality, efficiency and safety of medical devices (in terms of software) for state registration within the framework of the national system from 07.05.2024

 

approved by the Federal State Budgetary Institution "National Institute of Quality" of Roszdravnadzor and the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor

 

Federal Law of the Russian Federation of 13.03.2006 No. 38-FZ

 

About advertising (as amended on 12/05/2022)

 

Resolution of the Government of the Russian Federation of 30.06.2004 No. 323

 

On approval of the Regulation on the Federal Service for Surveillance in Healthcare (as amended on 13.10.2022)

 

Federal Law of the Russian Federation of 21.11.2011 No. 323-FZ

 

On the Fundamentals of Health Protection of Citizens in the Russian Federation (as amended and supplemented, effective from 11.01.2023) (as amended on 28.12.2022)

 

Federal Law of 27.12.2002 No. 184-FZ

 

On technical regulation (as amended on 02.07.2021)

 

Order of the Ministry of Health of Russia dated 15.08.2012 No. 89n

 

On approval of the Procedure for conducting tests for the purpose of approving the type of measuring instruments, as well as a list of medical products related to measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, in relation to which tests are conducted for the purpose of approving the type of measuring instruments

 

Resolution of the Government of the Russian Federation of September 30, 2021 No. 1650

 

On approval of the Rules for maintaining the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, on amendments to the list of regulatory legal acts and groups of regulatory legal acts of the Government of the Russian Federation, regulatory legal acts, individual provisions of regulatory legal acts and groups of regulatory legal acts of federal executive bodies, legal acts, individual provisions of legal acts, groups of legal acts of executive and administrative bodies of state power of the RSFSR and the USSR, decisions of the State Commission on Radio Frequencies containing mandatory requirements in respect of which the provisions of Parts 1, 2 and 3 of Article 15 of the Federal Law "On Mandatory Requirements in the Russian Federation" do not apply, as well as on recognizing as invalid certain acts of the Government of the Russian Federation

 

Order of Roszdravnadzor dated 19.05.2022 No. 4282

 

On approval of the Regulation on the interdepartmental commission for the formation of a list of types of medical products subject to circulation in accordance with the Peculiarities of circulation, including the specifics of state registration, of medical products in the event of their defect or the risk of defect in connection with the introduction of restrictive economic measures in relation to the Russian Federation, approved by Decree of the Government of the Russian Federation of April 1, 2022 No. 552 (registered with the Ministry of Justice of Russia on May 26, 2022 No. 68599)

 

Resolution of the Government of the Russian Federation of 03.04.2020 No. 430

 

On the specifics of circulation of medical devices, including state registration of a series (batch) of a medical device (as amended on 28.12.2021)

 

Resolution of the Government of the Russian Federation of 16.11.2020 No. 1847

 

On approval of the list of measurements related to the sphere of state regulation of ensuring the uniformity of measurements

 

Resolutions of the Government of the Russian Federation dated 13.11.2020 No. 1826

 

On Amendments to the Resolution of the Government of the Russian Federation of April 3, 2020 No. 430 and on the Replacement of the Registration Certificate for a Series (Batch) of a Medical Device

 

Order of the Ministry of Health of Russia dated 19.05.2023 No. 245n

 

On approval of the Regulation on the organization of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation and the provision of medical care within the framework of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation (including the procedure for referring patients for the provision of such medical care), a standard form of the protocol for clinical testing of methods of prevention, diagnosis, treatment and rehabilitation

 

Resolution of the Government of the Russian Federation of 30.06.2021 No. 1066

 

On federal state control (supervision) over the circulation of medical devices (as amended on 07.12.2021)

 

Order of the Ministry of Health dated 19.01.2017 No. 11n

 

On approval of requirements for the content of technical and operational documentation of the manufacturer (producer) of a medical device (as amended on 22.04.2019)

 

Law of the Russian Federation of 07.02.1992 No. 2300-1

 

On consumer protection