Category Archives: FAQ

How to find out if a medical device is registered or not?

Registration certificate (RC) is a document that confirms that a medical device can be used on the territory of the Russian Federation. The executive authority for monitoring and supervision in the field of organizing and ensuring the protection of public health is the Federal Service for Surveillance in Healthcare (Roszdravnadzor). All information about the registration process for a medical device

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Roszdravnadzor – how to use authority website?

The Federal Service for Surveillance in Healthcare (Roszdravnadzor) belongs to the executive authorities and performs control and supervisory functions in the field of organizing and ensuring the protection of public health. When registering medical devices (MD), Roszdravnadzor relies on the Decree of the Government of the Russian Federation No 1416 “On Approval of the Rulesr State Registration of Medical Devices”

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Features of increasing the shelf life of a medical device in case of making amendments to the registration documents

Introduction The shelf life of a medical device determines the period during which the product retains its functional properties and technical specifications established by the manufacturer. After the state registration of a medical device in the territory of the Russian Federation, the established value of the shelf life can be changed in accordance with the Decree of the Government of

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Free consultations (products intended to be used for coronavirus infection diagnostics)

Since March 20, 2020, due to the need to take measures for the non-proliferation of the Coronavirus infection (2019-nCoV), the Federal Service for Surveillance in the Sphere of Health of the Russian Federation (Roszdravnadzor or RZN) introduces special rules. These rules concern consultations about the registration of medical devices intended for the diagnosis of coronavirus infection (consultations in accordance with

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About trials on the spot

Note: This article does not apply to in vitro testing of medical devices for diagnostics, as in this case field trials (trials on the spot or so called factory audit for testing) are not applicable. Introduction Tests conducted for the purposes of the state registration of medical devices are regulated by Order No. 2n dated 09 January 2014 “On Approval

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Lost of accreditation.Who is next?

Technical testing and toxicological testing of medical devices should be carried out in a testing laboratory with the appropriate scope of accreditation. Information on the accreditation of the laboratory can be found in the general access on the website of the Federal Service for Accreditation (RusAccreditation). How to check the scope of laboratory accreditation: Visit the RusAccreditation website in the

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 Testing of a medical device for the purposes of marketing authorisation, particularly on-site visits as one of the testing methods

 Testing of a medical device for the purposes of marketing authorisation, particularly on-site visits as one of the testing methods. Marketing authorisation of medical devices consists of several steps, one of which is testing. Testing could be of three types, namely: Toxicology testing, Technical testing, and Clinical testing (trials) The procedure for the testing mentioned above is set forth in

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Classification of medical products – Order 4n

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION, ORDER dated 06 June 2012 No. 4n “ON APPROVAL OF THE NOMENCLATURE CLASSIFICATION OF MEDICAL DEVICES” – review. Appendix No. 1 to the Order on approval of the nomenclature classification of medical devices contains (please refer to Fig. 1) the numerical notation of the type of related medical device, i.e., a 6-digit unique identification

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How testing should be provided according to 2n?

 Order of the Ministry of Health of the Russian Federation (Minzdrav Rossii) dated 9 January, 2014 No. 2n “On Approval of the Procedure for Conformity Assessment for Medical Devices in the Form of Technical Testing, Toxicology Testing and Clinical Trials Performed for the Purpose of Marketing Autorisation of Medical Devices” (full text here). This procedure defines the requirements for conformity

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The article “Labeling of devices. Introduction

 1. Introduction The labeling of medical devices shall be a matter of crucial importance for the design, development, manufacturing and virtually every other phase of life cycle of medical devices, particularly during the operational period. However in real life, as one can see, manufacturers either do not duly care about label contents and description, or take every effort in order

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