Tag Archives: faq

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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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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