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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The invention of the laser became one of the most important and significant achievements of the twentieth century. Currently laser technologies are used in almost all spheres of life: science, armaments, industry, etc. Lasers are also widely used in medicine, one of the areas of which is cosmetology. A laser is a device that converts pumping energy (light, electrical, thermal,
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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. 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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Autoimmune diseases (AID) develop in cases where antibodies (AT) or T cell clones are present in the body, directed against the body’s own antigens (AG). Autoimmune mechanisms are at the heart of many organo-specific and systemic diseases. These diseases include rheumatoid arthritis, insulin-dependent diabetes mellitus, ulcerative colitis and other less known diseases. The resulting autoimmune process is usually chronic and
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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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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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Not so long ago on our site there were published several articles devoted to the most sensational categories of substances, which are often included in cosmetics and medicines, as well as in medical devices and raise disputes among consumers, manufacturers, environmentalists and other communities. (Read more about this in the articles about parabens and silicons). Triclozan is also the subject
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Which problems photonics regulation has? By link – article from magazine about current situation in this area. Main players in medical device area from photonics are lasers and issues about labels for them are popular.
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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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