Author Archives: beawire

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

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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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Skin aging and UV radiation

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For many people, it sounds strange, but the skin is the biggest organ of our body, which is exposed to the strongest environmental impact every day. During life, the skin accumulates various lesions and therefore is a visual “aid” for aging of the human body. Skin aging at this stage of evolutionary development is an inevitable process, but someone manages

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In vitro diagnosis of autoimmune diseases

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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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Orphan diseases

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According to the All-Russian Society of Orphan Diseases, about 30 million patients with rare diseases were registered in the European Union. This means that every 15th European suffers from one or another orphan disease. The figures are impressive, given that the synonym for orphan diseases is “rare diseases”. Federal Law 323 states that orphan disease is a disease the prevalence

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Classification of medical products – Order 4n

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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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How testing should be provided according to 2n?

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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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Botulinum toxin – poison or drug?

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Not so long ago it became known that the American biopharmaceutical company AbbVie became the lucky owner of the Irish manufacturer of drugs Allergan. According to the representative of AbbVie, this acquisition will allow the company to focus on the development of new drugs without compromising the business. Allergan’s portfolio includes drugs for the treatment of ophthalmic, neurological and gastrointestinal

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Triclosan in the composition of medical products

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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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Reference, generic and biosimilar drugs

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As part of the consideration of the procedure for registration of medicines it is worth paying attention to such groups of drugs as reference (= Brand name), generic and biosimilar drugs. According to statistics, more than 60% of drugs on the Russian market are generics, or reproduced drugs. Definitions According to the Federal Law 61 reference drug is called a

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