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Tag Archives: medicaldevices

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

Posted on Saturday June 27th, 2020 by smmproexpert

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

Fast track registration for products from special list

Posted on Thursday March 19th, 2020 by beawire

Expecting to have special registration process for some medical device products. Order of Russian Government 1416 latest updates bring these changes – for limited list of products: medical devices with 1 risk class are included in this list (for example, gloves), “fast track” includes initial submission with very limited amount of documents – with providing main dossier after registration certificate

MD regulation

About trials on the spot

Posted on Tuesday November 12th, 2019 by beawire

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

Lasers used in cosmetology

Posted on Tuesday November 5th, 2019 by beawire

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,

medicaldevices

Lost of accreditation.Who is next?

Posted on Friday November 1st, 2019 by beawire

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

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

Posted on Wednesday October 9th, 2019 by beawire

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

In vitro diagnosis of autoimmune diseases

Posted on Thursday October 3rd, 2019 by beawire

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

Classification of medical products – Order 4n

Posted on Monday July 22nd, 2019 by beawire

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

How testing should be provided according to 2n?

Posted on Friday July 19th, 2019 by beawire

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

Triclosan in the composition of medical products

Posted on Wednesday June 26th, 2019 by beawire

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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