Tag Archives: Head

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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Botulinum toxin – poison or drug?

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

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

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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Import of samples for declaration of perfumery and cosmetic products

Declaration of perfumery and cosmetic products on the territory of the customs union becomes a difficult task for foreign manufacturers. In particular, it is a question of import of samples to the territory of the Russian Federation. Just a few months ago, it was possible to use any samples on the hands for declaration purposes. However, everything has changed since

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Silicons in cosmetics, drugs and medical devices

Nowadays, we can often hear that certain cosmetic products do not contain parabens and silicones. About what parabens are, what they are used for and how dangerous they are, you can read here. As for silicones, they are widely used in pharmaceutical, cosmetic and food industries, as well as in medical practice. Since 2002, approximately 470,000 tons of silicones have

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Approvals for drugs

Our new topic about drugs regulation: what are drugs and how to determine it from borderline products? how to receive state registration and permission for clinical trials? what actions are required for pharmaceutical substance? Find answers in our new big topic – by link.

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Medical devices that include components of animal origin

 An extensive group of medical devices (MDs) includes completely different products that may include different components. In the section devoted to MD, articles about drugs as part of MD have been published more than once (here and here). However, in addition to medicinal substances, various components of animal origin can be included in MD. Product overview Among the MD, which

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