Our company has been rendering medical registration services for 16 years. During this period, we have accumulated a large amount of knowledge and acquired exclusive skills in this area. We have worked out a number of unique tools, which help us to speed up the procedure, bring the terms closer and simplify the process of registration. Our specialists have developed a number of techniques that allow to thoroughly study the materials and promptly prepare the documents.
Thanks to this, the procedure is transparent for the customer and the service price is stable. Our attentive experts are loyal to customers. They are going to provide you with detailed explanations of all the points concerning the specifics of the product and the registration procedure as a whole. They are inventive in non-standard situations and are capable to perform a concept-oriented job in order to hit the primary goal - obtaining the registration certificate of Federal Supervisory Agency for Health Care and Social Development (Roszdravnadzor).
THEN, it's us whom you can fully rely on!
What do we mean?! We mean that we are ready to support you at any stage of the registration procedure: from preparing a registration dossier and working with notices till obtaining a registration certificate. You just prepare your own documents, we examine them and identify shortcomings, which you can safely remove subsequently. With all this, we energize you with powerful consulting support, which gives you:
Everybody knows that one needs to work hard to register a medical product. This is a process, in which science and practice are mixed, and it stands for reason that only domain specialists should work in there. The only question is: how to determine whether the company, which undertakes to conduct the registration procedure for your medical product, possesses the required competence. The sad truth is that, sometimes, non-professionals set to this job, thirsting for profit and feeling no responsibility, and, for the manufacturer, this way means a loss of time, money, decrease in sales and all the beauties that come out of it.
We have repeatedly faced customers, who were emotionally devastated, embittered, exhausted - and they got reasons for this. In such cases, the Law in our country should protect every manufacturer, who has already invested a lot of money into the development of an innovative product. We have already a practice of legal protection of manufacturers from unfair partners. Our forceful principled lawyer is adapted to such cases. He masterfully achieves the intended goal, because he is assisted by a separate team of professional consultants specialized in the matters of registration of medical products.
Being together, we will get justice and will not let you be swindled!
For the special benefit of manufacturers of medical products and their representatives, our company has developed a series of thematic events on the procedure for registration of medical products. Thanks to the knowledge gained, a specialist of YOUR COMPANY will be able to collect the necessary package of documents without exterior help and go through the registration procedure independently. In our classes, sequentially, we will delve into all the steps of the procedure for registering medical products, beginning with the collection of initial documents and ending with the its submission to the registration authority.
One registration certificate can conclude medical products belonging to various types, provided that the classification features of the type of the medical product indicated depending on the purpose of the medical product are not violated, specifically:
- Application area;
- Frequency of usage (single or multiple application);
- Operating features;
- Design features.
Moreover, the registered products should have a single National product classification code (later OKP code) in accordance with the All-Russian Classification of Products OK 005–93 approved by resolution No.301 of Gosstandart of Russia dated 30.12.1993.
Scientific (research) activity is regulated by Federal Law No.127–FZ “On Science and State Scientific and Technical Policy” dated 23.08.1996.
Products designed only for the scientific research by the manufacturer are not medical and are no subject to the official registration as medical products under the provisions of Federal Law No.323–FZ “On Fundamental Healthcare Principles in the Russian Federation” dated 21.11.2011.
Consequently, the issues of the import procedure and circulation of the products for scientific research in the territory of the Russian Federation are beyond the competence of Roszdravnadzor.
In accordance with Federal Law No.323–FZ paragraph 1 Section 38 “On Fundamental Healthcare Principles in the Russian Federation” dated 21.11.2011, any tools, devices, apparatuses, equipment, materials and other products used for medical purposes exclusively or in combination with each other as well as together with the other units necessary for the use of these products for their intended purpose including special software and products aimed by the manufacturer at the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring of the human body, medical research, recovery, replacement, anatomical organization or the organism’s physiological function changes, averting or termination of pregnancy, the functional purpose of which is not implemented by pharmacological, immunological, genetic or metabolic exposure on the human body, constitute medical products.
In accordance with order No.7n of the Ministry of Healthcare of the Russian Federation “On Import Authorization of Medical Products for the Purpose of Official Registration in the Territory of the Russian Federation” dated 15.06.2012 Roszdravnadzor licenses the medical products import for the official registration purposes.
As per State Standard GOST 31508-2012 “Medical Products. Classification according to the potential risk of application. General requirements" belonging to a medical product — items that are not medical products on their own and according to their intended use applied jointly with medical products or in their structure in order to use medical products with respect to the intended use.
Hence an import authorization is not required for the medical product accessories.