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;

- Invasiveness;

- Sterility;

- 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.

The import for the purpose of the official registration in accordance with order No.7n of the Ministry of Health 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 is not required for the medical products registered in accordance with the established procedure in the territory of the Russian Federation.

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.