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.
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.
In accordance with Federal Law No.323–FZ “On Fundamental Healthcare Principles in the Russian Federation” dated 21.11.2011 (hereinafter referred to as Federal Law No.323–FZ 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.
Implementation of preventive medical examinations of the population is a medical activity and is subject to licensing according to Resolution No.291 of the Government of the Russian Federation dated 16.04.2012 “On Licensing of Medical Activities (with the exception of the specified activity performed by medical organizations and other organizations belonging to the private health care system in the territory of the innovation center of Skolkovo)”.
Special requirements for the organization of procedure of conducting a preventive medical examination include the availability of the material resources (the medical products located in rooms equipped for special purposes) and medical and other personnel of the corresponding qualification ensuring compliance with the established scope of medical examination of citizens according to Order No.1011n by the Ministry of Healthcare of the Russian Federation dated 06.12.2012 “On Approval of the Procedure for Conducting Preventive Medical Examination”.
In case the medical products that allow to perform medical examinations independently, are stationary located in a mobile complex, for example: X-ray examination, mammography, ultrasonic screening of abdominal cavity organs and small pelvis organs, electrocardiography, examination by a medical assistant (obstetrician), including taking a swab (scraping) from the surface of the neck of the uterus and the cervical canal for cytologic screening, clinical and biochemical blood assay, clinical common urine analysis and measurement of the ophthalmotonous pressure then such complex is a medical product and is subject to the official registration in accordance with the established procedure.
In case the mobile medical complex is used for displacement of portable medical products allowing to perform fully or partially the medical services on the basis of other medical units or other rooms included in the scope of preventive medical examination or in the scope of the first stage of medical examination and there are no stationary medical products (not portable), then such mobile complex is not a medical product and is no subject to the official registration as a medical product in the established order in the Russian Federation.
In accordance with sub-clause 17 of clause 1 of article 12 of Federal Law No. 99-FZ "On Licensing of Particular Types of Activity" dated 05/04/2011, manufacturing and technical maintenance of medical equipment are subject to licensing (except the case when technical maintenance is performed to meet the demands of a legal entity or an individual entrepreneur).
Regulation on licensing of manufacturing and manufacturing and technical maintenance of medical equipment (except the case when technical maintenance is performed to meet the demands of a legal entity or an individual entrepreneur) was approved by the Decree of the Government of the Russian Federation No. 469 dated 06/03/2013 (hereinafter referred to as the Regulation).
In accordance with the Regulation, the term "medical equipment" stands for medical products including tools, apparatuses, devices, equipment applied for medical purposes separately or together as well as with other appliances required for utilization of the above mentioned devices for their designated purpose including special software and designed by the manufacturer for preventive measures, diagnostics, cure and medical rehabilitation of diseases, monitoring of the human health, carrying out of medical research, restoration, substitution, changing of anatomic structure or physiological functions of human body, for prevention of pregnancy or abortions, functionality of which is not implemented by means of pharmacological, immunological, genetic, or metabolic intervention in the human body.
In case the manufactured devices can be categorized as medical equipment according to their technical specifications and comply with the term specified in the Regulation, the manufacturing and technical maintenance of such devices is subject to licensing.
If the marketing authorisation for the medical product is available, the applicant has a right to sale the registered device in the territory of the Russian Federation. The medical product should be sold under the same name as indicated in the marketing authorisation and in compliance with the information specified in the registration dossier.
In accordance with requirements of the Law of the Russian Federation No. 2300-1 "On Protection of Consumers' Rights" dated 02/07/1992, the seller should provide the purchaser with necessary and correct information about the product, its manufacturer and the organisation authorised by the manufacturer (seller).
The volume of mandatory information about the product to be provided to the consumer by means of marking, on labels, in technical documentation attached to the product or by other means is specified in article 10 of the said Law and in clauses 11, 12 and 72 of "Rules of Sales of Particular Types of Products" approved by the Decree of the Government of the Russian Federation No. 55 dated 01/19/1998 (hereinafter referred to as the Rules of Sales of Particular Types of Products).
Apart from information specified in clauses 11, 12 of the Rules of Sales of Particular Types of Products, the information of medical products should include the number and date of the permit for application of such devices for medical purposes issued by the Federal Service for Healthcare Supervision in accordance with the specified procedure and also with allowances made for distinctions of the particular product, information about its intended use, method and terms of application, action and effect and restrictions (counterindications) for its use.
In case of sales of a medical product with the name different from the one indicated in the marketing authorisation (with indication of a trademark), it's necessary to submit a package of documents for introduction of amendments in accordance with sub-clause "c" of clause 37 of the Rules of the State Registration of Medical products approved by the Decree of the Government of the Russian Federation No. 1416 "On Approval of the Rules of the State Registration of Medical products" dated 12/27/2012 (hereinafter referred to as the Rules) and to submit the documents confirming these amendments in accordance with clause 39 of the Rules as well as the documents confirming registration and utilization of the trademark by the applicant.
In case of sales of a medical product with the same name specified in the marketing authorisation with indication of the trademark on the package, the applicant informs RZN about introduction of amendments to the label (package) of the medical product in accordance with clause 55 of the Rules. To do this, it's necessary to submit an application on introduction of amendments and the documents confirming such amendments (including the documents confirming the right to use logos of other organisations in the label (package)) to the registering authority.
Also, the Informational Letters section of the official website of RZN contains the Rospatent letter on utilization of intellectual property No. 02/21-14928/08 dated 10/31/2014.
The best way to sent such report is the Notification of an Adverse Reaction (Event) Related to Application of a Medical product which is downloadable on the RZN official website. It should be noted that this form is designed to be completed by a person with medical education.
The patients revealed the adverse effects of a medical product have a right to request their doctor to fill in this notification and send it to RZN or forward the completed notification on their own. In accordance with Regulation on Establishment of the Federal Service for Health Care Supervision approved by the Decree of the Government of the Russian Federation No. 323 dated 06/30/2004 and the Order of Ministry of Healthcare of the Russian Federation No. 12n "On Approval of the Procedure of Notification of All Cases of Adverse Effects not Specified in Operation Manual of Medical product, of Adverse Reactions after its Application and Distinctions of Cooperation of Medical products, of Facts Posing Risk to Life and Health of Citizens and Medical Employees during Application and Operation of Medical products by the Subjects of Utilization of Medical products" dated 06/20/2012 (registered in the Ministry of Justice of Russia with No. 24962 dated 07/20/2012) and torder of the Ministry of Health of Russia No. 175n "On Approval of the Procedure of Safety Monitoring of Medical products" dated 09/14/2012 (registered in the Ministry of Justice of Russia with No. 24962 dated 09/14/2012), after receipt of such information and on the basis of the received messages describing facts and circumstances posing risk to life and health of citizens and medical employees during application and operation of medical products, RZN makes a decision on suspension of application of the medical product for a period not exceeding twenty business days and checks the submitted information in accordance with article 10 of the Federal Law "On Protection of Rights of Legal Entities and Individual Entrepreneurs during Crrying out of State Supervision and Municipal Supervision". After the check, RZN makes a decision to withdraw utilization of the medical product or to continue its application or utilization.
RZN has a right to deny substitution of the marketing authorisation in the following cases:
a) Incompliance of the information contained in the application for substitution with the information contained in the marketing authorisation being substituted;
b) Lack of information in the application required for substitution (for example: About the place of manufacturing of the medical product specified by the manufacturer, on type of the medical product in accordance with the Nomenclature classification of medical products according to their types approved by Order No. 4 of the Ministry of Healthcare of the Russian Federation dated 06/06/2012 and the letter of the Ministry of Healthcare of Russia No. 277/25-3 dated 03/13/2013 (Information letter of RZN No. 277/25-3 dated 04/01/2013);
c) Lack of the duly approved manufacturer's power of attorney for actions linked to substitution of the marketing authorisation.
