To approve the enclosed Regulation on the Procedure of the State Registration of Medical Products
APPROVED
by Decree of the Government
of the Russian Federation
dated ________________ No ____
Regulation
on the Procedure of State Registration of Medical Products
1. The present Regulation shall determine the procedure of conducting of the state registration of medical products, executed in the name of the legal entity or individual entrepreneur, registered in compliance with the established procedure in the territory of the Russian Federation (hereinafter – the Regulation).
2. In the territory of the Russian Federation the use of the medical products registered in compliance with the established procedure shall be allowed.
3.All medical products, expected for medical application in the territory of the Russian Federation and including any tools, apparatuses, devices, equipment, materials and other products applied for medical purposes separately or in combination with each other as well as together with other accessories, essential for application of the specified goods for their intended purpose including customized software and designed by the manufacturer for prevention, diagnostics, treatment and medical rehabilitation of diseases, monitoring of the human body condition, conducting of medical investigations, restoration, replacement, change of anatomical structure or physiological functions of the body, prevention or interruption of pregnancy, functional purpose of which is not implemented by pharmacological, immunological, genetic or metabolic effect on the human body shall be subject for the state registration in compliance with nomenclature classification of the medical products, approved by the federal body of executive power authorized by it.
4. The classification of medical products depending on the potential risk of their application for medical purposes shall be approved by the authorized federal body of executive power.
5. The medical products which are customized for patients and to which special requirements concerning prescriptions by medical workers are presented and which are designed for personal use of a particular patient only shall not be subject for the state registration.
6. The state registration of medical products shall be carried out by the Federal Supervision Service for Healthcare and Social Development (Roszdravnadzor) (hereinafter – the registration body).
7. The term of validity of the marketing authorization is unlimited.
8. The state registration of medical products shall be executed on the basis of conformity assessment in the form of:
a) technical testing;
b) toxicological examination (concerning the medical products which use assumes contact with the human body);
c) clinical testing;
d) expert evaluation of quality, efficiency and safety of medical products;
e) testing for the purpose of approval of the metering device type (concerning medical products related to the metering devices in the sphere of в state regulation of measurement assurance in compliance with the approved list)
9. The procedure of conformity assessment of medical products for the purposes of the state registration of medical products shall be carried out by the institutions accredited in compliance with the procedure established by the legislation of the Russian Federation, having the license for medical activity execution in the sphere of the medical product’s application and it shall be executed in compliance with the procedure approved by the authorized federal body of executive power.
10. For the state registration of medical products the manufacturer (the authorized representative of the manufacturer) of the medical product or individuals and legal entities (hereinafter - the applicant) shall submit to the registration body the following documents:
1) application for the state registration of the medical product;
2) the document, supporting the payment of the state duty for the state registration of the medical product;
3) documents supporting registration as the legal entity or individual entrepreneur of the medical product’s manufacturer, the authorized representative of the manufacturer (if available);
4) documents supporting registration with the tax authority of the medical product’s manufacturer (in case the manufacturing is executed in the territory of the Russian Federation) and/ or the authorized representative;
5) documents supporting conformity of production conditions of the medical product under registration to the requirements of national and/ or international standards, guidelines, technical regulations, issued by the competent authority of the country-manufacturer of the medical product under registration and certified in compliance with the established procedure;
6) notarized copies of the agreement and/ or the power of attorney, supporting the authority of the manufacturer’s representative for every issue of design, technical characteristics, quality, efficiency, safety of the medical product as well as conformity assessment procedures related to them (in case when the registration of the medical product is executed in the name of the authorized representative of the manufacturer);
7) the copy of the document supporting permit for use of the medical product under registration (in case when manufacturing of the medical product is executed abroad);
8) the power of attorney, supporting authority of the applicant in terms of the state registration of the medical product (in case when the applicant is not the manufacturer of the medical product or the authorized representative of the manufacturer);
9) the draft of the regulatory document;
10) operational documentation for the medical product (including the draft of the manual on medical application of the medical product);
11) a photograph of the medical product (at least 18x24 cm in size) or advertising-illustrative materials with depiction of the medical product including accessories;
12) the document certifying the results of technical testing of the medical product (record sheets and/ or acts);
13) the document certifying the results of the toxicological examinations of the medical product (record sheets and/ or acts):
a) of the medical product, contacting with the surface of the human body;
b) of the medical product connected from the outside;
c) of the implanted medical product.
It is not allowed to require from the applicant to submit the documents not provided by the present Regulation.
12. Conducting the check of the data contained in the documents submitted by the applicant, the registration body shall inquire the data, essential for provision of the state service on registration of the medical product being at disposal of the bodies providing the state services, the bodies providing municipal services, other state bodies, local government bodies or institutions subordinate to the state bodies or local government bodies in compliance with the procedure established by Federal Law ‘Concerning Organization of the Provision of the State and Municipal Services’.
13. The state registration of medical products shall be executed by the registration body within a period not exceeding one hundred forty days from the date of acceptance of the application for the state registration of the medical product. Conducting of clinical testing of the medical product shall not be taken into account when calculating the period of its state registration.
14. The marketing authorization shall be issued in the blank sheet being strictly accountable documents and fraud resistant graphic product (every such blank sheet has series and number) in compliance with the form, approved by the authorized federal body of executive power.
The marketing authorization issued in the blank sheet of the registration body or in the form of the electronic document, signed with electronic digital signature is an official document confirming the fact of the state registration of the medical product.
The copy of the marketing authorization shall be subject for storage in the registration body issued it.
15. Keeping of the documents, presented for the state registration of the medical product, expert reports, second copy of the marketing authorization shall be executed by the registration body in compliance with the legislation of the Russian Federation.
16. The registration body shall place the information on the process of decision of the state registration taking by it in the Unified Portal for State and Municipal Services (Functions) in compliance with the procedure established by the Government of the Russian Federation.
17. The state duty in the amount and in compliance with procedure established by the legislation on taxies and levies of the Russian Federation shall be paid for the state registration of medical products, expert evaluation of quality, efficiency and safety of medical products and introduction of alterations into the registration documentation.
18. The state registration of the product can be denied in the following cases:
1) failure to submit or incomplete submission of the documents for the state registration of the medical product by the applicant;
2) non-conformity of the legal entity or individual entrepreneur in whose name the state registration of the medical products is being executed to the requirements stated in Clause 7 of the present Regulation;
3) provision of unreliable or invalid data on the medical product by the applicant;
4) inconsistency of the provided information in the documents of the set;
5) receipt of the expert report about insecurity, inefficiency or unproved quality, efficiency and safety of the medical product provided that it certifies:
a) that risk of application of the medical product is higher than the expected efficiency;
b) of insufficient evidence of the medical product efficiency;
в) of non-conformity of the data, stated in the documents provided for the state registration of the medical product to actual data.
19. The state registration of medical products different by their application properties under one name as well as multiple state registration of one and the same type of the medical product under one or different names shall be not allowed.
by Decree of the Government
of the Russian Federation
dated ________________ No ____
Regulation
on the Procedure of State Registration of Medical Products
1. The present Regulation shall determine the procedure of conducting of the state registration of medical products, executed in the name of the legal entity or individual entrepreneur, registered in compliance with the established procedure in the territory of the Russian Federation (hereinafter – the Regulation).
2. In the territory of the Russian Federation the use of the medical products registered in compliance with the established procedure shall be allowed.
3.All medical products, expected for medical application in the territory of the Russian Federation and including any tools, apparatuses, devices, equipment, materials and other products applied for medical purposes separately or in combination with each other as well as together with other accessories, essential for application of the specified goods for their intended purpose including customized software and designed by the manufacturer for prevention, diagnostics, treatment and medical rehabilitation of diseases, monitoring of the human body condition, conducting of medical investigations, restoration, replacement, change of anatomical structure or physiological functions of the body, prevention or interruption of pregnancy, functional purpose of which is not implemented by pharmacological, immunological, genetic or metabolic effect on the human body shall be subject for the state registration in compliance with nomenclature classification of the medical products, approved by the federal body of executive power authorized by it.
4. The classification of medical products depending on the potential risk of their application for medical purposes shall be approved by the authorized federal body of executive power.
5. The medical products which are customized for patients and to which special requirements concerning prescriptions by medical workers are presented and which are designed for personal use of a particular patient only shall not be subject for the state registration.
6. The state registration of medical products shall be carried out by the Federal Supervision Service for Healthcare and Social Development (Roszdravnadzor) (hereinafter – the registration body).
7. The term of validity of the marketing authorization is unlimited.
8. The state registration of medical products shall be executed on the basis of conformity assessment in the form of:
a) technical testing;
b) toxicological examination (concerning the medical products which use assumes contact with the human body);
c) clinical testing;
d) expert evaluation of quality, efficiency and safety of medical products;
e) testing for the purpose of approval of the metering device type (concerning medical products related to the metering devices in the sphere of в state regulation of measurement assurance in compliance with the approved list)
9. The procedure of conformity assessment of medical products for the purposes of the state registration of medical products shall be carried out by the institutions accredited in compliance with the procedure established by the legislation of the Russian Federation, having the license for medical activity execution in the sphere of the medical product’s application and it shall be executed in compliance with the procedure approved by the authorized federal body of executive power.
10. For the state registration of medical products the manufacturer (the authorized representative of the manufacturer) of the medical product or individuals and legal entities (hereinafter - the applicant) shall submit to the registration body the following documents:
1) application for the state registration of the medical product;
2) the document, supporting the payment of the state duty for the state registration of the medical product;
3) documents supporting registration as the legal entity or individual entrepreneur of the medical product’s manufacturer, the authorized representative of the manufacturer (if available);
4) documents supporting registration with the tax authority of the medical product’s manufacturer (in case the manufacturing is executed in the territory of the Russian Federation) and/ or the authorized representative;
5) documents supporting conformity of production conditions of the medical product under registration to the requirements of national and/ or international standards, guidelines, technical regulations, issued by the competent authority of the country-manufacturer of the medical product under registration and certified in compliance with the established procedure;
6) notarized copies of the agreement and/ or the power of attorney, supporting the authority of the manufacturer’s representative for every issue of design, technical characteristics, quality, efficiency, safety of the medical product as well as conformity assessment procedures related to them (in case when the registration of the medical product is executed in the name of the authorized representative of the manufacturer);
7) the copy of the document supporting permit for use of the medical product under registration (in case when manufacturing of the medical product is executed abroad);
8) the power of attorney, supporting authority of the applicant in terms of the state registration of the medical product (in case when the applicant is not the manufacturer of the medical product or the authorized representative of the manufacturer);
9) the draft of the regulatory document;
10) operational documentation for the medical product (including the draft of the manual on medical application of the medical product);
11) a photograph of the medical product (at least 18x24 cm in size) or advertising-illustrative materials with depiction of the medical product including accessories;
12) the document certifying the results of technical testing of the medical product (record sheets and/ or acts);
13) the document certifying the results of the toxicological examinations of the medical product (record sheets and/ or acts):
a) of the medical product, contacting with the surface of the human body;
b) of the medical product connected from the outside;
c) of the implanted medical product.
It is not allowed to require from the applicant to submit the documents not provided by the present Regulation.
12. Conducting the check of the data contained in the documents submitted by the applicant, the registration body shall inquire the data, essential for provision of the state service on registration of the medical product being at disposal of the bodies providing the state services, the bodies providing municipal services, other state bodies, local government bodies or institutions subordinate to the state bodies or local government bodies in compliance with the procedure established by Federal Law ‘Concerning Organization of the Provision of the State and Municipal Services’.
13. The state registration of medical products shall be executed by the registration body within a period not exceeding one hundred forty days from the date of acceptance of the application for the state registration of the medical product. Conducting of clinical testing of the medical product shall not be taken into account when calculating the period of its state registration.
14. The marketing authorization shall be issued in the blank sheet being strictly accountable documents and fraud resistant graphic product (every such blank sheet has series and number) in compliance with the form, approved by the authorized federal body of executive power.
The marketing authorization issued in the blank sheet of the registration body or in the form of the electronic document, signed with electronic digital signature is an official document confirming the fact of the state registration of the medical product.
The copy of the marketing authorization shall be subject for storage in the registration body issued it.
15. Keeping of the documents, presented for the state registration of the medical product, expert reports, second copy of the marketing authorization shall be executed by the registration body in compliance with the legislation of the Russian Federation.
16. The registration body shall place the information on the process of decision of the state registration taking by it in the Unified Portal for State and Municipal Services (Functions) in compliance with the procedure established by the Government of the Russian Federation.
17. The state duty in the amount and in compliance with procedure established by the legislation on taxies and levies of the Russian Federation shall be paid for the state registration of medical products, expert evaluation of quality, efficiency and safety of medical products and introduction of alterations into the registration documentation.
18. The state registration of the product can be denied in the following cases:
1) failure to submit or incomplete submission of the documents for the state registration of the medical product by the applicant;
2) non-conformity of the legal entity or individual entrepreneur in whose name the state registration of the medical products is being executed to the requirements stated in Clause 7 of the present Regulation;
3) provision of unreliable or invalid data on the medical product by the applicant;
4) inconsistency of the provided information in the documents of the set;
5) receipt of the expert report about insecurity, inefficiency or unproved quality, efficiency and safety of the medical product provided that it certifies:
a) that risk of application of the medical product is higher than the expected efficiency;
b) of insufficient evidence of the medical product efficiency;
в) of non-conformity of the data, stated in the documents provided for the state registration of the medical product to actual data.
19. The state registration of medical products different by their application properties under one name as well as multiple state registration of one and the same type of the medical product under one or different names shall be not allowed.
