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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of December 27, 2012 No. 1416

About approval of Rules of state registration of medical products

(as amended on 24-11-2020)

According to article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" Government of the Russian Federation decides:

1. Approve the enclosed Rules of state registration of medical products.

2. Determine that:

a) registration certificates affect the products of medical appointment and medical equipment with fixed term of action issued about day of entry into force of this resolution before the expiration of the effective period specified in them;

b) registration certificates are valid for the products of medical appointment and medical equipment of termless action issued about day of entry into force of this resolution and are subject to replacement till January 1, 2017 by registration certificates in the form approved by the Federal Service on supervision in the field of health care.

Replacement of the registration certificate is performed without passing of the procedure of state registration of medical products based on the application submitted by the applicant in the Federal Service on supervision in the field of health care with indication of the data provided by the Rules approved by this resolution.

3. State registration of the medical products provided on state registration about day of entry into force of this resolution is performed based on the documents submitted about day of entry into force of this resolution, and also the application for state registration of the medical product submitted by the applicant according to the Rules approved by this resolution in the Federal Service on supervision in the field of health care.

4. Realization of the powers provided by this resolution is performed in the limits set by the Government of the limiting Russian Federation of number of employees of central office of the Federal Service on supervision in the field of health care, and also the budgetary appropriations provided to Service in the federal budget on management and management in the field of the established functions.

5. This resolution becomes effective since January 1, 2013.

Russian Prime Minister

D. Medvedev

 

Approved by the Order of the Government of the Russian Federation of December 27, 2012 No. 1416

Rules of state registration of medical products

1. These rules establish procedure for state registration of the medical products which are subject to the address in the territory of the Russian Federation.

2. Any tools, devices, devices, the equipment, materials and other products applied in the medical purposes separately or in combination among themselves and also together with other accessories necessary for application of the specified products to destination, including the special software, and (manufacturer) for prevention, diagnostics, treatment and medical rehabilitation of diseases, monitoring of condition of human body, carrying out medical researches, recovery, substitution, change of anatomical structure or physiological functions of organism, prevention or termination of pregnancy which functional purpose is not implemented by pharmacological, immunological, genetic or metabolic impact on human body (further - medical products) are subject to state registration.

The medical products listed in Item 11 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014 including medical products which are made by individual orders of patients to which special requirements to destination of health workers are imposed and which are intended only for personal use by the specific patient and also medical products which are held for use in the territory of the international medical cluster or in the territories of the innovative scientific and technology centers are not subject to state registration according to part 5 of article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation".

3. State registration of medical products is performed by the Federal Service on supervision in the field of health care (further - registering body).

4. In these rules the following basic concepts are used:

"safety of medical product" - lack of unacceptable risk of damnification of life, to health of the person and the environment when using medical product to destination in the conditions provided by the producer (manufacturer);

"quality of medical product" - set of the properties and characteristics of medical product influencing its capability to be effective to destination on condition of compliance to requirements of the regulating documentation, technical and operational documentation of the producer (manufacturer);

"clinical testing" - the developed and planned systematic research undertaken including with participation of the person as the subject for assessment of safety and efficiency of medical product;

"regulating documentation" - the documents regulating safety requirements, qualities, and also expected efficiency of the provided application and control methods of compliance of medical product to these requirements;

"the registration file" - set of the documents submitted for state registration, modification of such documents, and also copies of the decisions made by registering body on specific medical item;

"technical documentation of the producer (manufacturer)" - the documents regulating design of medical product, establishing technical requirements and containing data for its development, production, application, operation, maintenance, repair, utilization or destruction;

"technical testing (manufacturer)" - testing for the purpose of determination of compliance of characteristics (properties) of medical product to requirements of the regulating documentation, technical and operational documentation of the producer and adoption of the subsequent decision on possibility of carrying out clinical testing;

"toxicological researches" - researches for the purpose of assessment of biological safety of medical product and adoption of the subsequent decision on possibility of carrying out clinical testing;

"the authorized representative of the producer (manufacturer)" - the legal entity, or the individual entrepreneur registered in the territory of the Russian Federation, authorized by the producer (manufacturer) of medical product to represent its interests concerning the address of medical product in the territory of the Russian Federation, including concerning assessment procedures of compliance and state registration addressed to which the registration certificate on medical product can be issued;

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