Counter of appeals of citizens and organizations

State registration of medical devices

Application for state registration should contain the following information:

a) name of a medical device (with indication of accessories necessary for its intended use);

b) with respect to a developer: full and (if any) abbreviated name, including its company name, type of incorporation of a legal entity, address (location), as well as telephones, and (if any) e-mail of a legal entity;

c)  with respect to a manufacturer (producer) of a medical device: full and (if any) abbreviated name, including its company name, type of incorporation of a legal entity, location address or surname, first  name and (if any) patronymic name, details of a document  proving identity, residential address of an individual entrepreneur as well as telephones and (if any) e-mail of a legal entity or individual entrepreneur;

d) with respect to a manufacturer’s (producer’s) authorized representative: full and (if any) abbreviated name, including its company name, type of incorporation of a legal entity, address (location), as well as telephones and (if any) e-mail of a legal entity;

e) with respect to a legal entity in whose name the registration certificate may be issued: full and (if any) abbreviated name, including its company name, type of incorporation of a legal entity, address (location), as well as telephones and (if any) e-mail of a legal entity;

f) location of manufacturing of a medical device;

g) medical device intended use as established by a manufacturer (producer);

h) type of a medical device in accordance with the nomenclature classification of medical devices;

i) class of potential risk of medical device in accordance with the nomenclature classification of medical devices;

j) code according to the Russian National Classification;

k) Information about the method of obtaining of the registration certificate, as well as information on the procedure of state registration of a medical device.

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The following documents should be submitted for obtaining state registration of a medical device:

a) copy of a document confirming powers of manufacturer’s (producer’s) authorized representative;

b) information about regulatory documentation for a medical device;

c) manufacturer’s (producer’s) technical documentation for a medical device;

d) manufacturer’s (producer’s) operating documentation for a medical device, including package inserts or user manuals;

e) photographic images of a medical device together with all accessories necessary for intended use thereof (min. size 18 x 24 cm);

f) documents confirming the results of technical trials of the medical device;

g) documents confirming the results of toxicological studies of the medical device, which use includes human body contact;

h) documents confirming results of trials of a medical device for the purpose of approval of the type of measuring tools (with  respect to medical devices referred to measuring tools in the field of government regulation of the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);

i) list of documents submitted;

j) evidences of clinical effectiveness and safety of medical devices (if available);

k) draft plan of clinical trials of a medical device with any supporting materials (if available).

In a case when documents stated in paragraph 10 of the Rules are in a foreign language, they shall be submitted with a duly notarized translation into Russian.

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Timeframe and order of administrative procedures and administrative actions performed by Roszdravnadzor are regulated by the Administrative Regulation of the Federal Service on surveillance in Healthcare in Terms of Provision of the State Service of State Registration of Medical Devices approved by the Order of the Ministry of Health of the Russian Federation dated 14.10.2013 № 737n.

Roszdravnadzor shall perform state registration of medical devices within 50 working days following the date the decision to start state registration of medical devices has been made.

The duration of clinical trials of medical devices is not included into this 50 day’ period.

An expert institution shall provide expert evaluation of quality, efficacy and safety of a medical device in two stages in accordance with the procedure established by the Ministry of Health of the Russian Federation:

1) during  Stage I an application for registration and documents listed in paragraph 10 of the Rules are examined in order to determine the possibility (impossibility) of conducting clinical trials of a medical device;

2) during the Stage II expert evaluation of comprehensiveness and results of conducted technical, toxicological, clinical trials as well as the trails intended to approve the type of measuring tools (with respect to medical devices referred to measuring tools in the field of state regulation of the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation) (hereinafter referred to as the expertise of comprehensiveness and results of trials and studies) is performed.

There is a new feature that allows an applicant to present any missing materials and information (including possibility to eliminate any insufficiencies revealed during the expertise) during any stage of the expert evaluation of quality, efficacy and safety of medical devices for the purposes of the state registration.

Upon completion of Stage I experts determine possibility/impossibility of conducting clinical trials of medical devices or impossibility of state registration of a medical device (for the devices referred to the 1st class of potential risk of medical devices (except for medical devices referred to measuring tools in the field of government regulation of the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation).

Clinical trials require a permission to conduct clinical trials, issued by Roszdravnadzor.

Clinical trials of a medical device are held in medical institutions included into the List of Medical Institutions for Clinical Trials, approved by Roszdravnadzor.

Upon completion of  Clinical trials an applicant submits an application  to resume state registration of the medical device and the results of medical device clinical trials  to Roszdravnadzor

During Stage II of the expert evaluation of quality, efficacy and safety of a medical device an expert institution carries out the examination of completeness and results of the conducted trials and studies and sends the assessment  based on the results of the evaluation of quality, efficacy and safety of a medical device to the registration authorities

In case the assesment received from an expert institution on the results of the expert evaluation of quality, efficacy and safety of a medical device states  that quality and (or) efficacy and (or) safety of a medical device subject to the state registration haven’t been confirmed by the data obtained and (or) that the risk of damage to health of individuals and medical workers due to medical device administration exceeds the efficacy of its use, it becomes the base for decision to refuse the state registration of a medical device

Within 1 working day following the date a decision on the state registration of a medical device have been made, Roszdravnadzor enters data on the registered medical device into the State Registry of Medical Devices and Institutions (individual entrepreneurs) manufacturing and producting medical devices.

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In accordance with the Tax Code of the Russian Federation the state duty for conducting the expert examination of quality, efficacy and safety of medical devices is:

Class I – 45 000 rubles;

Class II a – 65 000 rubles;

Class II b – 85 000 rubles;

Class III – 115 000 rubles.

State duty for the registration of a medical device is 7 000 rubles.

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