State registration of medical products

An application for state registration should contain the following:

a) name of the medical product (including accessories required for proper use of the medical product);

b) regarding the designer: full and (if applicable) shortened name, including trade name; form of incorporation and address (location) of the legal entity, its telephone numbers and e-mail (if applicable);

c) regarding the manufacturer (producer) of the medical product: full and (if applicable) shortened name, including trade name; form of incorporation; address (location) of the legal entity or the full name of the individual entrepreneur, their ID details, place of residence, as well as the telephone numbers and e-mail (if applicable) of the legal entity or individual entrepreneur;

d) regarding the authorized representative of the manufacturer (producer): full and (if applicable) shortened name, including trade name; form of incorporation and address (location) of the legal entity, its telephone numbers and e-mail (if applicable);

e) regarding the legal entity in whose name the registration certificate may be issued: full and (if applicable) shortened name, including trade name; form of incorporation and address (location) of the legal entity, its telephone numbers and e-mail (if applicable);

f) place where the medical product was manufactured;

g) purpose of the medical item as specified by the manufacturer (producer);

h) medical product type in accordance with the nomenclature classification of medical products;

i) medical product potential hazard class in accordance with the nomenclature classification of medical products;

j) All-Russian Classifier of Products code for the medical product;

k) information regarding the way of obtaining the registration certificate, as well as information related to the state registration procedure for the medical product.

The set of documents for state registration includes the following:

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

b) data on specifications for the medical product;

c) technical manual issued by the manufacturer (producer) for the medical product;

d) operational documents issued by the manufacturer (producer) for the medical product, including the application sheet and the user’s manual for the product;

e) photographic images of the general view of the medical product together with all its accessories necessary for its proper use (photograph not smaller than 18×24 cm in size);

f) documents confirming the results of the medical product technical tests;

g) documents confirming the results of toxicity tests of the medical product intended for patient contact;

h) documents confirming the results of pattern evaluation of measuring instruments (applicable to medical products classified as measuring instruments by the state regulator for the purpose of standardization of measures; the list of such products is adopted by the Russian Ministry of Healthcare);

i) inventory of the documents submitted;

j) data that confirms the clinical efficacy and safety of the medical

k) medical products draft tests plan with supporting materials (if any).

In case the documents specified in paragraph 10 of the Rules are drawn in a foreign language, they must be submitted accompanied by a duly certified translation into Russian.

The term and the sequence of the administrative procedures and actions of Roszdravnadzor are determined by the Administrative Regulation for Providing the Medical Products State Registration Service of the Russian Federal Service for Surveillance in Healthcare adopted by the Order of the Russian Ministry of Healthcare No. 737n dated 14 October, 2013.

The medical products state registration should be completed by Roszdravnadzor in no more than 50 working days from the date of the decision to start the state registration process for a medical product (medical products).

The 50-working day period does not include the time for clinical trials of the medical product.

Quality, efficiency and safety tests for the medical product should be performed by the expert body step-by-step in accordance with the procedure adopted by the Russian Ministry of Healthcare:

a) at Stage I, the application for state registration and the supporting documents listed in paragraph 10 of the Rules are examined with the aim of establishing whether it is possible (or not possible) to proceed to clinical trials of the medical product;

b) at Stage II the examination of the completeness and the results of the technical tests, toxicity tests and clinical trials performed is done, as well as of the pattern evaluation of measuring instruments (applicable to medical products classified as measuring instruments by the state regulator for the purpose of standardization of measures; the list of such products is adopted by the Russian Ministry of Healthcare) (hereinafter — the expert examination of the completeness and the results of the tests and trials).

At present, in the course of the quality, efficiency and safety tests of medical products for the purpose of state registration, the applicant may at any stage be required to provide missing documents and information (including be given a possibility to eliminate the faults and errors discovered by the expert examination).

Following Stage 1 of the expert examination, it is determined whether clinical trials of the medical product can be carried out or whether the state registration is not possible (for 1 class potential hazard medical products (except medical products classified as measuring tools by the state regulator for the purpose of standardization of measures; the list of such products is adopted by the Russian Ministry of Healthcare).

Clinical trials of the medical product should not be carried out unless a permit for clinical trials has been granted by Roszdravnadzor.

Clinical trials of a medical product should be carried out by a medical organisation among those included in the Register of Medical Organizations Authorized to Carry Out Clinical Trials of Medical Products. The Register is controlled by Roszdravnadzor.

Upon the completion of medical product clinical trials, the applicant should submit to Roszdravnadzor a request to resume the state registration of the medical product, accompanied with the results of the clinical trials.

At Stage II of the quality, efficiency and safety test, the expert body should proceed to an examination of the completeness and the results of the trials and tests performed, as well as draw and forward to the registering body an opinion regarding the results of the quality, efficiency and safety test of the medical product.

The applicant may be refused the state registration of the medical product if the opinion received by the registration body from the expert body following the results of the medical product quality, efficiency and safety test, states that the quality and/or efficiency and/or safety of the medical product to be registered have not been confirmed by the tests and/or that the risk of harming the health of the public and medical staff following the medical product use would surpass the its efficiency.

Within one working day upon making a decision with regards to the state registration of the medical product, Roszdravnadzor should introduce the information on the registered medical product to the State Register of Medical Products and Organisations (Individual Entrepreneurs) Authorized to Manufacture and Produce Medical Products.

In accordance with the Tax Code of the Russian Federation, the state duty for the quality, efficiency and safety tests of medical products is as follows:

class 1 — RUB 45,000;

class 2a — RUB 65,000;

class 2b — RUB 85,000;

class 3 — RUB 115,000.

The state fee for the state registration of a medical product amounts to RUB 7,000.