Any medical device that is manufactured in Russia or abroad is subject to mandatory state registration in the Russian Federation. Registration is carried out by the Federal Service for Supervision in the Sphere of Healthcare on the basis of evaluation of documents of the registration dossier confirming the quality, efficiency and safety of medical devices. The rules of state registration of medical devices are outlined in the Decree of the Government of the Russian Federation dated December 27, 2012 N 1416.

The procedure for registering medical devices has many features and is a complex multistage process. Therefore, to successfully obtain a registration certificate in the best possible time it is necessary to attract specialists in this field. Our employees have a high level of competence and guarantee high quality of services.

Currently (until December 31, 2021) registration of medical devices can be carried out both under national rules, and under the new rules of the Eurasian Economic Union (EAEC).

How the procedure for registering a medical device is going:

1. Preliminary preparation of documentation. At the initial stage, we prepare an application for registration, review the documents provided by the client, assess their compliance with the legislation, adjust the documentation to meet the requirements of standards, if necessary, develop missing documentation, develop technical documentation, adjust the operational documentation.  In case of registration of a foreign-made product, we issue a permit to import samples for further testing.
2. Technical testing. For testing, we cooperate with approved laboratories that have the necessary accreditation and experience. We agree and check the test report, program and protocol to eliminate errors and discrepancies.
3. Initial examination of the file at Roszdravnadzor. As part of this stage, we form and submit the dossier to Roszdravnadzor, and finalize the documentation in the event of expert comments. Registration documentation is checked for completeness and reliability of the information provided (5 working days). We also examine the quality, efficiency and safety of the product (20 working days). As a result, we obtain permission to conduct clinical trials. For risk class 1 products and in vitro diagnostic products, initial examination and approval for clinical trials are not required.
4. Clinical and laboratory tests. This step is necessary to confirm the safety and effectiveness of the product and its compliance with the stated requirements. We conclude an agreement with a clinical laboratory, agree on a test program, obtain the results of clinical and laboratory tests, and check the test report and protocol.
5. Secondary examination of the dossier in Roszdravnadzor. At the second stage of the examination, we check the data of clinical trials. For class 1 risk products and in vitro diagnostic products, we conduct an examination of quality, efficiency and safety (10 working days). The decision is made to enter the product into the state register and issue a registration certificate to the applicant.

Thus, the service to support the state registration of medical devices includes:

1. Analysis of documentation
2. Development of the Application for state registration
3. Preparation of technical documentation
4. Finalisation of operational documentation
5. Preparation of information on regulatory documentation
6. Technical testing organization
7. Clinical and laboratory test design development
8. Organization of clinical and laboratory tests
9. Preparation of the package of documents and preparation of the registration dossier for submission to Roszdravnadzor
10. Obtaining the registration certificate of Roszdravnadzor.

Including, for products of foreign production the following services are additionally provided:

11. Translation of documentation for a medical device (to be issued separately)
12. Approval for import of samples

Dates and cost of medical devices registration

The procedure of registering medical devices takes a long time, from 8 to 13 months. The time required for registration depends on the complexity of the device, its risk class, completeness and quality of information about the device, the promptness with which the manufacturer provides the requested data about the device. According to Resolution No. 1416, regulated terms of examination in Roszdravnadzor are from 3 to 6-7 months, depending on the risk class of the device.

To determine the terms and final cost, we need to obtain information about the registered product (name, purpose, principle of operation, type of documentation to be developed).

Besides, separately from the registration of a medical device, such services as translation of documentation, notarization of necessary documents, state duty are paid (for issuance of registration certificate – 7000 roubles; for examination of quality, efficiency and safety of medical device – from 45000 to 115000 depending on the risk class of medical device).

Risk classes of medical devices

According to the Order of the Ministry of Health of June 6, 2012 N 4n medical devices are divided into four classes depending on the potential risk of use:

• class 1 – medical devices with low individual risk and low public health risk;
• class 2a – medical devices with moderate individual risk and/or low public health risk;
• class 2b – medical devices with a high individual risk and/or moderate public health risk;
• class 3 – medical devices with high individual risk and/or high public health risk.

Amount of the state fee

In accordance with the class, the amount of state duty is determined for examination of quality, efficiency and safety of medical devices.

• class 1 – 45,000 roubles;
• class 2a – 65,000 roubles;
• class 2b – 85,000 roubles;
• class 3 – 115,000 roubles;

“Tax Code of the Russian Federation (Part Two)” of 05.08.2000 N 117-FZ (edition of 15.10.2020)

Our company offers services on registration of medical devices under the rules of the Eurasian Economic Union (EAEC). Russia, along with the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, the Kyrgyz Republic is part of the EAEC. The purpose of the union was to simplify the rules of economic interaction between countries, resulting in the establishment of common standards of safety and quality for different categories of products. This condition applies to medical devices and their registration. The general order of cooperation between the countries in this segment is established by the provisions of the EAEC Treaty of May 29, 2014. Rules for registration and examination of safety, quality and efficiency of medical devices are regulated by the EEEC Council Decision No. 46 of 2016.

At present, before (December 31, 2021) registration of medical devices can be carried out both under national rules and under new rules of the Eurasian Economic Union. After December 31, 2021 all registration certificates will be issued only under the EAEC procedure. Registration certificates of the new type are issued indefinitely and open access to the markets of other countries that are members of the Union, and allow to operate within the integrated information system of the unified market of medical devices EAEC. The registration procedure under the new rules is more complex and places strict requirements on the medical device and related documentation. Registration under the new rules may take from 1 to 2 years, but the registration certificate issued under the new rules may become a big advantage over competitors on the medical devices market.

Our employees are experts in the field of registration of medical devices, have extensive experience of cooperation with Roszdravnadzor and work experience according to EAES standards.

How is the registration of medical devices under the rules of the EAEC:

Stage 1 – preparation of registration dossier documents

• Determination of the risk class of the product: according to the Decision of the Eurasian Economic Commission dated December 22, 2015 № 173, medical devices are divided into 4 classes, depending on the potential risk of application. The necessary composition of the registration dossier documents depends on whether the product belongs to a particular risk class.
• Determining the list of necessary documents of the registration dossier (depends on the type of product in vitro / not in vitro, risk class of the product).
• Evidence of product safety and efficiency. The general requirements for safety, efficiency, marking and operational documentation are regulated by the Decision of the EAEC Council No. 27 of February 12, 2016. At this stage, all necessary types of tests (technical, clinical and laboratory, tests performed to assess the biological impact of a medical device) are conducted. The scope, timing and cost of tests are determined by the specifics of the product and are carried out in the tested laboratories that have the appropriate accreditation and experience.
• Collection and submission of registration dossier to Roszdravnadzor

Stage 2 – medical device registration and examination

• Verification by Roszdravnadzor of the completeness and reliability of submitted documents (application for expert examination and registration, registration dossier, copies of documents on payment for expert examination and registration).
• Inspection of production and technological process for the production of medical devices
• Conducting an expert examination of a medical device and drawing up an expert opinion
• Approval of the expert opinion. The Expert Opinion shall be published in a special information network to which all member countries of the Union have access. After the states have analysed the expert opinion, a verdict on the possibility of registration is issued.
• Registration certificate execution.

For more details on the procedures of examination and registration of a medical device, regulatory documents, as well as the list of documents required for registration of a medical device, please visit the official portal of the EAEC: https://portal.eaeunion.org/_layouts/15/cit.eec.impop/portal.landings/medicaldevices.aspx.

Regulatory documentation in the field of registration of medical devices according to EAEC rules

Acts in the field of circulation of medical devices

Agreement on common principles and rules of circulation of medical devices (medical devices and medical equipment) in the framework of the Eurasian Economic Union

Protocol on Accession of the Republic of Armenia to the Agreement on Common Principles and Rules for Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014

Decisions of the Council of the Eurasian Economic Commission

Decision of the Council of the Eurasian Economic Commission on February 12, 2016 № 46 “On the rules of registration and examination of safety, quality and efficiency of medical devices”.

Decision of the Council of the Eurasian Economic Commission on February 12, 2016 № 26 “On the special sign of circulation of medical devices”.

Decision of the Council of the Eurasian Economic Commission on February 12, 2016 № 27 “On approval of the General requirements for safety and efficiency of medical devices, requirements for their labelling and operational documentation on them”.

Decision of the Council of the Eurasian Economic Commission on February 12, 2016 № 28 “On approval of the Rules for technical testing of medical devices”.

Decision of the Council of the Eurasian Economic Commission on February 12, 2016 № 29 “On the rules of clinical and clinical laboratory tests (researches) of medical devices”.

Decision of the Council of the Eurasian Economic Commission on February 12, 2016 № 30 “On approval of the formation and maintenance of an information system in the circulation of medical devices”.

Decision of the Council of the Eurasian Economic Commission on February 12, 2016 № 42 “On approval of the list of types of medical devices to be referred to the measuring instruments during their registration”.

Decision of the Council of the Eurasian Economic Commission on May 16, 2016 № 38 “On approval of the Rules of research (tests) to assess the biological effects of medical devices”.

Decision of the Council of the Eurasian Economic Commission on December 21, 2016 № 141 “On approval of the Order of application by authorized bodies of the Eurasian Economic Union member states of measures on suspension or prohibition of use of medical devices that are dangerous for life and/or health of people, malignant, counterfeit or falsified medical devices and their withdrawal from circulation on the territories of the Eurasian Economic Union member states”.

Decision of the Council of the Eurasian Economic Commission from 10.11.2017 ¹ 106 “On approval of the Requirements for implementation, maintenance and evaluation of the quality management system of medical devices depending on the potential risk of their use”.

Decisions of the Board of the Eurasian Economic Commission

Decision of the Board of the Eurasian Economic Commission dated December 22, 2015
No. 173 “On approval of the Rules for Classification of Medical Devices according to Potential Application Risk”.

Decision of the Board of the Eurasian Economic Commission dated December 22, 2015
No. 174 “On approval of the Rules for monitoring the safety, quality and efficiency of medical devices”.

Decision of the Collegium of the Eurasian Economic Commission of December 29, 2015
No. 177 “On the Rules of Nomenclature of Medical Devices”.
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Decision of the Board of the Eurasian Economic Commission on September 26, 2017 № 123 “On the Regulations on the advisory committee for medical devices”.

Decision of the Collegium of the Eurasian Economic Commission of July 24, 2018 № 116 “On the criteria for delineating the elements of a medical device that are components of a medical device for its registration”.

Decision of the Collegium of the Eurasian Economic Commission No. 123 of July 24, 2018 “On the Criteria for Inclusion in one registration certificate of several modifications of a medical device related to one type of medical device in accordance with the nomenclature of medical devices applied in the Eurasian Economic Union”.​​

Orders of the Collegium of the Eurasian Economic Commission

Order of the Board of the Eurasian Economic Commission on November 12, 2018 № 176 “On the introduction of a common process” Formation, maintenance and use of a single register of authorized organizations of the Eurasian Economic Union, carrying out research (testing) of medical devices for their registration”.

Order of the Board of the Eurasian Economic Commission on November 12, 2018 № 177 “On the introduction of a common process” Formation, maintenance and use of a unified information database for monitoring the safety, quality and efficiency of medical devices.

Recommendations of the Board of the Eurasian Economic Commission

Recommendation of the Board of the Eurasian Economic Commission of September 4, 2017 № 16 “On the Procedure for establishing a list of standards, resulting from the application of which on a voluntary basis, fully or partially ensure compliance of medical devices with General requirements for safety and efficiency of medical devices, requirements for their labelling and operational documentation on them”.

Recommendation of the Board of the Eurasian Economic Commission of September 4, 2017 № 17 “On the list of standards resulting from the application of which on a voluntary basis, fully or partially ensure compliance of medical devices with the General requirements for safety and efficiency of medical devices, requirements for their labelling and operational documentation on them”.​

Recommendation of the Board of the Eurasian Economic Commission of November 12, 2018 № 25 “On the criteria for attributing products to medical devices in the Eurasian Economic Union”.​

Recommendation of the EEC Collegium of May 21, 2019 № 14 “On Methodological Recommendations for the examination of safety, quality and efficiency of medical devices for their registration in the framework of the Eurasian Economic Union”.​​

​Recommendation of the Collegium of the Eurasian Economic Commission on October 8, 2019 № 29 “On Methodological recommendations on the content and structure of documents of the registration dossier of a medical device”.

We will help you promptly make changes to the registration certificate/file issued by Roszdravnadzor.

Grounds for making changes to the registration certificate for medical devices:

According to paragraph 37 of the Russian government decree of 27.12.2012 N 1416.

The changes made to the documents contained in the registration dossier, which do not require expert examination of the quality, efficiency and safety of medical devices, include:

a) change of information about the applicant, including information:

• on reorganization of a legal entity;
• on changing the name of the legal entity (full and (if any) abbreviated, including the firm name), address of its location;
• on change of surname, name and (if any) patronymic name, address of residence of the individual entrepreneur and details of his identity document;

b) change of information on the person in whose name the registration certificate for the medical device may be issued, including information:

• about reorganization of the legal person;
• on changing the name of the legal entity (full and (if any) abbreviated name, including the firm name), address of its location or surname, name and (if any) patronymic, place of residence of individual entrepreneur;

c) change of the address of the place of production (manufacturing) of the medical device;

d) change of the name of the medical device if the properties and characteristics affecting the quality, efficiency and safety of the medical device have not been changed or its properties and characteristics are improved with the invariability of its functional purpose and (or) the principle of operation that provides:

• adding (deleting) medical device accessories or changing their name;
• specifying, changing and excluding the trademark and other means of individualization of a medical device;
• change in the number of units of a medical device or its component parts, the components specified in the attachment to the registration certificate;
• indication or exclusion of variants of execution (models) of the medical device;
• change of marking and (or) packing of the medical device;

e) change of validity terms of documents contained in the registration dossier by the manufacturer (manufacturer) of the medical device;

f) change of information about the authorized representative of the manufacturer (manufacturer) of the medical device.

Risk Management File (FRM)

Operation Manual

Instructions for use

Label

Other documents