Home
Registration of medical devices

Registration of medical devices

Registration and circulation of medical devices

in the Russian Federation and the EAEU (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia)

Prior to placing medical devices on the market of the Russian Federation and/or the EAEU countries (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia), their quality, efficacy and safety must be confirmed through getting of registration license in these countries.

Foreign manufacturers need to take into account the specific requirements pertaining to the registration of medical devices in Russia and the EAEU countries.

The registration of medical devices is overseen by the Federal Service for Surveillance of Healthcare (Roszdravnadzor) in Russia and by the national centers for expert evaluation under the Ministry of Health in the EAEU countries.

We provide services for registration of all types of medical devices and in vitro diagnostic medical devices.

Specifics of registration of medical devices in Russia and the EAEU:

Registration of medical devices is mandatory for all medical devices.

All medical devices intended for use in the Russian Federation and/or the EAEU (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia) are subject to marketing authorization through the established procedure.

Depending on the risk to the patient, medical devices are divided into classes I, IIa, IIb and III.

The higher the risk class, the more complex the requirements for registration of a medical device, the more voluminous the application dossier and the more extensive the list of tests.

The time needed for obtaining a registration dossier of medical devices may vary.

The procedural timelines depend on the risk class and the complexity of registration procedure. Typically, the registration process takes 6 to 12 months.

Specific documentation and labeling requirements.

For registration and circulation of medical devices, technical and operational documentation must be provided in accordance with the local requirements of Russia and/or the EAEU, in Russian and/or the languages of the EAEU member states. It is also necessary to apply special labeling in Russian and/or the languages of the EAEU member countries.

Requirement to conduct local testing.

Local technical, toxicological, and clinical studies of medical devices are mandatory for registration. Manufacturer’s reports issued by international accredited laboratories are taken into account, but not accepted without local studies.

Regular variations.

Practically any change in the medical device (including, but not limited to: changes in technical, clinical or analytical characteristics; changes in intended use, indications and/or contraindications; changes in technical, operational documentation; changes in labeling, packaging, etc.) requires the MA variation procedure and should be confirmed by test protocols in local testing laboratories.

Manufacturing inspection for ISO 13485 compliance.

In accordance with the regulatory requirements of both Russia and the EAEU, inspection is necessary in order to confirm the compliance of the manufacturer's QMS with ISO 13485. Exception are class I medical devices and non-sterile class IIa devices.

Documentation in Russian and/or state languages of the EAEU member states.

All documentation submitted for registration and inspection of production must be provided with a translation into Russian.
When registration procedure is under the rules of the EAEU, operational documentation is also provided with translation into the state languages of the EAEU member countries (Armenian, Belarusian, Kazakh, Kyrgyz).

What services do we offer?

Expert consultation on the circulation of medical devices in the markets of the Russian Federation and the EAEU countries (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia).

We will provide simple and accessible information about the regulatory requirements and specifics at all stages of the life cycle of a medical device. Your personal manager will be in touch with you at any time convenient for you.

Preparation and development of documents for registration procedure of medical devices in the Russian Federation and/or the EAEU (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia).

Our specialists will prepare a set of documents for you in English and Russian.

Coordination of registration process, continuous support and communication with you at all stages of the marketing authorization process.

Our team will ensure interaction and organize work with all executive authorities, supervisory authorities, testing laboratories, expert organizations and other contractors and suppliers involved in the process of marketing authorization of medical devices. Your account manager will regularly inform you about the status of the project.

Organization of technical and EMC testing, clinical trials, toxicological studies, and clinical laboratory testing for in vitro diagnostic medical devices, testing of medical devices for approval of the type of measuring instruments.

We will select a suitable testing laboratory for testing, prepare the testing program and coordinate its approval, determine the number of samples of medical devices and requirements for them, draw up the necessary documents for importing samples, provide assistance in transporting the samples to the testing laboratory.

The possibility of storing your products in our warehouse.

If necessary, you can use the short-term or long-term storage for your products in our warehouse. We have all the necessary conditions for the proper and safe storage of medical devices, including refrigerators (2–8 ^о С) and freezers (from -5 to -18 ^о С).

Preparation of manufacturers (and manufacturing sites) for inspection (audit) by the Russian and EAEU regulatory authorities as part of the medical device registration process.

In accordance with the regulatory requirements of Russia and the EAEU countries, manufacturing inspection (audit) by regulatory authorities is required for some medical devices during registration process.

Post-marketing support and regulatory support of your products after the launch on the Russian and/or EAEU market. Possibility of subscription for post-marketing support.

Interaction with the Russian and EAEU regulatory authorities does not end after receiving the registration certificate. Throughout the life cycle of a medical device, the manufacturer must provide reports and information about the supplied medical devices, immediately inform about adverse events and corrective actions, and introduce variations to the registration dossier documents.

If you are a foreign manufacturer of medical devices and do not have a representative office in the Russian Federation, our company is ready to become your authorized representative in the Russian Federation.

In accordance with the requirements of Russian legislation, any foreign manufacturer of medical devices must operate in the Russian Federation through an authorized representative. An authorized representative of the manufacturer is a company representative office or another legal entity (or individual entrepreneur) authorized in the Russian Federation. We are ready to offer you tailor-made services as your authorized representative.

Budget planning for your project on introducing products.

We will help you in developing a comprehensive cost plan that takes into account hidden and commonly overlooked expenses. This includes evaluating the costs associated with post-authorization regulatory measures for the medical device.

A wide range of supplementary services tailored to meet your specific requirements.

Translation of documents, notarization, archival storage of documents, representation of your interests before any level of authority, document delivery services, etc.

Risk classes of medical devices

All medical devices are divided into 4 classes based on potential risk:

Class 1

Medical devices with low risk

Class 2a

Medical devices with medium risk

Class 2b

Medical devices with medium to high risk

Class 3

Medical devices with high risk

A registration certificate is granted for an unlimited period; however, it is applicable solely to the authorized version (generation, modification) of the medical device. Any modifications to the device or updates to its documentation must be promptly reflected by introduction of changes into the registration dossier.

Registration of in vitro diagnostic medical devices

The main differences are related to the specifics of in vitro diagnostic medical devices.

Development and preparation of technical and operational documentation in Russian (and other languages of EAEU member states for marketing authorization under the Union regulations).

Conducting local technical testing and clinical studies> (in Russia) or clinical laboratory studies

Technical testing of in vitro diagnostic medical devices

Technical testing is based on the following:

Analysis of data from scientific and technical literature related to the safety, efficiency, functionality of this device, as well as its application described in the regulatory, technical and operational documentation of the manufacturer.

Analysis of the trial results.

Clinical (clinical-laboratory) trials of in vitro diagnostic medical devices

Clinical trials of in vitro diagnostic medical devices are carried out in a laboratory setting and involve the analysis of biosamples obtained from patients during their diagnosis and treatment. Therefore, they are called clinical laboratory trials. The objective of these trials is to provide evidence of the effectiveness of the medical device and demonstrate that its functional characteristics enable the analysis of the target analyte.

Clinical trials confirm that there is a causal relationship between the analyte of interest and the suspected condition. They also validate the usefulness of this test in the diagnosis and selection of treatment strategy.

A registration certificate for an in vitro diagnostic medical device is granted for an unlimited period; however, it is applicable solely to the authorized generation (version, modification for analyzers) of the medical device. Any modifications to the in vitro diagnostic medical device or updates to its accompanying documentation must be promptly reflected by incorporating appropriate changes into the registration dossier.

Why us?

If you are looking for a reliable partner for registration of medical devices, we can offer you high-quality services, flexible individual approach to address your specific tasks, considering all your needs. Furthermore, we ensure swift implementation to meet your timelines.

Our specialists have extensive experience in marketing authorization of medical devices from top global manufacturers.

Our specialists will review your request and answer you within 24 hours

Our managers will arrange for you a detailed presentation about the process and features registration under the national rules of Russia and / or the EAEU, will tell you about the timing of each stage and how these time periods can be reduced? Together with you, we will determine the best registration plan for your products.