Registration of medical devices according to the Russian Federation rules

Registration of medical devices is a complex multi-stage process that requires specific knowledge and, more importantly, relevant experience. That is why when you register a medical device with the help of KC-PROF experts you are guaranteed to receive a registration certificate in the shortest time possible. This result comes from the coordinated work of highly qualified experts with many years of experience in the field of medical device circulation. Our department of medical device registration consists of 9 experts, including 2 candidates of technical and 1 candidate of biological sciences.

What is registration and why is it necessary to register medical devices?

Following paragraph 4 of Article 38 of the Federal Law N 323-FZ “On the Basics of Protecting the Health of Citizens in the Russian Federation” dated November 21, 2011, the circulation of medical devices is allowed on the territory of the Russian Federation only if they were registered in the procedure established by the Government of the Russian Federation, by its authorized federal executive body.

Registration of medical devices is a state procedure developed to bring to the market only those products which are effective, safe and have high quality. The registration certificate (RC) is a document which confirms the compliance of medical devices with the established requirements and the fact of their registration in Russia. Therefore, RC is a document mandatory for the circulation of a medical device on the Russian market. In other words, the registration of medical devices is a prerequisite for their import, use, sale, as well as production on the territory of the Russian Federation.

Registration of medical devices on the territory of the Russian Federation is conducted by the Federal Service for Supervision of Healthcare of the Russian Federation (Roszdravnadzor). In the process of state registration, Roszdravnadzor sends the registration dossier of a medical device to one of the subordinate organizations, FSBI VNIIIMT or FSBI NIK (formerly called FSBI CMIKEE), for quality, safety and effectiveness examination.

Medical devices registration chart

The regulations for state registration of medical devices are determined by the Decree of the Government of the Russian Federation No. 1416 “On Approval of the Rules for State Registration of Medical Devices” dated December 27, 2012. These rules are reviewed periodically, which creates additional problems for all market participants since it is quite difficult for manufacturers and distributors of medical devices to keep track of these changes. The latest changes to the registration procedure have been made by the Decree of the Government of the Russian Federation No. 633 “On Amending the Rules for State Registration of Medical Devices” dated May 31, 2018. Certain changes to the procedure cause changes in the documents which regulate the activities of Roszdravnadzor and its expert organizations. Thus, most recently, there have been published guidelines on the procedure of the quality, effectiveness and safety examination of the medical devices for state registration. We monitor all changes in the regulatory field and take them into account when preparing documents for our Clients.

In order to facilitate all market participants, we have prepared a medical device registration chart, which we promptly update, taking into account all changes introduced.


Within the shortest time possible, our experts can develop technical and operational documentation, information on regulatory documentation, an application for registration in full compliance with the requirements of regulatory documents of Roszdravnadzor. In case you have a number of the above listed documents, our experts will examine their compliance with the established requirements. According to the results of this examination, they will carry out adjustment, revision and updating if there is such a need.

Medical products manufactured outside of Russia require an import permit. Our experts can develop a complete set of documentation for the earliest receipt of the necessary permit to import the required number of samples of a medical device for the purposes of testing. This document is subsequently included in the registration dossier

The list of our partners includes authorized testing centers and laboratories which conduct all types of tests required for the successful registration of medical devices. In order to step up the registration process, we can provide simultaneous carrying out of technical and toxicological tests. The duration of clinical trials depends on the type of the medical device and may exceed 30 working days. As for the medical devices related to measuring instruments, they are subject to additional tests which confirm the type of measuring instruments

The list of our partners includes authorized testing centers and laboratories which conduct all types of tests required for the successful registration of medical devices. In order to step up the registration process, we can provide simultaneous carrying out of technical and toxicological tests. Clinical trials for the products of risk classes 2a, 2b, and 3 are carried out on the basis of the issued permission to conduct clinical trials (see the chart below). As for the medical devices related to measuring instruments, they are subject to additional tests which confirm the type of measuring instruments

At this stage, one develops a set of documents that constitute the registration dossier. One checks the availability of all required signatures, visas, seals, as well as the accuracy of documents certification and completeness of information. State fees are paid

The set of documents for the registration dossier is submitted to Roszdravnadzor following the current administrative procedure. Roszdravnadzor checks the compliance of the set of documents to the inventory

Roszdravnadzor checks the completeness and accuracy of the information contained in the application for registration of a medical device and the documents of the registration dossier

The experience of our experts helps to minimize the possibility of requests for additional information and the emergence of critical remarks. However, in some rare cases, Roszdravnadzor may request additional information. In this case, our experts will respond to this request as quickly as possible and ensure that the medical device registration procedure is initiated

Roszdravnadzor checks the completeness and accuracy of the information contained in the application for registration of a medical device and the documents of the registration dossier

The expert organization of Roszdravnadzor conducts an examination of the results and the completeness of tests and trials (technical and toxicological tests, clinical trials, as well as the tests confirming the type of measuring instruments (for medical devices related to measuring instruments))

If the remarks are not eliminated and/or the documents are not submitted within 30 days, Roszdravnadzor will return applications for registration and documents with an explanation of the reasons for their return

At this stage, an examination of the application and documents of the registration dossier is carried out to determine the possibility (or impossibility) of conducting clinical trials of the medical device

This decision is issued as the Order of the Federal Service for Supervision of Healthcare

Roszdravnadzor may request additional information in the form of a request. This is a rare case in the practice of our company since we always prepare documents in accordance with applicable regulatory and directive documentation. Nevertheless, if such a request arrives, our experts will prepare a response in the shortest time possible

When deciding whether to grant permission to conduct clinical trials of the medical device or not, Roszdravnadzor suspends state registration (this is a formality which serves to stop the course of state registration)

After the completion of the registration procedure, Roszdravnadzor issues a registration certificate (RC) - a document of an established form

We always complete the state registration process, even if Clients come to us after receiving a refusal

These are carried out in organizations entitled to conduct clinical trials of medical devices. The list of such organizations is published on the official website of Roszdravnadzor. The website also contains a register of issued permits for conducting clinical trials. Our company only works with reliable organizations on the basis of cooperation agreements.

The application for renewal of registration and relevant documents are returned if they are revealed to contain false information, or are considered incomplete – in case of the foreign product registration this also includes situations when documents are provided without a Russian translation notarized in an established manner. Our experience allows us to reduce the probability of the application return practically to a zero.

Together with the results of clinical trials, one submits to Roszdravnadzor an application for the renewal of the medical device registration (since the registration procedure is suspended for the period of clinical trials). Roszdravnadzor checks the completeness and reliability of the information and makes a decision on the renewal or the return of the application

In case of the return of the application for the registration renewal (in the practice of our work this happens very rarely), we quickly eliminate the shortcomings based on which Roszdravnadzor decided to return the application

Roszdravnadzor may request additional information in the form of a request (when we are in charge of preparing documentation, the probability of requests to add information and eliminate shortcomings is practically zero)

The expert organization of Roszdravnadzor conducts an examination of the results and the completeness of tests and trials (technical and toxicological tests, clinical trials, as well as the tests confirming the type of measuring instruments (for medical devices related to measuring instruments)). After that, it draws up and sends to Roszdravnadzor a conclusion on the results of the quality, effectiveness and safety examination of the medical device. The competence of our experts and cooperation with reliable partner organizations conducting tests and trials ensure the successful completion of the second stage of registration

We always complete the state registration process, even if Clients come to us after receiving a refusal

This decision is issued as the Order of the Federal Service for Supervision of Healthcare

After the completion of the registration procedure, Roszdravnadzor issues a registration certificate (RC) - a document of an established form

Registration according to the rules of the Russian Federation or the EAEU?

As of now, the state registration of medical devices is undergoing a “transitional period”, which ends on December 31, 2021. At the end of this period, the EAEU Registration Rules begin to apply. An important consequence is that if on the 31st of December 31 of 2021 the medical device is undergoing one of the stages of the registration procedure, the applicant will be denied state registration due to the end of force of the Russian Federation rules and the transition to the EAEU rules. Therefore, if you need to register a medical device, we recommend that you do not delay the registration in order to meet the deadlines of the transition period.

Types of products subject to mandatory registration as medical devices

Medical equipment:

  • Devices for cosmetology and surgery;

  • Diagnostic equipment (X-ray equipment, ultrasound equipment, etc.);

  • Analyzers and other laboratory equipment;

  • Products for in vitro diagnosis;

  • Complex technical rehabilitation facilities (electric wheelchairs, robotic prosthetics, etc.);

  • Life support equipment (artificial lung ventilation equipment, dialysis, etc.);

  • Therapeutic devices (ultrasound, radiofrequency treatment, etc.);

  • Dental units;
  • Implants;

  • Other equipment used for medical purposes.

Devices used for medical purposes (dmp):

  • Clothing, shoe covers, and other hospital-wide medical devices;

  • Consumables (reagents, replaceable filters, paper for electrocardiography, etc.);

  • Standard samples, calibrators for analyzers;

  • Suture surgical material;

  • Bandages and other dressings;

  • Surgical instruments;

  • Inspection tools;

  • Medical furniture;

  • Orthoses;

  • Other products used for medical purposes.

Specialized software:

  • Software for analyzing images from diagnostic equipment;

  • Software for managing the information system of medical institutions;

  • Software for telemedicine healthcare services;

  • Other software used for medical purposes.

Documents for the registration of medical devices

In order to develop a registration dossier (a set of documents required for the registration of a medical device) for a product manufactured outside of Russia, the following documents will be required:

  • Documents confirming the registration of the manufacturer as a legal entity (in the country of production);

  • Manufacturer Certificate (if applicable);

  • Approval documents for the registered product (if available);

  • Power of attorney for the authorized representative of the manufacturer in the Russian Federation;

  • Documents confirming the conditions of production;

  • Technical file (if available);

  • Operational documentation, for example, an instruction for use or an operation manual (if available);

  • Photos of the medical device.

Depending on the complexity of the medical device, its risk class, and functional characteristics, the list of documents can change.

Terms for receiving registration certificates for medical devices

The duration of registration depends on the risk class of the medical device, the chosen registration procedure, the required amount of laboratory tests. We register products in a very short time as we carry out the individual steps of the procedure simultaneously where possible, which saves your time and sets us apart from our competitors.

At an average, the registration of medical devices in our company is carried out in the following terms:

  • Class 1 – 6 months;

  • Classes 2a and 2b – 8-10 months;

  • Class 3 – 12 months.

If you already have certain documents from the registration dossier and have completed certain stages of registration, the terms of these services can be significantly reduced.

The circulation of medical devices is subject to state control. Thus, Article 235.1 of the Criminal Code of the Russian Federation states that production of medical devices without a special permit (license) by the officials is liable to a penalty in the form of imprisonment for up to 8 years with a fine of up to 3 million rubles. Following Article 6.33 of the Administrative Code of the Russian Federation, the production or sale of unregistered medical devices by legal entities is punishable by a fine of up to 5 million rubles or administrative suspension of activity for up to 90 days.

What you get if you choose us:

  • A personal expert who prepares the required documentation, all or in part, provides consultations on all issues related to the registration procedure and exercises control at all stages of the registration procedure of your product;

  • Reduced cost of registration since we help you to minimize its time, to avoid repeated submissions, and conduct testing and trials of your product on the most favorable conditions in partner organizations;

  • Direct partnerships with leading authorized laboratories and centers for preclinical and clinical trials, technical and toxicological tests, as well as with major healthcare institutions and medical associations. Therefore, you do not pay any extra cost for the mediation services.

  • Complete transparency of our decisions and actions aimed at obtaining results in the shortest time possible and at the lowest cost;

  • Convenient work procedure ­- you can receive services on a turnkey basis or use our help at a separate stage of registration indicated in the medical device registration chart from above;

  • A reliable assistant in all procedures related to the registration of medical devices (development of products ‘from scratch’, solving technical issues in their production, localization of production in the Russian Federation and many other issues);

  • Actual results instead of the promises that many other market participants make (especially those that are just mediators). That is why we offer our customers a “per-result” post-payment scheme.

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Introduction of amendments to the RC and the registration dossier

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