Registration of medical devices according to the Russian Federation rules
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.
Registration according to the rules of the Russian Federation or the EAEU?
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.
