Registration of medical devices and equipment

The state registration of a medical device is mandatory for all devices to be launched into the Russian market. This procedure is performed to protect public health and consists in issuing a registration certificate. Subject to the Federal Law, medical devices can only be sold after all registration activities have been completed.

State registration of a medical device is a complex multi-stage process requiring specific knowledge and extensive experience. Therefore, it is worth to consult a professional. FCRC provides both comprehensive services for registration of a medical device and assistance in preparing certain documentation and conducting tests. Our experts are deeply experienced in registering medical devices of both Russian and foreign origin. The carefully organized writing of documents and conduction of tests allow us to obtain registration certificates (RC) as fast as possible and with a positive result. Our indicator of positively approved RCs is 97.8%.

IMPORTANT! If medical devices are not registered, this may lead to serious consequences, including penalties, restrictions on business and even administrative or criminal liability.

Purpose and options of medical device registration

Registration of medical devices and equipment is a procedure specially developed for the market circulation of only safe and high-quality products. Available RC means the compliance of a medical device with the stipulated requirements. Registration of a medical device is mandatory for the import, use, sale, and production thereof in Russia.

There are several types of registration procedures:

• State registration of a medical device according to the national procedure of the Russian Federation
• Simplified state registration of devices that are at risk due to the sanctions imposed, according to the Regulation No. 552 of the Russian Government
• State registration of medical devices under the EAEU rules
• Simplified state registration of devices used for COVID-19 prevention and control, according to the Regulation No. 430 of the Russian Government;
• Amendments to the registration certificate and dossier.

Certain services applicable to state registration

In addition to registration activities, we provide the following additional services:

• Consultation and audit of your package of documents/dossier
• Writing of certain documentation required for testing or dossiers
• Conduction of tests: technical, toxicological, clinical. etc.

FCRC’s specialists are ready to help you resolve issues at any stage of registration, prepare all the necessary documents, and obtain the appropriate RC for a device.

Main stages

Here is the following procedure for state registration:

1. To determine the intended use, medical device code and risk class in accordance with the Federal Law.
2. To determine and draft documents required for testing.
3. To inspect the production (since January 1, 2024) for devices of risk classes 2a (sterile), 2b and 3.
4. To determine the list of required tests and find appropriate testing laboratories.
5. To conduct tests and correct the documentation according to test results (if necessary).
6. To collect a package of documentation for the registration dossier.
7. To apply for state registration and dossier documentation.
8. Verification of submissions by Roszdravnadzor employees. Transfer for examination to a subordinate expert institution.
9. Examination in a subordinate expert institution, whose specialists must confirm or refute the quality, effectiveness and safety of a presented medical device.
10. Roszdravnadzor’s decision on state registration, record of an entry into the Register of Medical Devices.

FCRC’s experts will register any medical device: medical equipment, medical products, consumables, medical instruments, IVD equipment, medical furniture, dedicated software.

Medical device risk classes and cost of state duties

All medical devices are divided into 4 classes according to the degree of their risk:

If a medical device is a set of different medical products, it is assigned to the highest class. Risk classes determine the scrutiny and scope of the state examination, which affects the amount of the state duty charged for the examination.

The state fee is paid by an applicant directly to Roszdravnadzor!

Time frame for registration certificate

Registration certificate execution takes a certain part of time. However, the availability of this document allows a medical device manufacturer to legally sell their products within Russia and receive government support in the form of tax benefits and other preferences. The time frame for state registration is subject to the risk class of a medical device and required tests.

Stages and implementation times are indicated in the table below.

Whenever possible, we carry out the registration stages in parallel, which allows us to reduce the time for preparing the documentation and conducting the tests. To find out more about your project and receive a price quote, please apply or call +7 (495) 374-00-19.