Registration of medical devices

Registration of medical devices is a state procedure designed to ensure that only high-quality and safe products are available on the Russian market.

The following are subject to state registration:

  • any instruments, apparatus, devices, equipment, materials and other products that are used for medical purposes separately or in combination with each other, as well as together with other accessories;
  • special software.

In order for the listed devices to be classified as medical, their purpose must be one of the following or a combination of them:

  • preventive treatment,
  • diagnostics,
  • disease treatment and medical rehabilitation,
  • monitoring the state of the human body,
  • medical investigation,
  • regeneration,
  • restoration,
  • changes in the anatomical formations or physiological functions of the body,
  • prevention or termination of pregnancy.

The functional use of medical devices is unrelated to pharmacological, immunological, genetic or metabolic effects on the human body.
Medical devices are not subject to state registration if they are:

  • made according to individual orders of patients,
  • strictly reserved for personal use
  • those for which special requirements are imposed regarding the appointment of medical workers and specific patients.

Registration of medical devices is carried out by the Federal Service for Surveillance in Healthcare (abbreviated name — Roszdravnadzor).
State registration of medical devices is carried out on the basis of the following test and inspection results:

  • technical tests,
  • toxicological studies on applicability,
  • clinical investigations,
  • tests in order to approve the type of measuring instruments on applicability,
  • examination of the quality, effectiveness and safety of medical devices.

Roszdravnadzor, based on the documentation investigation findings, issues a non-expiring Registration Certificate for a medical device.
On the territory of Russia, only such medical devices that have registration certificates or which are not subject to registration are allowed to circulate.

The circulation of medical devices refers to the following stages of testing and inspection:

  • production,
  • manufacturing,
  • transportation,
  • import into the territory of the Russian Federation,
  • toxicological studies,
  • technical tests,
  • clinical investigations,
  • examination of the quality, effectiveness and safety of medical devices,
  • state registration,
  • export from the territory of the Russian Federation,
  • confirmation of compliance,
  • state control,
  • storage,
  • sales, installation,
  • adjustment, application,
  • operation,
  • maintenance,
  • repairs,
  • recycling or disposal.

The law provides for administrative and criminal liability for illegal manufacture of medical devices, circulation of faked, poor-quality, counterfeit and unregistered medical devices, forgery of documents for medical devices or their packaging.

To familiarize yourself with the specifics of registering foreign-made products, go to the Registration of medical devices page of the site.

To register Russian-made products, go to the Registration of Russian-made medical devices page.

The list of reasons for making changes to the documents contained in the registration dossier can be found on the page Making changes to the documents of the registration dossier.

We have posted information on the execution of a duplicate registration certificate in the same section. You will need a duplicate if you have lost or damaged the registration certificate.

We have started the registration process for several projects under the new rules. You will find answers to the questions “What are these new rules and what are their special aspects?” on the page Registration according to the EAEU rules.

It is possible that your questions are already answered in the FAQ section. If you do not find an answer, then contact our specialist in a convenient way for you (by phone 8-800-201-27-87, by e-mail info@medexpert.ru, via an online chat on the website or via WhatsApp and Viber, as well as with the aid of our Vkontakte group).

Our offices in Moscow and St. Petersburg are open for your calls and visits.

In St. Petersburg, specialists are ready to answer your questions at a convenient time for you from 8:30 to 20:00 on weekdays.