Obtaining a medical device registration certificate


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Obtaining a medical device registration certificate

It may take as long as 18 to 24 months to get a medical device registered and be issued a registration certificate if the procedure is performed on one’s own. Medalis offers a turnkey solution for prompt and secure registration of medical devices. We will manage the gathering of documents, testing by an accredited laboratory, logistics support and customs clearance, and will help you get the medical device registered under the EAEU regulations.

Meaning of a registration certificate and its intended purpose

A registration certificate for a medical device is a document confirming that a particular medical product is included in the State Register of Medical Devices and can be freely manufactured in or imported to the Russian Federation for its subsequent sale and use. Both Russian and foreign companies registered under the current laws of the Russian Federation can be issued a registration certificate.

According to Decree No. 1416 of the Government of the Russian Federation dated December 27, 2022 “On Approval of the Rules for State Registration of Medical Devices”, any tools, equipment, materials and other products, as well as other fixtures and software intended for medical applications (hereinafter referred to as “medical devices”) are subject to state registration.

The manufacture, sale and use of medical devices without a registration certificate are penalized by suspension of business and imprisonment of the responsible person or by a fine of up to 2 million rubles.

Validity period of a registration certificate

The Federal Service for Supervision of Healthcare (Roszdravnadzor) issues registration certificates in accordance with regulations of the Eurasian Economic Union (EAEU). In the EAEU member states (Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia), registration certificates are valid for an indefinite period. As of January 1, 2022, registration under national regulations of the EAEU member states was terminated.

Cost of obtaining a registration certificate

Cost of obtaining a registration certificate Cost of obtaining a registration certificate Cost of obtaining a registration certificate
Cost of obtaining a registration certificate 50 000 RUB

Factors determining the price and time frame of obtaining a registration certificate

The first step in the preparation for registration of a medical device is to identify its risk class. Also, particular attention needs to be paid to the complexity of design of the medical device, its intended use, number of available versions, and so on. The higher the risk class of a medical device is, the more time and effort it requires, leading to the increase of duration and overall cost of our work.

Classes of medical devices:


  • Risk Class 1 (clothing, scales, specialized sterile containers, etc.);
  • Risk Class 2a (laboratory equipment and instruments);
  • Risk Class 2b (ventilators, defibrillators, etc.);
  • Risk Class 3 (implants, endoprostheses, lithotripters, etc.).

Both the amount of state fees and the cost of expert services for evaluation of efficacy, quality and safety vary depending on the risk class. Registration takes up to 10 months for Class 1, up to 14 months for Class 2a, and up to 16 months for Classes 2b and 3.

Stages of state registration of Risk Class 1 medical devices


  • Arranging the procurement of a permit to import samples of the medical device in question for the purpose of its state registration (where the medical device is manufactured abroad);
  • Completing and revising legal, technical, operational and reference documentation;
  • Arranging the performance of and conducting toxicity tests, technical tests, and electromagnetic compatibility (EMC) tests;
  • Collecting and evaluating information on the clinical use of the medical device; setting up a program for clinical trials and conducting them;
  • Filing an application with the Registering Authority for state registration of the medical device to be accompanies with a documentation package;
  • Roszdravnadzor processing the documents;
  • The Registering Authority submitting the documentation package and issuing an assignment for assessment of quality, efficacy and safety of the medical device to a specialized Expert Organization;
  • Roszdravnadzor making a decision on state registration;
  • Obtaining a registration certificate from the Registering Authority.

Stages of state registration of risk class 2a, 2b and 3 medical devices


  • Arranging the procurement of a permit to import samples of the medical device for the purposes of state registration (where the medical device is manufactured abroad);
  • Completing and revising the legal, technical, operational and reference documentation;
  • Arranging the performance of and conducting toxicity tests, technical tests, and electromagnetic compatibility (EMC) tests;
  • Filing an application with the Registering Authority for state registration of the medical device to be accompanies with a documentation package;
  • Roszdravnadzor processing the documents;
  • The Registering Authority submitting the documentation package and issuing an assignment for assessment of quality, efficacy and safety of the medical device to a specialized Expert Organization;
  • The Expert Organization issuing a permit for performance of clinical trials of the medical device; suspension of the registration process for the period of clinical trials;
  • Collecting and evaluating information about the clinical use of the medical device; setting up a program for clinical trials and conducting them;
  • Submitting the results of clinical trials and resuming the state registration process;
  • Roszdravnadzor making a decision on state registration;
  • Being issued a registration certificate by the Registering Authority.

Documents to be submitted to Roszdravnadzor

Domestic manufacturers of medical devices are to provide the following documents for the purposes of obtaining a registration certificate:


  • An application for state registration of the medical device;
  • A power of attorney in the name of the company’s authorized representative, empowering him/her to perform legal acts, if necessary;
  • Information on reference documentation for the medical device;
  • Technical and operational documentation for the medical device;
  • Photographs of the medical device;
  • Documents certifying the results of technical, toxicity and EMC testing (for electrical equipment) of the medical device;
  • Information certifying clinical efficacy and safety of the medical device;
  • A payment order, certifying the payment of state fees for the expert assessment of quality, efficacy and safety performed by a specialized organization;
  • A payment order certifying the payment of state fees for issuance of the medical device registration certificate;
  • A Risk Management File (RMF), containing the projection, assessment and management of risks associated with operation of the medical device;
  • A packaging validation report;
  • A sterilization validation report (for devices to be supplied sterile);
  • A shelf life report for the medical device.

For medical devices manufactured abroad, the following documents are to be provided for the purposes of obtaining a registration certificate:


  • A permit to import samples of the medical device to the Russian Federation (if the medical device is manufactured abroad);
  • Registration documents, declarations of conformity and certificates issued in the manufacturer’s country;
  • An extract from the trade register.

Documentation for foreign-made medical devices must be provided with a notarized translation..

Procedure for obtaining a registration certificate from the Registering Authority

Preparation of documents
Testing of medical devices:
  • Technical tests
  • Toxicity tests
  • Clinical trials
  • Tests for approval of the measuring instrument pattern, if necessary
  • Tests to confirm electrical safety
  • Tests for compliance with electromagnetic compatibility (EMC) requirements
Compiling a registration dossier
for state registration of medical devices
Registration of medical devices
(I stage)
Processing of documents
Correction of deficiencies
(if necessary)
(Stage I)
Assessment of quality, performance and safety of medical devices
Request for necessary materials
(if necessary)
Making a decision on state registration

Our services

Medalis assists both Russian and foreign manufacturers of medical devices in obtaining registration certificates. If you have no opportunity or time to study the legal framework, search for a laboratory, or coordinate details with Roszdravnadzor, we can:


  • Offer you a turnkey solution for registration of your medical device under the EAEU and national regulations;
  • Assess whether your registration dossier has been completed correctly and in full;
  • Arrange the performance of technical testing, toxicity testing, clinical trials, and electromagnetic compatibility (EMC) testing by laboratories of Eleсtrontest Group;
  • Develop technical and operational documentation and an instruction for use for your medical device in accordance with requirements of Roszdravnadzor;
  • Coordination of and introduction of revisions to your registration dossier under the EAEU regulations.

Medalis is a member of Eleсtrontest Group that has been present on the market of medical devices for more than 12 years. The Group comprises laboratories that perform technical, clinical diagnostic, and toxicity testing and have a confirmed status from the Federal Accreditation Service. We cooperate with research organizations that test products from Boston Scientific, Mindrey, and Johnson. We offer a transparent registration process, convenient working arrangements with a personal expert, and reduced registration costs, and will make sure you receive a registration certificate at the first attempt.

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Our group of companies

The Elecrontest Group of Companies has been operating in the medical device circulation market for more than 10 years. During its existence, more than 600 registration certificates have been successfully obtained.

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