Registration of Medical Devices Using the Example of an Ultrasound Machine

According to Federal Law No. 323-FZ “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation,” a medical device is any equipment, apparatus, instrument, or material used for diagnostic, therapeutic, or preventive purposes. Ultrasound machines are classified as diagnostic equipment and are among the products subject to mandatory state registration.

The registration certificate is issued by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and confirms the safety and quality of the device. Only after obtaining this document can a medical device be lawfully manufactured, imported, sold, and used in Russia and the countries of the Eurasian Economic Union (EAEU).

For ultrasound machines, registration is mandatory regardless of the model type – stationary, portable, or kits supplied as separate components.

Regulatory Framework: What Has Changed Since 2025

Effective 1 March 2025, the new Rules for State Registration of Medical Devices, approved by Government Resolution No. 1684 of 30 November 2024, came into force. This document replaces the rules that had been in effect for over 12 years (Resolution No. 1416 of 2012).

Key changes under the new regulation:

• Consolidation of rules – all registration requirements are now brought together in a single regulatory legal act.

• Shortened timelines – basic registration without clinical trials takes 31 days; minor changes to the dossier take 18 days.

• Stricter requirements for clinical trials – medical organisations conducting trials must have standard operating procedures, and specialists must have appropriate education.

• Digitalisation – from 1 September 2025, clinics are required to upload clinical study data to Roszdravnadzor’s automated information system in electronic format.

• Extension of transition periods – by Resolution No. 1206 of 13 August 2025, the deadline for updating information on authorised representatives of manufacturers was extended to 1 September 2026.

Risk Classes: Where Does an Ultrasound Machine Fit?

All medical devices are divided into four classes depending on the potential risk to the patient:

Ultrasound machines fall into class 2b (elevated risk). The higher the class, the more complex and time‑consuming the registration procedure, and the more documents are required.

Stages of Registering an Ultrasound Machine

The registration process consists of several sequential stages:

1. Preparation of Documentation

At this stage, a full package of documents in Russian is developed:

• technical documentation (technical specifications, device passport);

• operating manual;

• qualification test reports;

• risk analysis file;

• photographic images of the device;

• a set of regulatory and legal documentation.

2. Conducting Tests

The ultrasound machine undergoes a comprehensive set of tests in accredited Russian laboratories:

• Technical tests – verification of compliance with safety requirements.

• Toxicological studies – assessment of the biocompatibility of materials.

• Electromagnetic compatibility – checking that the equipment operates without causing interference.

3. Clinical Trials

For ultrasound machines, clinical trials are conducted in medical organisations that have the appropriate accreditation. The results of the trials confirm the efficacy and safety of the device for diagnostic purposes.

4. Submission of Documents to Roszdravnadzor

The completed package of documents is submitted via the electronic system elk.Roszdravnadzor. The applicant may be the manufacturer or its authorised representative in the Russian Federation.

5. Expert Review and Decision

Roszdravnadzor carries out an expert review of the submitted documents. If the outcome is positive, a registration certificate is issued, and information about the device is entered into the state register of medical devices.

Important Nuances for Ultrasound Equipment

When registering ultrasound devices, several specific points should be considered:

1. HS code – ultrasound scanners are classified under code 9018 12 000 0.

2. Compliance with technical regulations – the equipment must comply with TR CU 032/2013, GOST R 50444-2019, and GOST ISO 13485-2017.

3. Interchangeability – the new rules establish the inadmissibility of unjustified restriction of interchangeability of medical devices.

4. Transition period – registration certificates issued under the old rules (No. 1416) remain valid indefinitely; however, making changes to them will be restricted after 31 December 2026.

Conclusion

Registering a medical device is a complex and multi‑stage process that requires in‑depth knowledge of legislation, meticulous attention to document preparation, and interaction with regulatory authorities. Errors at any stage can lead to delays, additional costs, and even refusal of registration.

This is especially relevant in the context of the transition to the new rules (Resolution No. 1684), where the regulatory framework has undergone significant changes and many procedures have become digital.

Elibrium is ready to be your reliable partner in medical device registration – from market analysis to obtaining the registration certificate and subsequent support.

The company’s specialists provide a full range of services:

• development of technical documentation (technical specifications, operating manual, risk analysis);

• conducting technical, toxicological and clinical tests;

• preparation and submission of the registration dossier through the Roszdravnadzor system;

• escorting the registration process and handling regulator comments;

• obtaining the registration certificate;

• advisory support for the certificate holder throughout the year.

Elibrium closely monitors industry changes and helps clients adapt to new working conditions. By contacting the company, you gain expert approach, control at all stages, and minimisation of risks when registering your ultrasound machine or any other medical device.