Registration of Medical Devices Using the Example of a Hip Endoprosthesis

Entering the Russian market with implantable medical devices is a fundamentally more complex task than registering diagnostic equipment or laboratory reagents. Endoprostheses fall into Class 3 – the highest level of potential risk to the patient. Their implantation involves surgery and long‑term presence in the body, which is why regulatory requirements here are the strictest. Using a hip endoprosthesis as an example, we will explore how the registration process works, which tests are mandatory, and what to pay special attention to in 2025–2026.

What Is an Endoprosthesis as a Medical Device?

Under Federal Law No. 323‑FZ, endoprostheses are medical devices used to replace lost bodily functions. Unlike ultrasound machines or in vitro reagents, an endoprosthesis directly contacts human tissues for many years. That is precisely why they are assigned to Class 3 – the highest requirements for safety, efficacy, and durability.

The registration certificate is issued by Roszdravnadzor and grants the right to manufacture, import, and use the device in Russia and the EAEU member states. Without it, the implant cannot be sold or even imported for clinical trials.

Regulatory Framework: What Has Changed Since 1 March 2025

On 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. For implant manufacturers, the key changes are:

• Registration Monitoring Plan – for Class 2b and 3 devices, this document is now mandatory. It enables Roszdravnadzor to track the usage dynamics of implants, identify potential problems, and take timely corrective measures.

• Alternative evidentiary materials – the new rules allow the inclusion of scientific publications and other sources instead of some traditional documents, which is particularly relevant for innovative developments.

• Digital submission – all documents are submitted through the State Services personal account and the Roszdravnadzor electronic cabinet using a qualified electronic signature.

• Transition period – registration of devices submitted before 28 February 2025 is processed under the old rules (Resolution No. 1416), while submissions from 1 March follow the new rules. Certificates issued previously remain indefinitely valid, but changes to them can be made only until 31 December 2026.

• Stricter document requirements – all files must be colour, with a resolution of at least 300 dpi, in PDF format, and each file size must not exceed 100 MB.

From 1 September 2025, additional requirements came into effect: foreign manufacturers must appoint an authorised representative in Russia and include this information in the registration dossier (deadline – 1 September 2026), and mandatory per‑unit tracking through the “Honest Sign” system was launched.

Stages of Registering an Endoprosthesis: From Laboratory to Operating Room

The registration process for a Class 3 implant is significantly more complex and time‑consuming than for lower‑class devices.

1. Development of Technical Documentation

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

• technical specifications (TU) with detailed description of design, materials, and manufacturing processes;

• instructions for use and surgical implantation guidelines;

• risk analysis file – critically important for endoprostheses, covering all possible failure scenarios (wear, corrosion, loosening of components);

• high‑resolution photographs of the device;

• documents confirming the manufacturer’s quality management system.

For implants, documented proof of sterility and storage conditions is particularly important.

2. Technical and Toxicological Tests

The endoprosthesis undergoes a comprehensive set of studies in accredited laboratories:

• Mechanical tests – assessment of strength, wear resistance, fatigue endurance (simulating load cycles corresponding to years of use).

• Toxicological studies – evaluation of biocompatibility of materials (titanium alloys, cobalt‑chromium alloys, polyethylene, ceramics). Cytotoxicity, sensitisation, tissue irritation, and systemic toxicity are examined.

• Sterility and pyrogenicity tests – critically important parameters for any implant.

3. Clinical Trials – The Most Critical Stage

For Class 3 endoprostheses, clinical trials are mandatory and conducted in accredited medical organisations – typically in federal medical research centres under the Ministry of Health. The trials include:

• Preclinical studies on biological models (experimental animals) to assess osseointegration and tissue response.

• Clinical studies with patients requiring arthroplasty. Follow‑up lasts for a defined period (usually at least 1–2 years) with evaluation of functional outcomes, quality of life, and complication rates.

From 1 September 2025, all clinical study data must be uploaded to Roszdravnadzor’s automated information system in electronic format within three working days after the study is completed.

Important: clinical trials for implants are the most expensive and time‑consuming part of registration. Errors in study design or insufficient patient cohorts are common causes of refusals and delays.

4. Preparation and Submission of the Registration Dossier

The document package includes all the above materials, plus:

• the mandatory Registration Monitoring Plan – a new document describing how the manufacturer will collect and analyse safety data after market entry;

• information on production sites and the quality management system;

• documents confirming the manufacturer’s domestic status (if applicable).

Submission is carried out through the Roszdravnadzor electronic system.

5. Expert Review and Registry Entry

Roszdravnadzor conducts an expert review of the submitted documents. The review period for Class 3 is up to 50 working days (when clinical trials are included). If the decision is positive, a record is made in the state register – this is the official confirmation of registration. Paper certificates are no longer issued.

Specific Features That Distinguish Implant Registration

Here is what fundamentally sets endoprosthesis registration apart from registering ultrasound machines or reagents:

1. Long‑term clinical data – implants require evidence not only of short‑term but also long‑term safety (wear resistance, osseointegration, absence of rejection). This means clinical trials last for years.

2. Post‑market surveillance – after registration, the manufacturer is obliged to continuously collect data on each implanted device. The new Registration Monitoring Plan formalises this obligation.

3. Model grouping – the new rules allow multiple variants of an endoprosthesis to be included in a single registry entry, provided certain conditions are met: the same manufacturer, identical technical documentation, and the same risk class. This reduces the number of separate registrations.

4. “Honest Sign” – since September 2025, each device must have a marking code, and all shipments are recorded in electronic document flow. For implants, this means traceability from production to the operating room.

5. Special procedure during shortages – from 1 March 2025, the registration procedure is simplified in cases of deficit or risk of deficit due to sanctions. This may be relevant for critically important implants.

Outlook: Transition to EAEU Rules

From 1 January 2026, registration of medical devices must follow the unified rules of the Eurasian Economic Union. The national system will only apply to applications submitted earlier. However, some market participants doubt the readiness of the unified information system, so parallel use of the national system is allowed until the transition period ends. Implant manufacturers should plan their registration strategy well in advance, taking this transition into account.

Conclusion

Registering a hip endoprosthesis is one of the most complex and costly processes in the field of medical device circulation. The high risk class, mandatory long‑term clinical trials, stringent biocompatibility requirements, and post‑market controls demand not only financial resources but also deep expertise from the manufacturer.

The 2025 new rules (Resolution No. 1684) have on one hand tightened requirements (Registration Monitoring Plan, digitalisation), and on the other offered acceleration mechanisms (alternative evidentiary materials, model grouping). The success of registration directly depends on a proper strategy at every stage – from choosing an accredited laboratory to compiling a well‑structured dossier.

Elibrium is ready to be your reliable partner in registering medical devices of any risk class, including implants and endoprostheses.

We offer a full range of services:

• analysis and determination of the optimal risk class and registration strategy;

• development and translation of technical documentation (specifications, instructions for use, risk analysis);

• arrangement of technical, toxicological and clinical trials in accredited centres and federal medical research centres;

• preparation of the Registration Monitoring Plan for Classes 2b and 3;

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

• support during the expert review and prompt handling of regulator comments;

• obtaining the registry entry and post‑registration support;

• consultations on marking under the “Honest Sign” system and preparation for the transition to EAEU rules.

Elibrium closely monitors all legislative changes and helps clients adapt to new conditions. By choosing us, you gain expert approach, control at all stages, and minimisation of risks when registering your endoprosthesis or any other medical device.