On May 15, 2026, the updated procedure for consulting applicants on state registration of medical devices came into force, approved by Roszdravnadzor Order No. 132 of February 16, 2026. The document replaces the regulation that had been in effect since 2017 and introduces a fundamentally new format for interaction between the regulator and market participants.
Key innovation: preliminary dossier review
For the first time, the consultation procedure includes a preliminary analysis and assessment of the registration dossier prior to formal submission of the application. This allows applicants to identify regulatory risks in advance, verify the completeness of materials, and adjust documentation before the main expert review begins. This mechanism is expected to reduce the number of refusals and shorten application processing times.
Who provides consultations?
Consultations are conducted by two subordinate expert institutions of Roszdravnadzor:
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FSBI "VNIIIMT" – quality, efficacy and safety expertise, technical and clinical expertise of complex equipment and high‑tech devices;
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FSBI "National Institute of Quality" – a broad range of medical devices, consumables, and software solutions.
Expanded list of consultation topics
The updated consultation topic list now includes:
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classification of medical devices by risk class and nomenclature types;
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classification of a product as a medical device, including software and software using artificial intelligence technologies;
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in vitro diagnostic devices;
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the possibility of including multiple models in a single registry entry;
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the need for clinical trials involving human subjects;
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preparation of clinical monitoring plans for high‑risk and implantable devices;
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composition of the registration dossier, requirements for technical and clinical documentation;
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assignment of OKPD2 codes.
How does the consultation work?
Consultations are conducted exclusively on the basis of a contract concluded between the applicant and the expert institution. The service may be provided orally or in writing, with a service delivery period of up to 20 working days from the start of work under the contract. Oral consultations (in‑person or online) are recorded on audio and video, and the recordings are retained for at least one year.
Important limitation: conflict of interest prevention
Experts who conducted consultations or production inspection audits may not subsequently participate in the quality, efficacy and safety expert review of the same medical devices. Consultants are also not permitted to assess the dossier on behalf of Roszdravnadzor or predetermine the regulator's decision – the consultation represents the institution's expert opinion, not a preliminary approval of registration.
The procedure remains voluntary
Consultation remains voluntary and is not a mandatory condition for obtaining the state service of registration. However, for businesses, this is a formalised tool for risk minimisation: access to the expertise of professionals who work with registration dossiers daily allows for a robust document preparation strategy.
Elibrium will help you make effective use of the new consultation tool in medical device registration
We have extensive experience in the field of medical device registration and offer a full range of services:
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strategic consulting on choosing the optimal registration pathway;
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preparation and submission of applications for consultation to Roszdravnadzor's expert institutions;
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preparation of registration dossiers taking into account recommendations received during preliminary analysis;
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preparation of documentation for technical, toxicological, and clinical trials;
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full support of state registration with Roszdravnadzor;
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consulting on classification issues, including software and AI solutions.
Contact us to discuss your task – we will help reduce regulatory risks and ensure successful registration of your medical device.
