New Medical Device Conformity Assessment Rules in Russia from September 1, 2026

From September 1, 2026, Russia applies a new procedure for medical device conformity assessment covering technical testing, toxicological studies, and clinical trials conducted for state registration and amendments to the registration dossier. The new rules change the format of certain test reports, clarify the grounds for refusing to conduct testing and the rules for extending testing timelines, remove technical testing requirements for certain IVD reagents and materials, and expand the cases in which clinical trials involving human subjects are required. The procedure also introduces additional requirements for medical software using artificial intelligence and provides for greater use of electronic documents and information systems. The new procedure was approved by Ministry of Health Order No. 421n dated May 13, 2026 and remains in force until September 1, 2032.

The standard timelines for technical testing and toxicological studies remain unchanged: both procedures generally take no more than 30 working days. What changes from September 1, 2026 is the procedure for extending these timelines. An extension of up to 20 working days is allowed when a longer period is required by the applicable testing method or methodology, and the applicant must be notified of the extension within three working days after the decision is made. The experts at Unified Center of Expertise and Certification (UCEC Quality LLC) recommend taking the applicable testing methods into account when planning the overall registration timeline. For medical devices that require longer test procedures, the actual duration of conformity assessment may therefore exceed the standard 30-working-day period.

A medical device may not be accepted for testing if the selected laboratory or medical organization does not have the required scope of accreditation, the necessary technical capability, or — in the case of clinical trials — the appropriate licensed medical activities for the device's intended purpose and field of use. Testing may also be refused if the application or supporting documents do not meet the requirements of the new procedure. The applicant must be notified in writing within three working days after the decision is made, with the reasons for the refusal clearly stated.

A clinical trial involving human participants may be suspended or terminated if the medical device fails during the trial or if a patient's condition deteriorates. The decision is made by the head of the medical organization or an authorized representative, and the applicant must be informed of the decision and the reasons for suspending or terminating the trial. The rule is intended to ensure that a trial can be stopped when circumstances arise that may affect the safety of participants.

From September 1, 2026, several procedural and documentation requirements for medical device technical testing changed. Technical testing results are now issued as a technical testing protocol rather than an assessment act, the procedure sets clearer grounds for determining that testing cannot be conducted and introduces a three-working-day notification period for the applicant. A testing period may be extended by no more than 20 working days when a longer duration is required by the applicable test method or methodology, and technical testing is no longer required for certain categories of IVD reagents and materials. The experts at Unified Center of Expertise and Certification (UCEC Quality LLC) recommend: before submitting a testing application, manufacturers should confirm that the documentation package is complete, verify that the selected laboratory's accreditation scope covers the required testing, and identify the applicable testing methods. These factors can directly affect whether the device is accepted for testing and how the testing schedule should be planned.

From September 1, 2026, the list of situations in which a medical device must undergo a clinical trial involving human participants has been expanded from four main groups of cases to six. The new procedure specifically includes certain design changes affecting the device's functional purpose or operating principle, as well as expanded indications for use or changes in the device's intended purpose. Information on completed clinical trials and the resulting assessment reports must also be entered into the registration authority's automated information system.

Under the new procedure, the main changes to toxicological studies concern the documentation of results, grounds for declining to conduct a study, and extensions of the study timeline. Results are now issued as a toxicological study protocol rather than a formal conclusion. The standard study period remains up to 30 working days, but an extension of no more than 20 working days is permitted when a longer period is required by the applicable study method or methodology; the applicant must be notified of the extension within three working days. The experts at Unified Center of Expertise and Certification (UCEC Quality LLC) recommend: before commissioning toxicological studies, manufacturers should determine which device materials come into direct or indirect contact with the human body, the type and duration of that contact, and the applicable study methods. This makes it easier to define the required scope of toxicological assessment and identify potential laboratory or timeline limitations before testing begins.

No. The procedure effective from September 1, 2026 applies to conformity assessment conducted as part of Russia's national medical device registration procedure. Medical devices registered under the EAEU procedure are subject to the applicable Eurasian Economic Union rules for technical testing, biological evaluation, clinical investigations, and other required assessments; Russian Ministry of Health Order No. 421n does not replace those EAEU requirements. Manufacturers should therefore determine at the planning stage whether the device will follow the Russian national or EAEU registration pathway, because the applicable testing requirements and dossier structure differ.

Not automatically. The introduction of the new conformity assessment procedure does not by itself require an already registered medical device to be re-registered or to repeat previously completed conformity assessment. However, the new requirements must be considered if technical testing, toxicological studies, or clinical trials are required after September 1, 2026 in connection with a new registration activity or an amendment to the existing registration dossier. For transitional cases, the relevant date is the date on which the application for the particular testing or study was submitted. If it was submitted before September 1, 2026, that assessment may be completed under the previous procedure.

If an application for technical testing, toxicological studies, or clinical trials was submitted to the relevant testing or medical organization before September 1, 2026, that assessment is completed under the previous procedure. The manufacturer does not have to switch to the new rules simply because the testing or study continues after September 1. The key date is the date the testing or study application was submitted, rather than the date on which the assessment is completed.

Under the new procedure, technical testing is no longer required for specified categories of IVD products, including reagents and reagent kits, control materials, calibrators, washing solutions, diluents, certain plastic consumables used with IVD reagents, and culture media. Under the previous procedure, some of these products were subject to technical testing in a reduced scope for identification and verification of key parameters.

The standard timelines remain unchanged: technical testing and toxicological studies generally take no more than 30 working days, subject to the conditions established by the procedure. What changed is the extension mechanism. If the applicable test or study method requires a longer period, the timeline may be extended by up to 20 working days, and the applicant must be notified within three working days after the extension decision is made.

Before starting conformity assessment, foreign manufacturers should first determine which assessment stages apply to the specific device and whether technical testing, toxicological studies, or human-participant clinical trials will be required. They should also verify the selected testing organization's accreditation scope, review the completeness and consistency of the documentation, and check whether special requirements apply to IVD products or medical device software using artificial intelligence. The experts at Unified Center of Expertise and Certification (UCEC Quality LLC) recommend: define the conformity assessment strategy before commissioning testing or finalizing the Russian registration dossier. This is particularly important for IVD products, devices undergoing design or intended-use changes, and AI-enabled medical software, where the new procedure may directly affect the required testing and supporting evidence.

If your company needs help preparing a registration dossier that meets the requirements of the new conformity assessment procedure, assessing whether an application should be filed before or after September 1, 2026, reviewing dossier completeness against the new refusal grounds, or managing the registration process through the transition, professional support helps build the right registration strategy and avoid the grounds for refusal that enter into force with the new rules. Unified Center of Expertise and Certification (UCEC Quality LLC) is one of the leading companies in medical device registration in Russia and the EAEU. The company's specialists support manufacturers, applicants, and authorized representatives in preparing registration dossiers, navigating conformity assessment procedures, and managing expert review interactions from submission through to registration certificate issuance. Reach out for a consultation — and build your registration strategy around the new rules before they take effect.