Dear colleagues! As of today, September 1, 2026, updated rules for conducting technical, toxicological, and clinical trials of medical devices come into effect in Russia. The new procedure is approved by Ministry of Health Order No. 421n of May 13, 2026 and replaces the previously effective Order No. 885n. The document was registered with the Ministry of Justice on June 1, 2026 and will remain in force until September 1, 2032.
Why is this important?
The new procedure was developed as part of the "regulatory guillotine" and aims to unify the medical device assessment procedure, increase process transparency, and reduce regulatory barriers. For manufacturers and importers, this means clear and predictable timelines, as well as new documentation requirements that must be taken into account from the first day of the order's validity.
Key changes
1. New formats of final documents
This is perhaps the most important practical change. The composition and naming of documents issued based on assessment results are changing.
Previously, under Order No. 885n, technical tests were documented in an act of evaluation of technical test results (separately for medical devices and for in vitro diagnostic medical devices). Toxicological studies were documented in a conclusion. Now, under new Order No. 421n, both technical and toxicological studies are completed with protocols. Instead of two types of acts for technical tests, there is now a unified protocol of technical tests. Instead of a toxicological conclusion, there is a toxicological study protocol. The formats of documents for clinical trials have not changed – the act of evaluation of clinical trial results remains unchanged.
2. Electronic document flow is now directly established
The new procedure directly provides that conformity assessment results are issued on paper or in the form of an electronic document signed with an electronic signature. Information on conducted clinical and clinical-laboratory tests must be entered into the Roszdravnadzor information system. This aspect was not regulated under Order No. 885n.
3. Clear timeline regulation
Order No. 421n establishes specific timeframes for interaction between testing organisations and applicants.
No more than 10 working days are allotted for reviewing an application for testing from the date documents are received. Then, within 3 working days, the testing organisation must notify the applicant of the possibility or impossibility of conducting tests. The technical and toxicological tests themselves must be completed within no more than 30 working days from the date samples are provided. If necessary, this period may be extended, but by no more than 20 working days.
4. Grounds for human clinical trials expanded
Two new cases have been added to the previous grounds where clinical trials with human participation will be required:
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changes to the design of the medical device that directly affect its functional purpose or principle of operation;
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expansion of the list of indications for use or a change in the intended purpose of the medical device.
5. Exemption from technical testing
Reagents and their kits, control materials, calibrators, washing solutions, diluents, plastic consumables for in vitro diagnostics, and culture media are now exempt from mandatory technical testing.
What is important to know?
The new procedure is "linked" to the new rules of state registration of medical devices, approved by Government Decree No. 1684 of November 30, 2024. This means that the completeness of the application must now be verified not against the order, but against the current registration rules.
Important! If an application for testing was submitted before September 1, 2026, the conformity assessment will be conducted under the old rules (Order No. 885n). For all new applications from September 1, the new procedure applies.
How can Elibrium help?
We have many years of experience in the field of medical device registration and offer a full range of services for organising testing in accordance with the new requirements:
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analysing the need for and developing a testing programme taking into account the type and class of your device and the new grounds for clinical trials;
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selecting accredited laboratories and medical organisations from the official register;
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preparing and processing all necessary documentation taking into account the new protocol formats;
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coordinating interaction between the applicant and testing centres;
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quality control of protocols and reports in accordance with the new requirements.
Contact us to discuss your task and get a cost estimate for our services. We will help you go through all stages of testing in accordance with the new rules without risks or delays.
