Technical testing is a mandatory stage of conformity assessment for a medical device during its state registration in Russia. Its purpose is to determine the quality and safety of the device and to verify that its characteristics comply with the requirements of regulatory, technical, and operational documentation from the manufacturer.
Technical testing evaluates the mechanical, electrical, and functional parameters of the device, its reliability and operational stability, electrical safety, electromagnetic compatibility, and the compliance of the characteristics stated in the documentation with actual performance indicators.
New rules from September 1, 2026
On September 1, 2026, an updated procedure for conducting technical testing comes into force, approved by Ministry of Health Order No. 421n of May 13, 2026. It will replace the previously effective Order No. 885n.
Key innovations:
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Test results can be documented in both paper and electronic form;
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Information on conducted tests must be entered into the Roszdravnadzor information system;
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Clear timelines are established: application review – no more than 10 working days, testing – no more than 30 working days from the date of sample provision;
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Testing organisations must adhere to the principles of impartiality and independence from the applicant.
Exemption from technical testing
An important change: technical testing is now not conducted for reagents, reagent kits, control materials, calibrators, washing solutions, diluents, plastic consumables for in vitro diagnostics, and culture media.
Why this matters
The absence of technical testing or errors in the research programme become grounds for requests for clarification, return of materials for revision, or refusal of registration. Therefore, correct task setting and conducting tests according to relevant standards are critical for successful registration.
Elibrium will conduct technical testing for your medical device
We offer a comprehensive solution for successful technical testing in accredited laboratories:
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direct contracts with leading accredited laboratories in Russia;
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development and approval of a testing programme tailored to your specific device;
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full support throughout the entire process from start to obtaining the protocol;
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minimisation of repeat testing risks through accurate selection of methodologies;
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consulting on the interpretation of results.
Why choose us?
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Many years of experience in medical device registration;
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A rational approach to selecting laboratories and methodologies;
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Fixed pricing and transparent reporting;
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A personal manager to coordinate all work.
Contact us through our website, and our specialists will promptly calculate the cost of technical testing for your device. We will ensure full process support and provide a high-quality protocol necessary for successful registration.
