The Russian Ministry of Health has announced plans to elevate the regulation of medical device circulation to a new level in the coming years as part of the International Medical Device Regulators Forum (IMDRF). These changes will affect both manufacturers and regulatory authorities – and some of them are already taking effect.
What is changing right now?
On September 1, 2026, the updated Procedure for Conformity Assessment of Medical Devices comes into force. Key innovations include:
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Results of pre‑registration tests can now be submitted in electronic form;
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Reagents and their kits, control materials, calibrators, washing solutions, and culture media are exempt from mandatory technical tests;
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Requirements for the independence of testing and medical organisations have been tightened – they must not be dependent on the applicant.
The new procedure will remain in force until September 1, 2032, replacing Ministry of Health Order No. 885n of August 30, 2021.
At the same time, the Procedure for Safety Monitoring of Medical Devices has also been updated (Order No. 540n of May 26, 2026). Importantly, monitoring now only applies to devices registered under Russian national rules – devices registered under EAEU rules are excluded from its scope. Additionally, the list of reported data has been expanded to include information automatically transmitted by software with artificial intelligence.
What lies ahead?
Within the IMDRF framework, Russia continues to harmonise its national regulations with international approaches. Future plans include further improvements to classification rules, clinical trial requirements, and production inspection procedures.
How does this affect your business?
The new rules are both a challenge and an opportunity. Electronic document flow speeds up processes, and exempting reagents from mandatory technical tests reduces the burden on manufacturers. However, the new requirements for impartiality of testing organisations call for careful selection of partners.
Elibrium is ready to help you with medical device registration under the new conditions
We have many years of experience and a team of qualified specialists in the field of medical device registration. Our services cover the full range of work:
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Preparation and submission of registration dossiers to Roszdravnadzor via the elk.Roszdravnadzor system;
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Development of technical documentation (technical specifications, instruction manuals, qualification test reports, risk analysis);
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Organisation and support of technical tests, toxicological studies, and clinical trials;
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Interaction with government authorities at all stages;
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Registration under both national rules (Government Decree No. 1684) and within the EAEU framework.
We closely monitor industry changes and help our clients adapt to new working conditions.
Contact us to discuss your task – and we will develop an individual registration strategy for your medical device.
