Roszdravnadzor, the Russian Federal Service for Surveillance in Healthcare, intends to amend the administrative rules for the Medical Device Clinical Trial Registry. It is proposed to extend the validity of this document to 31 December 2028. The draft order is open for public consultation, and the deadline for comments is 7 August 2026.
https://vademec.ru/news/2026/07/23/deystvie-poryadka-vedeniya-reestra-ki-medizdeliy-mogut-prodlit-do-kontsa-2028-goda/
The current version of the Rules for Maintaining the Medical Device Clinical Trial Registry was issued and implemented in July 2025. It replaced two former regulatory documents:
Order No. 4220‑Пр/13 dated 19 August 2013 on the forms of permits for medical device clinical trials
Under the original provisions, this new regulation was set to expire on 31 December 2026. The draft proposed by Roszdravnadzor seeks a direct 2‑year renewal to continue this electronic registry system.
The registry is a public electronic database containing information on all approved medical device clinical trial permits. Mandatory data fields include:
Date and reference number of the clinical trial permit
Medical device name, NKMI classification and risk class
Manufacturer, authorised representative and manufacturing site information
Clinical trial details, including participating medical institutions and trial status
Back in February 2024, the Council of the Eurasian Economic Commission revised the clinical and clinical laboratory study rules under medical device registration, which entered into force in July 2024.
Key updates of the new EAEU rules:
▪ New criteria for equivalence assessment for validation of clinical study results;
▪ Refined trial parameters and conditions for in vitro diagnostic devices and medical software;
▪ Clarified requirements for clinical trial approval, plus grounds for removing medical institutions from the list of eligible trial sites.
Note: The new EAEU regulation does not apply to medical device registration applications submitted before its entry into force, where clinical study agreements have already been signed. Such projects may proceed under the previous rules.
