Roszdravnadzor Order No. 662 of July 22, 2026, was published, approving new checklist forms for assessing compliance with mandatory requirements at all stages of medical device circulation. This document repeals previously effective Orders No. 1 of January 10, 2022, and No. 5169 of September 17, 2025.
What’s updated
– Seven forms of checklists; cover the full cycle: technical and toxicological testing, clinical studies, installation, repair, transportation, storage, and retail sales.
– References to regulatory legal acts have been updated; references to Ministry of Health orders and Eurasian Economic Commission decisions have been updated in all forms, and references to obsolete documents have been removed.
– The number of questions has been reduced:
– clinical trials – from 15 to 13;
– use in medical organizations – from 16 to 12;
– maintenance and transportation – from 7 to 6.
Key changes in wording
A question about the possibility of documenting conformity assessment results on paper or as an electronic document has been added to the checklist for technical and toxicological testing. The requirement to check whether a medical organization has a list of clinical trials has been removed.
Significance for market participants
– Digitalization of control: the admissibility of electronic documents has been established, which reduces the workload on laboratories.
– Warehouse and logistics: increased control over storage and transportation conditions, reducing the risk of products with improper storage conditions or counterfeit products entering circulation.
– Service and maintenance: inspectors will check the regularity of equipment maintenance directly at medical organizations .
– Retail: the list of questions for checking pharmacies and distributors has been clarified.
– Predictability of inspections: the abbreviated structure of checklists reduces the risk of arbitrary interpretation of requirements by inspectors.
Harmonization with the EAEU
The update was implemented taking into account the requirements of the legislation of the Eurasian Economic Union, which brings Russian oversight practices closer to the uniform standards of the EAEU member states and ensures the unification of requirements for medical devices throughout the Union.
