The Russian Ministry of Health has submitted for public discussion a draft resolution providing for significant changes to the Regulation on Roszdravnadzor (approved by Russian Government Resolution No. 323 of June 30, 2004). The document, which is being discussed until July 16, aims to harmonize Russian regulations with EAEU standards and consolidate digital mechanisms in oversight activities.
Key innovations in the department’s powers
1. Import of samples for registration: permission is replaced by notification
Instead of issuing import permits for medical devices for state registration, Roszdravnadzor will accept and consider notifications of such intent (paragraph 5.1.2.2 in the new version). The administrative barrier will be transformed into a registration procedure, which is consistent with the notification principles enshrined in EAEU law. For applicants, this means an accelerated start to registration trials and reduced costs.
2. Clinical trials: focus on expertise
Subclause 5.55 clarifies the distinction between clinical trials and clinical laboratory trials (including interventional efficacy studies). Permits are issued strictly in accordance with the Rules approved by EEC Council Decision No. 29 of February 12, 2016 (as amended by Decision No. 7 of January 26, 2024). The Service organizes the review of applications and documents, entrusting the review to expert organizations.
3. Unified register of permits and notifications
Roszdravnadzor is required to enter data into the register of issued permits and submitted notifications for clinical (clinical and laboratory) trials (subparagraph 5.5[10]). A public digital profile of all trials conducted in the country is being created, increasing transparency and enabling the tracking of the status of developments, including combination products.
4. Notifications about the start of activities: information via widget
Previously, the agency independently accepted and processed notifications regarding the commencement of activities in the field of medical device circulation (except for clinical trials, manufacturing, installation, etc.). Now, this function is limited to posting a widget on the official website displaying data from the Unified Register of Notifications (a subsystem of the Federal State Information System). This is a step toward automated notification.
Result of changes
For the regulator, this means expanding its oversight capabilities without introducing new mandatory requirements for businesses (according to the explanatory note). However, expanding the scope of oversight creates additional grounds for inspections—from documentary inspections to on-site and test purchases.
For manufacturers and marketing authorization holders, the registration process is simplified through a notification procedure, but strict adherence to procedures is essential. Maintaining registries increases transparency but requires timely notification by market participants.
The draft resolution is not a technical amendment, but a systemic expansion of Roszdravnadzor’s oversight functions, accompanied by the digitalization of accounting procedures. For the market, this signals a shift toward more formalized, transparent, and rigorous risk-based oversight at all stages—from sample import to clinical trials and the daily use of medical devices .
