The Ministry of Health will expand the risk categories for medical device inspections.

According to the draft, Roszdravnadzor must conduct an inspection visit, on-site inspection, test purchase, or random inspection for high- risk categories once every two years.

If the resolution is approved, the preventive visit, as well as other supervisory activities, will be conducted not only in the form of a preventive conversation at the place of business or by video conferencing, but also using the Inspector mobile app.

For regulated entities that have submitted notification of the commencement of certain types of business activities (technical testing, toxicological testing, manufacturing, storage, transportation, sale, disposal, and other activities), Roszdravnadzor may conduct a mandatory preventive visit no later than six months from the date of notification. For high-risk categories, this visit may be conducted once a year. Upon completion of this visit, a special report will be prepared in duplicate.

The Ministry of Health proposed removing from the resolution the clause that allows a monitored individual to refuse a mandatory preventive visit by notifying the state oversight body no later than three business days before the visit. The regulator also proposed eliminating the use of audio recording during inspections.

In addition, the resolution is planned to be supplemented with a clause stating that inspection, questioning, and examination may be carried out using remote interaction tools.

Complaints about the actions (or inactions) of Roszdravnadzor will be reviewed by the Ministry of Health. Regulated entities whose rights and legitimate interests they believe were violated during state oversight have the right to file a pre-trial appeal. The complaint will be reviewed within 15 business days from the date of its registration. The current subject-matter document stipulates a maximum of 20 business days for complaint review. Complaints about the decision to classify controlled entities into the relevant risk category will be reviewed within five business days.

According to the draft, the classification of a state-controlled object as a high-risk category will be carried out in connection with the production and/or manufacture of medical devices and the conduct of clinical trials of medical devices.

In March 2025, it was reported that Roszdravnadzor had conducted 559 unscheduled inspections of medical devices over the previous year. As a result, the regulator conducted 3,008 control actions. The total amount of administrative fines imposed amounted to 60 million rubles.