Roszdravnadzor to Share Authority for Licensing Medical Equipment Services with Regions

Changes are planned to be made to the Regulation on licensing activities for the maintenance of medical devices, approved by RF Government Resolution No. 2129 of November 30, 2021.

The new regulations envisage a redistribution of powers. The head Roszdravnadzor will retain the right to issue licenses, provide extracts from the register, suspend, renew, terminate licenses, and cancel them. In addition, it will continue to assess the applicant's compliance with licensing requirements in relation to those applicants who have provided it with documents.

Territorial bodies will receive powers to make changes to the register of licenses and assess the licensee’s compliance with licensing requirements in relation to licensees who have submitted applications for making changes to the register of licenses through territorial bodies.

The amendments were developed with the aim of "implementing client-centricity" in the activities of Roszdravnadzor, as well as to comply with the deadlines for the provision of the state service for licensing the activities of the medical equipment service. The authors of the amendments expect that the new regulations will improve its accessibility, territorial affiliation, as well as satisfaction of applicants with the quality of the service provided for licensing the service.

In November 2021, the Russian Government approved a new regulation on licensing the maintenance of medical devices. Low-risk medical device maintenance, as well as legal entities or individual entrepreneurs servicing their own medical equipment, were exempted from regulation. In addition, the new version of the regulation specifies a list of equipment required for servicing medical equipment for each type. Companies engaged in the maintenance of medical equipment had to submit an application to Roszdravnadzor by January 1, 2024, to amend the register in connection with the updating of the list of maintenance work performed.