Changes to the Russian Regulation of Medical Devices Come into Force

On August 9, 2019, Roszdravnadzor’s order No. 3239 from April 25, 2019 “On approval of the administrative regulations of the Federal Service for Supervision of Health Care for the provision of public services for receiving and recording notifications of the start of activities in the field of circulation of medical devices” came into force.

The introduction of this order is aimed at harmonizing the regulations for the provision of the specified service for receiving and recording notifications about the start of activities in the field of circulation of medical devices with the requirements specified in the Rules for the submission of notifications on the commencement of certain types of entrepreneurial activities, approved by Resolution of the Russian Government ¹ 584.

In connection with the changes that have entered into force, the applicant has the right to file a notice of the start of entrepreneurial activity in the field of the circulation of medical devices to any territorial body of Roszdravnadzor of his choice.

Source