On the entry into force of the new administrative regulation of Roszdravnadzor
The Federal Service for Supervision of Healthcare informs that from August 9, 2019, Roszdravnadzor Order No. 3239 of April 25, 2019, “On Approving the Administrative Regulations of the Federal Service for Supervision of Healthcare on the provision of public services for the reception and recording of notifications of implementation activities in the field of circulation of medical devices (with the exception of conducting clinical trials of medical devices, their production, installation, commissioning, use, operation, including technical maintenance, as well as repair) ”(registered with the Ministry of Justice of Russia on July 26, 2019 No. 55419).
The introduction of this order is aimed at harmonizing the provisions of the regulation for the provision of this service for receiving and recording notifications of the start of activities in the field of circulation of medical devices (with the exception of clinical trials of medical devices, their production, installation, commissioning, use, operation, including maintenance, as well as repair) with the requirements specified in the Submission Rules for notifications about the beginning of certain types of entrepreneurial activities and the accounting of these notifications approved by the Government of the Russian Federation on July 16, 2009 No. 584.
Please note that in connection with the amendments that have entered into force, the applicant has the right to file a notice on the start of entrepreneurial activity in the field of circulation medical devices to any territorial authority of Roszdravnadzor of their choice.