Medical devices

The applicant assuming performance of works (rendering of services) in accordance with Annex № 1 to the Rules of submission of notifications of initiation of individual types of entrepreneurial activities and accounting of these notifications, approved by the decree of the Government of the Russian Federation dated 16.07.2009 № 584 "About a notifying order of the commencement of certain types of entrepreneurial activities" (hereinafter – the Rules) provides Notification of the commencement of activities in the sphere of medical devices circulation (hereinafter – Notification) to the Federal Service for Surveillance in Healthcare at the address: 109074, Moscow, Slavyanskaya square, 4, building 1.

The Notification shall be made in accordance with Annex 2 of the Rules and shall be submitted in duplicate.

The type of activity, types of works (services) are specified according to point 87 of the List of works and services as a part of separate types of business activity according to Appendix No. 1 of Rules, namely: "Technical tests, toxicological researches, production, import to the territory of the Russian Federation, export from the territory of the Russian Federation, storage, transportation, realization, utilization, destruction".

Registration of the Notification is carried out in the day of their receipt by Roszdravnadzor.

Placement of the data from the registered Notifications on the official site of Roszdravnadzor is performed within 10 days from the date of registration of the Notification.

Data on changes are submitted to authorized authority within 10 days from the date of introduction of the corresponding changes by means of submission (direction) of the statement in any form to authorized authority with Appendix of copies of the documents confirming the fact of introduction of the corresponding changes, or as an electronic document signed by the strengthened qualified electronic signature of the applicant.