Medical devices

Counter of appeals of citizens and organizations

NOTIFICATION OF COMMENCEMENT OF ACTIVITIES IN THE SPHERE OF MEDICAL DEVICES CIRCULATION

Submission of Notification on the commencement of activities in the field of medical devices circulation (except for clinical trials of medical devices, their production, installation, commissioning, use, operation, including maintenance and repair)

In accordance with article 8 of the Federal Law of 26.12.2008 № 294-FZ "On protection of the rights of legal entities and individual entrepreneurs in the implementation of state control (supervision) and municipal control" legal entities, individual entrepreneurs are obliged to notify the commencement of the implementation of certain types of business activities authorized in the relevant field of activity authority (authoriries) of state control (supervision) (hereinafter in this article - the authorized authority of state control (supervision).

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.

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Making changes to the registry entry

A legal entity or an individual entrepreneur is obliged to inform the authorized authority that registered the Notification about the following changes:

a) change in the location of the legal entity and (or) the place of actual activity;

b) change of the place of residence of an individual entrepreneur and (or) the place of actual activity;

c) reorganization of a legal entity.

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.

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