Montenegro – Wholesaler Registration Guideline

PURPOSE

The purpose of this document is to provide orientation to the industry professionals regarding regulatory requirements for registration of medical devices wholesalers in Montenegro. The information provided is based on applicable laws and ordinances and some in particular have been clarified with officials of national bodies, where needed.

The guideline has been also created for purpose of providing summary of regulatory information at single location in order to save time and effort of its users, in preliminary investigation of national regulatory framework for medical devices.

Regulamedica® is a consulting service for “unknown user” and does not act on behalf of any National Agency, therefore formal requirements concerning registration of medical device wholesalers are only provided by relevant national authority sources of information.

SCOPE

The document provides regulatory information for registration of medical device wholesalers at National Agency of Montenegro, for the purpose of medical device wholesale and placement to market of Montenegro. The Guideline is applicable to medical devices wholesalers only.

OTHER

Guidelines are continuously accessible online thru Regulamedica® user panel, also mobile compatible.