Slovenia – Manufacturer Registration Guideline

PURPOSE

The purpose of this document is to provide orientation to the industry professionals regarding regulatory requirements for registration of medical devices manufacturers in Slovenia. 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 device manufacturers.

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 manufacturer are only provided by relevant national authority sources of information.

SCOPE

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

OTHER

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