The following entities are entered into the register of legal entities wholesaling medical devices:
- legal entities with a registered office inthe Republic of Slovenia, wholesaling medical devices,
- importers of medical devices with a registered office in the Republic of Slovenia,
Legal entities entered into the aforementioned register must meet the provisions of the medical Products Act (Official Gazette of the Republic of Slovenia, No. 98/09) and Rules on manufacturing and marketing medical devices (Official Gazette of the Republic of Slovenia, No. 37/10).
Wholesale of medical devices shall mean purchasing of medical devices and selling them to legal entities which buy them to perform their profession or registered activity.
Import of medical devices for wholesale shall mean wholesale of medical devices from third countries into the territory of the European Union. Legal entities wholesaling medical devices may import only medical devices for which the manufacturer of medical devices from third countries have an authorised representative with a registered office in the European Union.
PROCEDURE OF ENTRY, AMENDMENT AND DELETION FROM THE REGISTER OF LEGAL ENTITIES WHOLESALING MEDICAL DEVICES
Entry into the register is performed on the basis of an application of the applicant, which may be filed on the proposed application forms within 15 days of taking up the activity.
Entering an amendment into the register is performed on the basis of an application of the applicant, which may be filed on the proposed application forms within 15 days from the day of the amendment entering into force.
Deletion from the register is performed on the basis of a written request of the applicant, which must include the act of authority for operation of the legal entity or any other document which presents termination of operation of the appropriate activity or termination of operation of the legal entity.
COSTS OF THE PROCEDURE
Costs of the procedure of entry, amendment or deletion from the register of legal entities wholesaling medical devices in accordance with the Administrative Fees Act (Official Gazette of the Republic of Slovenia, No. 106/2010 – official consolidated text, 14/15 – ZUUJFO, 84/15 – ZZeIP-J IN 32/16) amount to 4.50 EUR and must be transferred to the following account
Invoice No.: 01100-1000315637, reference number: 11 27650-7111002 with the beneficiary of the payment: Administrative fee – national Ljubljana (mandatory!)
Receipt against payment must be included in the application as proof
For notifying the entry, amendment of information or deletion from the aforementioned register, please complete the following forms and annexes:
- FORM B – Entry into the register of legal entities wholesaling medical devices
- ANNEX 2 – Classification of medical devices
- ANNEX 3 – List of manufacturers
If you need the confirmation of entry, please also complete the form below. Confirmations of entry are not issued ex officio, but only at the request of the client.
- Application for a certificate of registration in the register of activities involving medical devices
With the application for the certificate, a confirmation of existing current entry is obtained. The certificate is issued at the request of the applicant within 15 days from receiving the claim and is free of charge.