Entry in the register of specialised stores who perform retail trading in medical devices

Opticians as producers and retailers in specialized stores with medical devices:

Correction glasses are a medical device. In accordance with the Act on medical devices and the Rules on the manufacturing and trade with medical devices the business entities performing the production or trading with medical devices, must fulfil relevant conditions and the demands of the provisions from the mentioned regulations related to the activities of production or trading and they must be entered in the register at the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (JAZMP). 

If opticians have an ophthalmology clinic (medical practice) the conditions stipulated by the health legislation must be fulfilled (it is not a craft activity).

Supporting evidence

 

Last updated: 12. 04. 2016