Manufacture of medical and dental instruments and supplies (32.500)

• Act on Medical Devices

Before they begin performing their activities, legal or natural entities registered in the Republic of Slovenia for performing activities related to the manufacture of medical devices, wholesale and retail sale of medical devices must be entered into the register of manufacturers and suppliers of medical devices at the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices or into the register of medical devices that may be sold in the Republic of Slovenia.

A legal or natural entity dealing with retail trade in medical supplies in a specialised shop must, in addition to general conditions, also meet special conditions set forth by the competent minister in agreement with the minister competent for trade.

Source: Ministry of Infrastructure

• List of activities usually carried out as a craft

  For activities listed on the List of activities usually carried out as a craft, business entities registering these activities must also enter in the register of crafts at the Chamber of Craft and Small Business of Slovenia (OZS) ex officio.

  Applicable for the following activities/services:

  • the manufacture of orthopaedic and prosthetic appliances:
  • crutches, orthopaedic belts and suspenders, splints,
  • artificial ligaments and other artificial body parts,
  • orthopaedic footwear
  • manufacture of medical thermometers
  • manufacture of glass lenses, contact lenses, protective glasses and sunglasses as well as corrective glasses
  • manufacture of medical, dental and veterinary furniture, operating tables, hospital beds with mechanical accessories, dental engines with mechanical accessories
  • repairs and maintenance of products from this subclass

  Source: Ministry of Economic Development and Technology

• the manufacture of instruments and devices for the needs of medicine, surgery, dental medicine and veterinary medicine;
• manufacture of dental fillers and cement and similar dental materials;
• manufacture of cement for bones;
• manufacture of ovens for laboratories (including for dental purposes);
• manufacture of laboratory sterilisers, distillation devices, centrifuges, etc..;
• manufacture of syringes, medical needles, catheters, cannulae, mirrors, plates and ligaments for bones etc.;
• manufacture of surgical compresses and sterile surgical threads;
• manufacture of dental instruments;
• manufacture of artificial teeth, dental bridges and dentures;
• manufacture of mechanical therapeutic devices, massage devices, devices for psychological testing, for ozone therapy, for oxygen therapy, for artificial ventilation;
• manufacture of orthopaedic and prosthetic devices:
• crutches, orthopaedic belts and suspenders, splints, artificial ligaments and other artificial body parts, orthopaedic footwear;
• manufacture of medical thermometers
• manufacture of glass lenses, contact lenses, protective glasses and sunglasses as well as corrective glasses;
• manufacture of artificial eyes;

This includes:

• manufacture of medical, dental and veterinary furniture, operating tables, hospital beds with mechanical accessories, dental engines with mechanical accessories;
• repairs and maintenance of products from this subclass;

Source: Statistical Office of the Republic of Slovenia – Explanatory notes to the standard classification of activities – SKD 2008.pdf (1.8 MB)

This includes:

• The filling of medical devices – breathing apparatuses with oxygen;
• Dental laboratories – services;
• Spring locks -– elements for denture insertion;
• Artificial teeth (ceramic, porcelain) - manufacture;   
• Urine and blood bag assembly;
• Maintaining medical apparatuses;

Source: Statistical Office of the Republic of Slovenia – Questions and answers table