Group 325

Manufacture of medical and dental devices

This category includes the manufacture of equipment and instruments used in diagnosis, treatment and dentistry, including medical furniture and prostheses. Essentially, it covers manufacturers of medical and dental devices that do not fall into the category of medicines or textile consumables.

Included Activities & Applicability

  • Manufacture of medical instruments and appliances
  • Manufacture of medical laboratory apparatus
  • Manufacture of special medical furniture
  • Manufacture of dental equipment
  • Manufacture of prostheses and orthoses

Excluded Activities & Restrictions

  • Manufacture of medicines and pharmaceutical products
  • Manufacture of medical gloves
  • Manufacture of medical textile products
  • Manufacture of sterile packaging for medical devices

Detailed Analysis & Commercial Insights

Manufacture of Medical and Dental Devices (CAEN Code 325)

The medical and dental device manufacturing industry, represented by CAEN code 325, is an essential pillar of the healthcare system in Romania. It includes the production of surgical instruments, diagnostic equipment, dental equipment, as well as specialized furniture for medical offices. The sector has seen significant evolution in recent years, driven by increased investment in healthcare and demand for modern technologies. From a macroeconomic perspective, this niche contributes to reducing import dependency and creating highly skilled jobs. The main challenges for entrepreneurs in this field include complying with strict quality and certification standards (such as ISO 13485), high research and development costs, and strong competition from international manufacturers. However, opportunities are substantial, especially in the context of the digitalization of medical services and the growing demand for minimally invasive and personalized devices, such as dental prostheses made by 3D printing. To succeed, entrepreneurs must access European funds for innovation and collaborate with universities and hospitals to test and implement new products.