According to industry experts, the medical device market in Croatia was valued at $268 million in 2016. The market demonstrates solid growth and is expected to reach $294 million in 2017. The largest product categories are consumables (24% of the total market) followed by patient aids, dental products and orthopaedics. Imports account for around 90% of the medical device supplies.

To facilitate the distribution practices for medical devices, the Croatian Agency for Medicinal Products and Medical Devices (HALMED) is organising an educational course “Distribution and good practice in medical device distribution”.  The course is intended to wholesalers of medical devices and authorised manufacturer’s representatives from the third countries.

The course will aim to address the following key topics:

  1. Introduction – The Medical Devices Act within the context of the EU regulatory framework
  2. Placing medicinal products on the Croatian market
  • medical devices generally: definition, classification, essential requirements;
  • stakeholders;
  • medical device manufacturer’s registry – procedure and documentation;
  • medical device registry – procedure and documentation;
  • notification on placing medical device on the market – notification procedure and documentation;
  • practical exercise: filling out of OČ-PR, OČ-MEDPRO-I, MEDPRO-II/III.
  1. Good distribution practice of medical devices
  • novelties in laws and bylaws
  • medical device wholesalers registry – procedure and documentation
  • good distribution practice of medical devices
  • writing of standard operative procedures – basic principles
  • practical exercise – filling out of OČ-VELE form, writing SOPs.

For further information regarding regulatory submissions, MA approval and national authorisation procedures in Central and Eastern Europe, please contact Jane Smith at Grove Group Pharmaservices  or visit our website