Overview

In order to enter the Slovakian Medicinal Products and Medical Devices market, foreign manufacturers must need an authorized representative from anywhere in the EU region. Manufacturers must notify the State Institute for Drug Control (SUKL) to get the market access. With the growing requirement for sophisticated health technologies and equipment in the region, Slovakia offers excellent market opportunities for foreign manufacturers. However, navigating the improved market authorization procedures might pose a great challenge for foreign manufacturers while entering the region.

With extensive knowledge on European medical device regulations, Freyr as a global partner assists manufacturers to enter the market with ease while managing respective Regulatory technical filings, registration procedures, obtaining licenses, and risk management of inactive medical devices. Freyr's end-to-end Regulatory Affairs consulting for Slovakia span across:

  • Medical Devices
  • Drugs
  • Food Supplements
  • OTC

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • CE Marking

Freyr Advantages

  • Strategic local Health Authority contacts
  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines