Overview

Being one of the advanced markets for Medical Devices enabled with high-tech functionalities and with majority of the population opting for high standard medicinal products, South Korea attracts Medical Devices, medicinal products and cosmetics manufacturers from all over the world. To access the market, manufacturers must obtain authorizations from the Korean Food and Drug Administration (KFDA). Though the market seems lucrative and provides enormous growth opportunities, the region’s increasingly strict regulations might challenge manufacturer’s compliance efforts for medical device registrations and cosmetics registrations.

With the best of understanding on critical registration and licensing processes in South Korea, Freyr assists new market entrants, Device and Cosmetic manufacturers, to avail the maximum of opportunities by streamlining the processes enroute getting the Ministry of Food and Drug Safety (MFDS), formerly known as KFDA, approvals. Freyr’s end-to-end Regulatory Affairs consulting services for South Korea span across:

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Market Authorizations
  • Regulatory Submissions
  • Cosmetic Labeling requirements
  • Ingredient review
  • Cosmetics Claims Substantiation
  • Local Agent assistance

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with KFDA and MFDS
  • Team with 25+ years of strong foothold in the region
  • Proven track record for device registrations and submissions
  • End-to-end Regulatory consultation
  • Structured and cost-effective approach to ensure speed to market
Global HA Mandates
 
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