South Korea has a progressive healthcare system. To cater to the improved and continued monitoring, and diagnosis of health, South Korea imports major portion of its medical devices. Marketing approval from local Medical Device authority, Medical Device Information & Technology Centre (MDITAC), which functions under the scope of Ministry of Food and Drug Safety (MFDS) is mandatory to enter the Medical Devices South Korean market.

While entering the South Korean market, unanticipated Regulatory challenges can turn out to be potential roadblocks. With a strong regional presence in South Korea, Freyr addresses market-entry challenges like device classification, technical documentation, local language translations, local representation, etc. Freyr also assists foreign manufacturers in procuring clinical testing support. Our experts can handle Quality Management System (QMS) compliance to establish product quality, safety and efficacy. Freyr’s Medical Device Regulatory services in South Korea extends to the following device types:

  • Medical Devices (Class – I, II, III & IV)
  • In-vitro Diagnostic Devices
  • Combination Products
  • New Devices (Novel devices)

South Korea Market Entry for Medical Devices - Process Flow

South Korea Market Entry Strategy - Medical Devices Registration


Freyr Expertise

  • Medical Device Registration and Approval
  • Quality Management System (QMS) Compliance
  • South Korea License Holder Representation Services
  • Medical Device Regulatory Strategy Report
  • Classification of Medical Device
  • Local Clinical Testing Support
  • Labeling and GMP Support
  • Post-market Monitoring and Adverse Event Reporting

Freyr Advantages

  • Strategic and well-versed local Regulatory knowledgebase – with 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