Medical Device Registration Services - Korea

Regulatory Department

The Ministry of Food and Drug Safety (MFDS)

Regulation

  • Medical Device Act, Law No.6909, 2003

  • Act on In Vitro Diagnostic Medical Devices, Law No. 16433, Enactment: Apr. 30, 2019

Recognised Quality Management System

Korean Good Manufacturing Practice (KGMP)

Regulatory Classification & Registration Process

Class I – Lowest Risk

  • Compliant with KGMP

  • Pre-Market notification and approval required

  • Timeframe: 1-2 months

Class II

  • KGMP Certification

  • Pre-Market notification and approval required

  • Certification of validity of equivalent medical devices

  • Timeframe: 1-6 months

Class III

  • KGMP Certification

  • Pre-Market notification and approval required

  • Technical Files Review

  • Clinical Reports

  • Timeframe: 7-9 months

Class IV – Highest Risk

  • KGMP Certification

  • Pre-Market notification and approval required

  • Technical Files Review

  • Clinical Reports

  • Timeframe: 7-9 months

* A Korean In-Country Caretaker is required to represent overseas medical device manufacturers. We will be able to manage this for you.

Looking to register your medical device in Canada? Contact us today!