South Korea Revises Medical Device Regulations

South Korea’s Ministry of Food and Drug Safety (MFDS) has made three significant amendments to the country’s Medical Devices Act that will affect some market registrants going forward.

First, MFDS has introduced Summary Technical Documentation (STED) requirements for Class IV medical device registrants. Registrants with Class I, II and III devices may voluntarily submit application materials in STED format. Mandatory STED submissions for Class IV device applicants will become effective in January 2014.

MFDS medical device regulation changes in KoreaSecond, new electronic safety compliance standards incorporating IEC 60601-1 3rd Edition will be phased in for medical device registrants in South Korea over the next several years. Class III and IV devices must comply with the new safety standards starting in June 2014; Class II devices will have until June 2015, and Class I devices will have a June 2016 compliance deadline.

Third, MFDS has announced several changes to its classification and grades regulations:

  • More than 90 products have been added to the “cell manipulating kit for medical use” category
  • Definitions have been changed for 108 devices
  • “Dental color measuring” devices have been down-classified from Class II to Class I

Manufacturers with medical device registrations in South Korea should examine the MFDS amendments with their Korea Third Party License Holders to determine how and when their registrations will be affected.

Stewart Eisenhart