Understanding Medical Device Registration in South Korea
Updated on: 23/01/2024
Regulatory Authority: The Ministry of Food and Drug Safety (MFDS)
The Korea Medical Devices Industry Association (KMDIA), the largest association of over 900 medical devices companies, aims to improve public health and boost industry growth by partnering with its members to lead technological advances in the 21st century.
Link for Regulatory Authority: https://www.mfds.go.kr/eng/index.do
Local Regulation: Medical Device Act (MDA)
Classification:
Overview of Notification, Certification and Approval Process in Medical Devices
MFDS requires the submission of ‘Technical Documents’ for the certification and approval of medical devices.
In principle, Class I & II devices are certified by Medical Device Information and Technology Assistance Center (MDITAC) the National Institute of Medical Device Safety Information (NIDS) and Class III & IV devices are approved by MFDS. However, Class I & II devices in the categories below must be approved by MFDS.
Listing or Registration Requirements:
Documents Required:
The technical documents consist of ‘Application Form’ and ‘Supplementary Evidence.’ The presence of mandatory submission of ‘clinical trial reports’ (as a part of ‘Supplementary Evidence’) determines application procedure to be followed.
If a device is substantially equivalent to legally marketed devices, ‘clinical trial reports’ are not required.
Premarket Approval Process:
Class I Approval Process: Notification
Class II Approval Process: Certification
Class II, III and IV Approval Process: Approval
Certification of Class II Medical Devices
Approval of Class II, III and IV Medical Deivces
NIFDS (affiliated agency of MFDS) approves ‘New devices (Class II)’ and ‘Class III and IV Devices’
Class II, III and IV devices must submit:
Registration Timeline:
Registration Fee:
SER- (registered predicate or Substantial Equivalent (S.E.) exists in Korea.)
License Validity and Renewal: Medical device registration licenses do not expire, but the KGMP Certificate must be renewed every three years.
Special Labelling Requirements: Label and instructions for use must be provided in Korean
Additional Comments: All application files must be available in Korean language
Who should make this communication:
When to make this communication: Before placing a medical device into the market.
How OMC Medical can assist you with the process
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.