Overview
South Korea is one of the biggest markets for health care in the Asia-Pacific region. The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), is the Regulatory body that regulates Medical Devices in South Korea. Current Korea Medical Device regulations are covered under the Medical Device Act (MDA) 2015. Marketing approval from the local Medical Device authority, Medical Device Information & Technology Centre (MDITAC), which functions under the scope of the MFDS is mandatory to enter the South Korean Medical Devices market.
Medical Device Classification
South Korea Medical Device Classification
As per the MFDS Notification No. 2016-4, in South Korea, devices are classified into Class I, II, III, and IV depending on their risk level. Class I devices have little risk to patients, while Class IV devices are high-risk, complex devices. The Class I and some Class II devices require certification by the MDITAC, while new Class II devices, Class III, and Class IV devices require approval by the MFDS.
|
Class |
Registration Pathway |
|
Class I Devices |
Notification by MIDTAC |
|
Class II Devices |
Certification by MIDTAC+ Approval by NIFDS |
|
Class III Devices |
|
|
Class IV Devices |
We at Freyr South Korea, help you identify the appropriate category, respective Regulatory approval process, and overall Medical Device Regulatory support in South Korea.
South Korea Medical Device Registration
KGMP Certification: The manufacturer and Korea License Holder must comply with Korea Good Manufacturing Practice (KGMP) quality system requirements. The KGMP certification includes an on-site audit of foreign manufacturing facilities. The KGMP certificate is issued by the MFDS and is valid for three (03) years. The certification is required before the product registration.
Device Registration
The device registration procedure varies with the class of device.
Class I Medical Devices: Most Class I Medical Devices are exempted from the technical review and KGMP certification procedures, and they require a Pre-Market notification to market the device. The manufacturer shall provide basic information about the device and apply for approval. The registration of the Class I device will be completed after uploading registration information on the MFDS portal.
Class II, III, and IV devices: The manufacturer of Class II, III, and IV devices shall obtain pre-market approval, and the registration does not expire. The devices can obtain approval from the MFDS through any one of the following two review options:
- General Technical File Review
- Technical Safety & Efficacy Review (SER)
Clinical study reports are not required for General Technical File Review but are an essential requirement for Technical SER. For classes other than Class I, the General Technical File or SER Technical File is reviewed by the MFDS.
Important Validities
Device approvals do not expire in South Korea. Freyr South Korea supports you with the post-approval life cycle management of your product and with overall Medical Device Regulatory affairs in South Korea.
Freyr Expertise
- Regulatory Due Diligence
- Device Registration
- Submission Management to MFDS or Notified Bodies
- Data Reliability Inspection
- QMS Inspection
- Reimbursement Application Submission
- Labeling Support
- Distributor Identification and Qualification
