info@wiselink.com.au
1300 76 80 90
Medical Device Registration Services - Korea
Regulatory Department
The Ministry of Food and Drug Safety (MFDS)
Regulation
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Medical Device Act, Law No.6909, 2003
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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
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Compliant with KGMP
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Pre-Market notification and approval required
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Timeframe: 1-2 months
Class II
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KGMP Certification
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Pre-Market notification and approval required
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Certification of validity of equivalent medical devices
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Timeframe: 1-6 months
Class III
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KGMP Certification
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Pre-Market notification and approval required
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Technical Files Review
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Clinical Reports
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Timeframe: 7-9 months
Class IV – Highest Risk
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KGMP Certification
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Pre-Market notification and approval required
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Technical Files Review
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Clinical Reports
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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.
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Looking to register your medical device in Canada? Contact us today!
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