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Market Information
South Korea’s healthcare expenditure is $4570 per capita on health, similar to the OECD average of $4986 (USD PPP). This is equal to 9.7% of GDP, compared to 9.2% on average in the OECD.
Market Trend: All Singaporeans have basic medical insurance in the form of MediShield Life. Another 69% have the Integrated Plan on top of the basic insurance.
South Korea’s medical equipment market is expected to reach US$7.09bn in 2024.
Korea Food and Drug Safety, along with its six regional offices, was founded in April 1996 and later elevated to administration status as the Korea Food & Drug Administration in 1998. In 2004, the organization underwent restructuring, leading to the establishment of the Medical Devices Management Division and Bioproduct Technical Support Division. In March 2013, it underwent another restructuring, achieving ministry status and undergoing a name change.
Medical Device Regulation
The Korean Ministry of Food and Drug Safety (MFDS), under the MOH.
Classification, Fees, Timeline
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Product Registration Routes
Class I
Registration
Class II
Certification
Class III and Class IV
Approval from MFDS
Useful Information
Validity of License: No expiry, KGMP certificate has to be renewed every three years.
License transfer: The former license holder is required to transfer all rights and responsibilities to the new license holder.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
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