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全球 > 亚洲 >
South Korea
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市场信息
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.
医疗器械监管
The Korean Ministry of Food and Drug Safety (MFDS), under the MOH.
分类、费用、时间表
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产品注册途径
Class I
Registration
Class II
Certification
Class III and Class IV
Approval from MFDS
有用信息
许可证有效性：无有效期，KGMP 证书需每三年更新一次。
许可证转让：原许可证持有人需将所有权利和责任转移给新许可证持有人。
进口商和分销商：当地许可证持有人代表产品所有者负责任命进口商和分销商。
