Medical Device & Pharmaceutical Regulatory Consulting in South Korea | GRP

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Medical Device and Pharmaceuticals Regulatory Affairs and Quality Consulting for South Korea

South Korea Regulatory Affairs

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South Korea’s healthcare market is ranked fourth among countries in the Asia-Pacific region. The combination of increased insurance coverage, an aging population, and government initiatives to expand the healthcare market make South Korea a prime destination for foreign medical companies looking to go abroad. GRP team can help your medical device company access the Korean medical market by registering successfully your products in Korea.

South Korea Medical Device Market Size South Korea Pharmaceutical Market Size
 $5.5 billion $22 billion
Projected Growth Rate: 5.3% Projected Growth Rate: 4%
South Korea Economic Indicators
GDP (PPP): $1.8 trillion
Per Capita GDP (PPP): $36,500
Real GDP Growth Rate: 2.7%
Population (millions): 50.5
Ethnic Diversity: 92% Very Homogenous


The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food & Drug Administration (KFDA), oversees the safety and efficacy of drugs and medical devices in Korea.

The MFDS is divided into five bureaus. The Pharmaceutical Safety Bureau and the Medical Device Safety Bureau are the two divisions holding primary responsibility for pharmaceutical and medical device regulations. For more information check MFDS (KFDA) website at: