MFDS

Ministry of Food and Drug Safety

MFDS 🇰🇷 South Korea National Active
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About

MFDS regulates medical devices in South Korea under the Medical Devices Act. It operates the Korean Good Manufacturing Practice (KGMP) system and participates in MDSAP.

Regulatory Details

Regulatory FrameworkMedical Devices Act
Device ClassificationClass I, Class II, Class III, Class IV
Jurisdiction TypeNational
Country🇰🇷 South Korea
StatusActive

Online Resources

Contact Information

Country🇰🇷 South Korea
AddressOsong Health Technology Administration Complex, 187 Osongsaengmyeong 2-ro, Cheongju, Chungcheongbuk-do 28159, South Korea
Phone+82-43-719-1564

Official Website

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