CE

ISO 13485:2016

 

KFDA

Certificate of Manufacturer

– Ministry of Food and Drug Safety (MFDS)

Certificate of GMP

– Seoul Regional Food and Drug Administration, Koreas Testing Laboratory

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US FDA 510K

– U.S. Food and Drug Administration

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Ministry of Health and Welfare Medical Device (QSD) Certificate

– Taiwan Food and Drug Administration

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Singapore Medical Device Register (SMDR)

– Health Science Authority

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Medical Device Registration Certificate (UkrCEPRO) of Ukraine

– Ministry of Health of Ukraine

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Registration certificate to be issued for import of devices into India under drugs and cosmetics rules 1945

– Government of India (Central Drugs Standard Control Organisation Ministry of Health & Family Welfare)