Certificates
Europe
CE
ISO 13485:2016
South Korea
KFDA
Certificate of Manufacturer
– Ministry of Food and Drug Safety (MFDS)
Certificate of GMP
– Seoul Regional Food and Drug Administration, Koreas Testing Laboratory
USA
US FDA 510K
– U.S. Food and Drug Administration
Taiwan
Ministry of Health and Welfare Medical Device (QSD) Certificate
– Taiwan Food and Drug Administration
Singapore
Singapore Medical Device Register (SMDR)
– Health Science Authority
Ukraine
Medical Device Registration Certificate (UkrCEPRO) of Ukraine
– Ministry of Health of Ukraine
India
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)
Others