[KOREA] MFDS Medical Device Certification
■ Certification Overview In Korea, medical devices are regulated by the Ministry of Food and Drug Safety (MFDS). The legal […]
▪ ASIA
[CHINA] NMPA Medical Device Certification
■ Certification Overview China classifies medical devices into classes I, II, and III based on their risk level and evaluates
[INDIA] CDSCO Medical Device Certification
■ Certification Overview The Indian CDSCO classifies medical devices into a total of four classes, from A to D, based
[VIETNAM] DMEC Medical Device Certification
■ Certification Overview The existing medical device management department, DMEC (Director of Medical Devices and Construction), was completely abolished, and
[THAILAND] Thailand FDA Medical Device Certification
■ Certification Overview In accordance with Thai medical device regulations, medical devices imported into Thailand must obtain a prior authorization
[TAIWAN] Taiwan FDA Medical Device Certification
■ Certification Overview The agency regulating the registration and sale of medical devices in Taiwan is the Food and Drug
[PHILIPPINES] PFDA Medical Device Certification
■ Certification Overview The Philippines Food and Drug Administration (PFDA) is a regulatory agency under the Department of Health and
[MALAYSIA] MDA Medical Device Certification
■ Certification Overview The Medical Device Authority (MDA) is a federal statutory body under the Ministry of Health of Malaysia
[SINGAPORE] HSA Medical Device Certification
■ Certification Overview All medical devices imported into Singapore must undergo a registration process with the Health Science Authority (HSA).