IVD Device Product Registration in Indonesia

IVD device product registration in Indonesia is relatively fast and inexpensive. Prior to importation, medical and IVD devices must receive a registration number and product license (AKA marketing license) issued by the Ministry of Health to a local, licensed distributor.  Reference country approval is required prior to registering an IVD device in Indonesia.

IVD device definition and classification in Indonesia closely follow GHTF guidelines and are being harmonized according to the ASEAN Medical Devices Directive (AMDD).  Official guidance on timelines and fees for the processing IVD devices depends on classification.