The IVD device registration process 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 of a Class I IVD device application is 30 days and approximately US$115 (Indonesian Rupiah 1,500,000). Class IIa and IIb IVD devices require 60 days and US$230 (Indonesian Rupiah 3,00,000). Class III devices are processed in 90 days for a fee of US$340 (Indonesian Rupiah 5,000,000). Note that for novel devices to Indonesia, the Director General may request the expert team to provide scientific review of the application which will add time but no additional fee to the process.
IVD instruments will require IEC 61010-1:2001 reports and Class II and III IVD devices will require performance/characteristic evaluation reports. Finally, the application for HIV reagents and kits requires performance test reports generated at the Indonesia Reference National Laboratory Hospital (RSCM).
Once issued the product license is valid for up to 5 years.