In Vitro Diagnostics: HIV Test Kit Registration in Indonesia

In Indonesia, an HIV disease test kit has to be tested locally before the product can be submitted for registration with the Ministry. The local clinical test must be conducted by the clinical pathology laboratory of the national government hospital.
Like other medical devices, in vitro diagnostic devices (IVDs), such as HIV test kits, are highly regulated by the Ministry of Health of Indonesia. The registration documents for in vitro diagnostic devices are similar to those required for medical devices, with some additional mandatory requirements: