In Vitro Diagnostics: HIV Test Kit Registration in Indonesia

2018-10-24T14:40:43+08:00 May 29th, 2018|News & Events|
HIV

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:

  • Specificity, sensitivity, accuracy test reports
  • Packaging specification document

In Indonesia, HIV test kits must be tested locally before they commence the registration process with the Ministry. Local testing must be conducted by the clinical pathology laboratory of the national government hospital – Rumah Sakit Cipto Mangunkusumo (RSCM). The authorized distributor must submit an application and the head of the laboratory will provide the test protocol and other necessary information. At this point, the distributor can import product samples and the test protocol can support customs clearance. The laboratory requires at least 3 (three) batches of the product to be tested; this is due to the number of tests that the laboratory is required to perform on the product. Local testing for an HIV test kit is expected to take at least 3 months, depending on the workload of the laboratory. The testing costs IDR 40,000,000 or approximately USD 3000.