Precedent (Clinical Trials Approved/Denied in Last 2 Years)
4 clinical trials approved from June 2012 to June 2014.
Product Registration Data Requirements
Medical device registration is through the Indonesian National Single Window (INSW), an electronic registration system that integrates the ASEAN Common Submission Dossier requirements, and applications for distribution licenses, production licenses, and registration numbers.
Product Registration Timelines
According to the International Diagnostics Center's Regulatory Overview of Indonesia, registration timelines are the following:
-30 days for Class 1
-60 days for Class 2
-90 days for Class 3
Product Registration Costs
According to the International Diagnostics Center's Regulatory Overview of Indonesia, fees are the following:
Class 1: 1.5 million Rupiah (125 USD)
Class 2: 3 million Rupiah (250 USD)
Class 3: 5 million Rupiah (400 USD)
Post Registration Pharmacovigilance Requirements
Mandatory reporting of serious adverse health events or death within 24 hours. Must include information on corrective action.
October 20, 2015.