Indonesia: Online Registration System for Medical Devices

As part of its recent campaign to modernize and expand its national healthcare system, Indonesia has implemented an e-registration system for medical devices. While the documentation requirements are much the same as other ASEAN countries (distribution license and letter of appointment for importers, ASEAN Common Submission Dossier Template registration form, and 5-year validity), Indonesia’s system will be accessible on the internet for medical device registrants.

Through the Indonesia National Single Window (INSW), Indonesia plans to integrate the major components of medical device registration to provide a more seamless, unified system. Companies can apply for distribution licenses, production licenses, and registration numbers through the E-Registration Online service. This application information will appear on the INSW, allowing faster and more efficient customs release and cargo clearance.

Companies that sign on through the INSW will be able to simultaneously access the licensing system, information on rules and regulations related to their products, and export/import information. With nearly ten times as many medical devices registered by foreign over local companies (approx. 38,000 foreign vs. 3,800 local, 2011 numbers), the system should greatly improve service and speed for Indonesian medical device customers, distributors, and foreign manufacturers.