Medical Device Registration in Indonesia

Medical device registration in Indonesia is the process of obtaining Izin Edar Alkes, or a medical device distribution permit, before regulated medical devices can be imported, distributed, or sold.

Medical device registration is handled under Kementerian Kesehatan through the applicable registration system, including Regalkes.

Regalkes is the online registration system used for Alkes and PKRT licensing, including medical device distribution permit applications.

Izin Edar Alkes is the distribution permit required for medical devices before they can legally circulate in Indonesia. It is also commonly linked to the product’s NIE.

AKL generally refers to imported medical devices, while AKD generally refers to locally produced medical devices.

Medical devices are generally classified into risk classes based on intended use, product function, technology, and potential risk. The exact class should be reviewed before submission.

Common documents include CSDT files, product specifications, label and IFU files, manufacturer documents, certificates, test reports, authorization letters, and local applicant information.

Yes. Imported medical devices generally need an eligible Indonesian company, distributor, importer, or registration holder to support the application and market compliance.

IDAK is relevant to medical device distribution. The distributor or local company involved in medical device circulation should review IDAK and related distribution requirements.

After approval, companies must maintain product compliance, monitor validity, manage renewals or variations, and keep supporting documents ready for review or inspection.