Medical Device Checker:
Your Medical Device Classification Tool for Indonesia
Use our Medical Device Checker to find your product's risk class in Indonesia. Answer a few questions about the device's intended use and function, and this medical device classification tool identifies the matching class, plus what's needed to complete your dossier.
What risk class is your device in Indonesia?
A device's classification determines its dossier requirements, evaluation pathway, and associated fees based on functional behavior, not product naming. Our medical device classification tool walks you through the relevant details and identifies the corresponding class, along with every rule applied.
Indicative guidance only — not a legal reference.
Classification depends on the manufacturer's stated intended use and the full technical file, and a device
meeting several rules always takes the highest class. Combination devices are classified separately.
The evaluating authority makes the final determination and may reach a different conclusion. Confirm your
specific case before preparing a submission.