Indonesia Medical Device Classification Finder
Type a device name to find its risk class, from A to D, and what that means for registering it in Indonesia.
What the four risk classes mean
Class is set by risk under Permenkes 11/2025. It drives the evaluation timeline and the post-market obligations.
Same 33-document dossier as every other class. Depth of design verification is lighter.
Post-market surveillance report required at renewal for IVD reagents only.
Post-market surveillance report required at renewal.
Longer correction rounds (15 days). Post-market surveillance report required at renewal.
The notification route
Some low-risk Class A devices, home-use, non-sterile, and not IVDs, qualify for a notification route instead of full registration. The notification route is faster and has fewer requirements than a standard medical device registration. If you are not sure whether your device qualifies for notification approval, talk to our regulatory experts in Indonesia. We will assess the classification and handle the registration process on your behalf.
Indonesia medical device classification — FAQ
How is a medical device classified in Indonesia?
Indonesia uses the four ASEAN risk classes — A (low), B (low–moderate), C (moderate–high) and D (high). KMK No. HK.01.07/MENKES/4745/2021 lists 2,629 device types with their class. Type the device name above to find where it sits.
Who regulates medical devices in Indonesia — is it BPOM?
No. Medical devices are regulated by the Ministry of Health through the Regalkes portal, which issues the izin edar (marketing authorisation). BPOM handles food, drugs and cosmetics — not medical devices.
Does the risk class change the documents I have to file?
No. All four classes file the same dossier. The class mainly sets the evaluation timeline, the length of the correction rounds, and the post-market surveillance obligation at renewal. The old rule requiring clinical evidence only for Class C and D was under Permenkes 62/2017, which has been repealed.
What is the notification route and does my device qualify?
For 34 named Class A device types that are home-use, non-sterile and not IVD, there is a simplified notification route of about 12 working days. Everything else goes through full registration. The tool flags a device when it qualifies.
Can a foreign company register its device in Indonesia directly?
No. The izin edar must be held by an Indonesian entity with an IDAK distribution licence and a CDB certificate, or by an appointed Indonesian distributor. Emerhub sets up the entity or acts as your route to market, then handles the Regalkes submission.
Register your device in Indonesia
Tell us the device, its risk class if you know it, and where it is manufactured. Our Jakarta team confirms the class, puts the licensed holder in place, and runs the Regalkes filing through to your NIE.
RT.7/RW.2, Kuningan
Jakarta 12950, Indonesia