Medical Device Registration and Approval in Indonesia

General country-specific regulatory information is provided on this page for medical device registration and approval in Indonesia.

We review our Regulatory Information frequently; please check back often for updates

Medical Device Regulations and Classification in Indonesia

REGULATORY AUTHORITY: Ministry of Health (MoH)

CLASSIFICATION SYSTEM: Medical Devices/IVDs: Class A/B/C/D or 1/2/3


Actual timeline based on experience:

Medical Devices/IVDs Class A – 1 to 2 months

Medical Devices/IVDs Class B/C – 3 to 4 months

Medical Devices/IVDs Class D – 4 to 6 months


On-site Audit: Not required.

Local Tests/Permit: May be required for some devices such as disposable sterile syringes, HIV test products, medical devices that contain/transmit radiation, medical devices that transmit radiofrequency/Bluetooth.

Local Clinical Evaluation or Studies: Not required.

LOCAL FEES (New Application):

Medical Devices/IVDs

Class A: USD 125

Class B/C: USD 225

Class D: USD 350

LOCAL FEELS (Manufacturer): No manufacturer registration is required. The local authorized representative, however, must be an establishment that holds a valid Medical Device Distributor License (MDDL) and implements a Good Distribution Practice of Medical Device (GDPMD).

LICENSE VALIDITY: Maximum 5 years (depending on the validity of authorization letter issued by the foreign manufacturer).

LICENSE TRANSFER: License transfer is possible but new registration is required.

AUTHORIZED REPRESENTATIVE:  A solely local authorized representative should be appointed by an overseas manufacturer through official Letter of Authorization (LoA).

Other Southeast Asian Countries: Cambodia, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam

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For detailed device-specific compliance information for each market, including Indonesia, to expedite the preparation of your medical device or IVD registration application.


Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.

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