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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.
Last updated on November 8th, 2021.
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
TIMEFRAME:
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
SPECIAL REQUIREMENTS:
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
For detailed device-specific compliance information for each market, including Indonesia, to expedite the preparation of your medical device or IVD registration application.
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