Indonesia
REGULATORY AUTHORITY: Medical devices are regulated by the Indonesian Ministry of Health (MOH).

CLASSIFICATION SYSTEM: Classification follows the EU model of risk-based Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The registration process takes 30 working days for Class I devices, 60 working days for Class IIa and IIb devices, and 90 working days for Class III devices.

LICENSE VALIDITY: Licenses issued in Indonesia expire after 5 years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

Last updated on March 17 2015.



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