: 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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