: Medical devices are regulated by the Indonesian National Agency of Drug and Food Control (NA-DFC). CLASSIFICATION SYSTEM:
Risk Based Classification: Classes I, IIa, IIb and III. TIMEFRAME:
The registration process takes 45 working days for Class I devices, 90 working days for Class IIa and IIb devices, and 120 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 January 15, 2018.
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