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.



ARE YOU INTERESTED IN REGISTRATION IN INDONESIA? REQUEST A FREE QUOTE>​
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  • Phone +1 604.681.6888
  • Fax +1 604.688.6822
  • info@arazygroup.com
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  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

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