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Emergency Use Authorization (EUA)

Overview​

Indonesia has an Emergency Use Authorization (EUA) pathway that allows unregistered medical devices to be used during a declared public health emergency. This pathway was most prominently used during the COVID-19 pandemic to enable rapid access to diagnostic tests, ventilators, PPE, and vaccines.

The EUA for medical devices in Indonesia is based on provisions within the existing health emergency and medical device regulatory framework under the Ministry of Health. Specific implementing regulations are issued at the time of each emergency declaration.

Eligibility Criteria​

To qualify for EUA consideration:

  • A public health emergency must have been formally declared by the Indonesian government
  • The device must address the specific condition or threat that triggered the emergency
  • There must be no adequate, approved alternative available in sufficient quantity to meet the need
  • Evidence of safety and preliminary efficacy must support the intended use (requirements are less stringent than full registration, reflecting the emergency context)
  • The device must be authorised or approved for the same use in at least one reference jurisdiction (FDA, EMA, or equivalent) or have credible evidence of effectiveness

EUA Application Process​

  1. Submit application to Kemenkes (Directorate of Medical Devices) through the appropriate channel specified in the emergency declaration regulations
  2. Provide available safety and performance data (pivotal studies, international authorisations, manufacturer data)
  3. Kemenkes conducts expedited review — timelines significantly compressed compared to standard registration (days to weeks)
  4. EUA issued for specific device, specific use, specific emergency context

EUA Conditions and Limitations​

An EUA is issued with conditions, typically including:

  • Limited to the duration of the declared emergency
  • Use restricted to the specific emergency indication
  • Mandatory adverse event and performance reporting to Kemenkes
  • Distribution records required for all EUA-covered product
  • Labeling requirements (may be modified from standard requirements given emergency context)
  • Post-emergency transition plan required

Transition After Emergency Ends​

When the public health emergency is lifted:

  • EUAs are typically revoked or converted to conditional standard registrations
  • Manufacturers wishing to continue distributing the device must submit a full NIE registration application
  • Kemenkes may grant a transitional period to allow EUA-covered product already in the market to be sold down
  • Begin standard NIE registration proceedings during the emergency period to avoid a market access gap