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Expanded Access and Compassionate Use

Expanded access (also called compassionate use) allows patients with serious conditions and no alternative treatment options to access a medical device that has not yet received Korean ν’ˆλͺ©ν—ˆκ°€.

Eligibility​

Expanded access may be considered when:

  • The patient has a serious or life-threatening condition
  • No adequate approved treatment exists in Korea
  • The patient cannot participate in a clinical trial
  • Sufficient evidence exists of the device's safety and potential efficacy

Process​

  1. The treating physician applies to MFDS for expanded access approval for a specific patient
  2. MFDS reviews on a case-by-case basis
  3. If approved, the device may be imported and used for that specific patient only

Manufacturer's role​

The foreign manufacturer (via Korean agent/importer) must cooperate with the MFDS application by providing safety and technical information.