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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 품목허가.

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.

Cost and supply ​ The manufacturer or foreign entity must typically bear the cost of device supply during expanded access use. Commercial pricing is not permitted during this phase. MFDS may require the manufacturer to provide the device at cost or free of charge.

MFDS typically reviews expanded access applications within 7–14 days of submission. Approved expanded access may be granted for a specific duration (usually 6–12 months) and requires the treating physician to provide safety follow-up reports at specified intervals. The manufacturer must track and report any adverse events associated with expanded access use, and MFDS may revoke approval if safety concerns emerge.