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Conditional Marketing Authorization

Conditional Marketing Authorization allows MFDS to approve novel or innovative devices based on preliminary evidence, with conditions requiring additional data collection post-approval.

When it applies​

Conditional authorization may be granted when:

  • The device addresses a serious or life-threatening condition with limited treatment options
  • Preliminary evidence is sufficiently promising but a full evidence package is not yet available
  • The benefit of early patient access outweighs the risk of residual uncertainty

Conditions typically imposed​

  • Mandatory post-market clinical follow-up (PMCF) study
  • Restricted indication or patient population
  • Enhanced pharmacovigilance/device surveillance
  • Time-limited approval — typically valid for 2–4 years from initial approval. The conditional authorization must be converted to full 품목허가 (marketing authorization) upon satisfactory submission of required post-market data, or the approval will expire and the device must be removed from the Korean market.

Risk to the manufacturer​

If the conditions are not fulfilled (e.g., PMCF study not completed), MFDS may revoke the conditional authorization. Planning for compliance is essential from the outset.

Re-evaluation and conversion ​ Upon submission of required post-market data, MFDS will: — Review evidence against the original conditions — Grant full approval (품목허가) if conditions are satisfied — Request additional data if evidence is insufficient — May revoke approval if the device is shown to have unacceptable risk-benefit profile

Conditional authorization is typically valid for 2–4 years pending data submission.

The post-market clinical follow-up (PMCF) study design must be agreed upon during MFDS pre-submission consultation and included in the conditional authorization approval letter. Typical PMCF studies monitor safety and efficacy outcomes in real-world populations. Data submission must include completed case report forms, safety analysis, and efficacy endpoints as specified in the original conditions. MFDS review of PMCF data for conversion typically requires 3–6 months.