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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 β€” typically valid for 2–4 years and must be converted to full ν’ˆλͺ©ν—ˆκ°€ (marketing authorization) upon satisfactory submission of required post-market data

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: β€” Review evidence against the original conditions β€” Grant full approval (ν’ˆλͺ©ν—ˆκ°€) if conditions are satisfied β€” Request additional data if evidence is insufficient β€” 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.