Approval Conditions and Post-Approval Changes
Approval conditions
MFDS may impose conditions such as mandatory PMCF studies, restricted indications, or time-limited approval. Non-compliance may lead to suspension or cancellation.
Post-approval changes
| Change | Required action |
|---|---|
| Minor labelling change | 변경신고 (Change Notification) |
| Intended use change | 변경허가 (Change Authorization — full review) |
| Significant design change | 변경허가 |
| Manufacturing site change | 변경신고 or 변경허가 (depending on significance) |
| New size/variant | 변경허가 |
Renewal
품목허가 certificates do not automatically expire, but must be kept current. Maintain active GMP certificate and notify MFDS of changes.
Related pages
PMCF conditions may require ongoing safety and performance data collection after approval. Approved devices remain valid indefinitely provided the GMP certificate and product status remain current; however, MFDS may require periodic documentation of compliance with approval conditions.