Reclassification Requests
MFDS may reclassify a device based on new evidence, safety data, or international harmonisation. Manufacturers/importers may also petition for reclassification.
Grounds
- New clinical or scientific evidence changes the risk assessment
- Technological advances reduce risk
- International reclassification by FDA, TGA, or EU bodies
- Post-market safety data reveals higher or lower risk than current grade
Process
- Submit a reclassification petition via MFDS eSubmission portal
- Include a comprehensive technical justification and supporting evidence
- MFDS reviews, may seek external expert input
- MFDS decision published; Classification Table updated if approved