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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​

  1. Submit a reclassification petition via MFDS eSubmission portal
  2. Include a comprehensive technical justification and supporting evidence
  3. MFDS reviews, may seek external expert input
  4. MFDS decision published; Classification Table updated if approved

MFDS decision published; Classification Table updated if approved​

The reclassification review process typically takes 2–4 months. Once approved, the updated classification is effective upon publication in the Classification Table notification. Manufacturers with existing approvals under the previous grade must comply with the new requirements within a specified transition period.