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MFDS Q&As and FAQs

MFDS publishes Question and Answer (Q&A) documents and FAQs on its website. These are valuable practical guides to how MFDS interprets regulatory requirements.

Types of Q&A documentsโ€‹

  • General FAQs โ€” frequently asked questions on the Medical Devices Act and IVD Act
  • Topic-specific Q&As โ€” e.g., UDI-K FAQ, SaMD FAQ, IVD Act transition FAQ
  • Pre-consultation guidance โ€” how to structure a pre-submission enquiry to MFDS

Pre-consultation meetings (์‚ฌ์ „ ์ƒ๋‹ด)โ€‹

For complex or novel devices, MFDS encourages pre-consultation meetings before formal application. These clarify MFDS expectations and can prevent time-wasting rejections.

Submit pre-consultation requests via the MFDS eSubmission portal.

Using Q&As in submissionsโ€‹

Q&A documents represent MFDS's current interpretation of the regulations. Referencing a relevant Q&A in a submission can strengthen a regulatory position.