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 documents
- General FAQs — frequently asked questions on the Medical Devices Act and IVD Act
- Topic-specific Q&As — e.g., UDI-K FAQ, SaMD FAQ, IVD Act transition FAQ
- Pre-consultation guidance — how to structure a pre-submission enquiry to MFDS
Pre-consultation meetings (사전 상담)
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 (의료기기 전자민원) using the dedicated 사전상담 (pre-consultation) module. Provide detailed product information and specific regulatory questions to facilitate efficient MFDS review.
Using Q&As in submissions
Q&A documents represent MFDS's current interpretation of the regulations. Referencing a relevant Q&A in a submission can strengthen a regulatory position.