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Multi-Market Submission Strategy

When submitting to multiple regulators globally — including MFDS — a well-planned strategy can significantly reduce duplication of effort.

Leveraging IMDRF alignment​

MFDS has aligned its STED format with the IMDRF STED. A single well-prepared STED can form the basis for submissions to MFDS, FDA, TGA, and Health Canada with jurisdiction-specific supplements:

STED sectionGlobalKorea-specific addition
Device descriptionCommonKorean product code; Korean product name
Risk managementISO 14971 — commonNo major additions
Clinical dataCommonKorean clinical data if required by MFDS
LabellingMarket-specificKorean-language label required
TestingIEC/ISO — commonTest reports from MFDS-recognised labs

Sequence recommendations​

For most manufacturers, the recommended submission sequence is:

  1. First — FDA 510(k) or PMA / EU CE marking (largest markets; most developed guidance)
  2. Second — Korea, Australia, Canada (use FDA/CE data as base)
  3. Third — Singapore, Southeast Asian markets

Korean MFDS generally accepts FDA or CE clinical data with appropriate Korean supplement.

Korea-specific items to plan for​

  • KGMP / foreign GMP certificate — obtain early; can be on the critical path
  • Korean-language labelling — requires translation lead time
  • MFDS-recognised lab testing — if not already done using IEC/KS standards

Korea-specific items to plan for​

"Critical Timeline Note: KGMP certificate acquisition typically requires 3–6 months and must be completed before MFDS will accept a device application (품목허가). Begin the GMP certification process 6–9 months before your planned Korean submission to avoid delays. Do not consider filing to MFDS until KGMP certification is in hand."