MFDS Deficiency Letters After Submission Cost 4 to 8 Months. Find the Gaps Before You File.
Reaching design freeze is not the same as being ready to file with MFDS. Companies that submit at design freeze and discover gaps during MFDS review face deficiency cycles of 4 to 8 months per round — time that is irreversible once the submission clock starts.
A Structured Pre-Submission Audit Against MFDS-Specific Requirements — Before the Filing Window Opens.
We audit your verification and validation package, risk management file, and usability documentation against the specific requirements MFDS will apply during review — gaps are identified, classified by submission risk, and remediated before the MFDS filing is submitted.
Technical File Gap Analysis
A line-by-line audit of your V&V test reports, technical documentation structure, and labeling against MFDS STED requirements — confirming that test standards are MFDS-accepted, technical file structure matches Korean STED format, and documentation is in Korean where required.
Testing Management + Usability Engineering
Identifying missing or non-compliant test reports and coordinating supplemental testing against MFDS-accepted standards, plus reviewing your human factors and usability validation documentation against MFDS usability guidance — identifying gaps that MFDS reviewers flag most frequently.
Risk Management Documentation
Auditing your risk management file against MFDS STED risk documentation requirements — confirming risk traceability format, completeness of hazard identification, and post-market risk update obligations meet MFDS standards.
One Pre-Submission Audit Eliminates the Deficiency Cycle That Derails Most First-Time MFDS Filings.
MFDS Pattern Recognition Applied Before You File
MFDS deficiency cycles concentrate on the same categories of gaps in almost every submission from foreign manufacturers: test standards not accepted by MFDS, usability methodology misaligned with MFDS guidance, and risk documentation format that does not match STED requirements. We apply this pattern recognition to your technical file before you file.
Written Submission Readiness Confirmation
The engagement concludes with a written confirmation from Leanabl's senior regulatory team that the technical package is ready for MFDS submission — giving your team a documented basis for the internal go/no-go decision before filing.
First-Cycle MFDS Approvals for Manufacturers Who Engaged Pre-Submission.
First-Cycle Class II Approval for a North American Diagnostic Device
Conducted a full pre-submission gap analysis for a North American diagnostic device manufacturer — identified non-compliant test standards and a usability validation gap, coordinated supplemental testing and Korean user validation, and achieved first-cycle MFDS approval without deficiency.
SaMD Technical File Readiness for a European Digital Health Company
Audited the technical file of a European SaMD product against MFDS SaMD-specific requirements before submission — identified cybersecurity documentation gaps and risk traceability format issues, remediated all findings, and filed a submission that passed MFDS review in the first cycle.
A Submission-Ready Technical Package — With Every MFDS-Specific Gap Closed Before Filing.
Your first submission is your clean submission — because we applied MFDS pattern recognition to your technical file before you filed.
Start Your Pre-Submission Readiness ReviewFrequently Asked Questions
Common questions answered.