MFDS Regulatory Affairs Training Program for International Teams

About This Program

A 5-day deep-dive training program in Korean medical device regulation, designed for regulatory affairs staff at foreign manufacturers building Korean operations. The program covers the full Korean RA landscape — MFDS registration, KGMP coordination, KLH operations, post-market regulation, and reimbursement — at the depth required for an RA staff member to handle ongoing Korean work without continuous external support.

This is not an introductory webinar. It is an applied training program structured around real-world situations RA practitioners face when handling Korean submissions and operations.

Who This Is For

• RA staff at foreign medical device manufacturers preparing to take on internal Korean RA responsibility
• New RA hires being onboarded into Korean RA roles
• Senior RA staff at companies extending their first products into Korea
• Cross-functional team members (QA, clinical, commercial) who need a working understanding of Korean RA to coordinate with their RA colleagues

The program is delivered in English. Korean is taught contextually (key MFDS terminology, common phrases in regulatory correspondence, how to read a Korean approval letter), but the program assumes participants do not need to function in Korean directly. They need to function with Korean RA support.

What You Will Learn

Day 1: Korean Medical Device Regulatory Framework

• The MFDS organizational structure and how to engage with it
• The Medical Device Act and its key articles
• The classification framework: how Korean classification works, where it diverges from FDA and EU
• Korean medical device item codes: structure, how they are assigned, when they can be challenged
• The full Korean registration lifecycle from pre-submission to clearance
• Class I vs Class II vs Class III pathways: practical differences
• Common pitfalls: classification mistakes, intended use phrasing, predicate/equivalent selection

Day 2: Submission Preparation and MFDS Interaction

• The Korean technical file structure: STED format adapted for Korean expectations
• Required content per class
• Translation strategy: what gets translated, who translates, how to manage translation quality
• KGMP coordination: how KGMP and MFDS interact in the submission process
• Submission filing through the MFDS portal: practical mechanics
• RAI (Request for Additional Information) response strategies
• Pre-submission meetings: when to request them, how to prepare, what to expect
• Common deficiency patterns and how to avoid them

Day 3: KGMP and Quality System Coordination

• KGMP framework: how it relates to ISO 13485 and what is uniquely Korean
• The Korean Quality Manual: structure, content, distinction from translation
• Korean-specific QMS procedures: import records, complaint routing, KLH coordination
• Site readiness and audit preparation overview (deeper KGMP-specific training available separately)
• Manufacturing process validation for KGMP scope
• Supplier control for Korean operations
• Sterilization validation documentation expectations

Day 4: Post-Market Operations and KLH

• The 2026 vigilance reporting framework: timelines, mandatory fields, KLH responsibility
• PMS planning for Korean operations
• License maintenance: annual reports, renewals, labeling changes, KGMP surveillance
• KLH operations: independent vs distributor-tied structures, decision criteria, switchover mechanics
• Korean complaint handling: KLH intake, translation, routing to manufacturer
• Adverse event response: the 7-day clock for deaths and operational implications
• Labeling change notifications: when required, how to file
• Korean post-market audit preparation

Day 5: Reimbursement, Special Topics, and Capstone

• HIRA framework: routine reimbursement, new code, sub-code applications
• NECA framework: new health technology assessment for novel devices
• Reimbursement evidence requirements: clinical, economic, comparative
• International reference pricing and its implications for Korean launches
• Cybersecurity submissions under the 2026 MFDS framework
• SaMD-specific topics: AI/ML approval, software change control, Korean PCCP-equivalent landscape
• Capstone exercise: participants take a worked sample case (a hypothetical device entering Korea) and develop the regulatory strategy, classification opinion, submission outline, and KLH structure recommendation

Program Format

Standard format:

• 5 consecutive days (Monday–Friday)
• On-site at Leanabl Seoul office (or alternative venue for multi-participant cohorts)
• 6–12 participants (kept small for working session quality)
• Bilingual delivery (primary English, contextual Korean)
• Materials in advance for pre-reading
• Workshop-style exercises throughout

Alternative formats:

• 2 × 2.5-day blocks (with a 2-week gap) for participants who cannot dedicate one continuous week
• Remote synchronous delivery for participants who cannot travel to Seoul
• Customized on-site delivery at the manufacturer's headquarters for cohort of 6+

Pre-Program Preparation

Participants are asked to:

• Review their company's current Korean RA status (any existing approvals, pending submissions, KLH arrangements)
• Identify 5–10 specific Korean RA questions they want addressed during the program
• Pull (with confidentiality protections) a representative recent regulatory submission or correspondence to use as workshop material
• Reserve uninterrupted attendance throughout the 5 days

A pre-program 1-hour intake call between Leanabl and the participant scopes the participant's specific situation. The program content is calibrated to the cohort — a cohort of RA managers handling new Korean entry has different emphasis than a cohort of RA staff already supporting Korean operations.

What Participants Leave With

The 5-day program produces:

• A complete Korean RA reference workbook (~200 pages, bilingual where useful)
• Templates for the most common Korean RA outputs: submission cover letter, RAI response framework, change notification, annual quantity report
• A personalized 90-day Korean RA action plan based on the participant's company context
• Direct contact channels with Leanabl Korea RA leads for post-program follow-up
• Optional follow-up 1:1 coaching sessions (monthly for 6 months, separately arranged)

The deliberate intent is that participants emerge able to handle the majority of Korean RA work for their company without continuous external support, with Leanabl available for specific complex situations rather than as an ongoing operational dependency.

Why a 5-Day Format

A practical question: why 5 days rather than something shorter?

Several reasons. Korean RA is genuinely deep — the regulatory framework has Korean-specific elements that take time to absorb. Compressed formats (1-2 days) consistently produce surface familiarity rather than working competence. The capstone exercise on Day 5 specifically requires participants to integrate the prior days' content in a structured situation, which is where the actual learning consolidates.

For participants who genuinely cannot dedicate 5 days, the program is offered in split formats. Going below 4 days of total content significantly reduces the working competence outcome.

Post-Program Continuing Engagement

For participants and companies wanting ongoing support after the training:

• Monthly Korea RA office hours (separately arranged): Leanabl RA leads available for participant questions
• Quarterly Korea regulatory updates: structured briefings on MFDS changes affecting the participant's product scope
• Just-in-time consultation: per-engagement support for specific complex situations
• Integration with Korea Device Registration, Korea Full Market Authorization, or other solutions for specific projects

The continuing engagement is optional; many participants emerge from the training capable of handling routine Korean RA internally and only engage Leanabl for genuinely specialized needs.

How to Apply

Programs are offered quarterly, with cohorts kept small. Application is through the standard contact channel. Lead time for cohort programs is typically 8–12 weeks; bespoke single-company programs can be scheduled at shorter notice.

Where Leanabl Plugs In

This training is part of the Training service offering. For companies wanting structured internal capability building rather than continuous consulting dependency, the training is paired with select solutions for specific operational needs. The training also serves as preparation for companies engaging Korea Total Access or the Korea Full Market Authorization program.