Korea MFDS registration · KGMP · On-site document review

Korea registration,
starting with an on-site review
at your facility.

Before major commitments or full document transfer, the early assessment can be carried out with direct cooperation at your facility when appropriate, ensuring clarity on MFDS feasibility and documentation requirements.

No need to send sensitive files at the first contact. Early assessment is performed inside your company.

Why Einstra

Three practical strengths in Korea MFDS and KGMP projects: on-site review, document control and reasonable pricing.

Strength 01

On-site focused review

Early assessment can be carried out inside your facility, based on your real processes and documentation flow.

  • Reviews performed within your environment when appropriate
  • Focus on how your actual system works in practice
  • Feasibility judged on real conditions, not only on paper
Strength 02

Minimal document transfer

Sensitive documents can remain under your control during the early stages of the project.

  • Initial discussions without sending full document sets
  • On-site or controlled-environment document review
  • Only the necessary files are shared when truly required
Strength 03

Reasonable, staged pricing

Work is divided into clear stages so that you only commit to the scope you actually need.

  • Discovery and initial assessment separated from full projects
  • Transparent scope and fees for each phase
  • You pay only for the stages you actually need in Korea

Core services for Korea MFDS & KGMP

The focus is Korean MFDS registration and KGMP audit readiness. Additional global alignment support is provided when appropriate.

MFDS strategy & feasibility

Korean MFDS registration strategy

Early technical evaluation may be conducted through direct collaboration with your team, clarifying classification, documentation gaps and feasibility before entering a full MFDS project.

  • Initial remote review based on summary
  • On-site feasibility assessment & gap list
  • Clear project scope before full engagement
KGMP audit preparation

Preparation for KGMP inspection

Preparation focused on practical readiness, document clarity and inspection flow.

  • Audit scenario mapping
  • Training for Korean inspection style
  • On-site support during audit period
Engagement model

Clear staged process

Projects progress in structured stages to reduce uncertainty.

  • Discovery → Initial assessment phase → Detailed plan → Full project
  • Transparent scope at each stage
  • Predictable timelines and deliverables
Annex · Global document alignment

Once the Korean strategy is defined, documentation can be aligned with EU / US requirements as needed, avoiding unnecessary duplication.

  • Comparison of Korean vs EU/US document sets
  • Reusable core document packages for multiple markets
  • Long-term documentation strategy for future submissions

Project examples

Real patterns from anonymised projects with overseas manufacturers.

Class II manufacturer

On-site feasibility assessment

CE certified, no Korea experience

A 4-day on-site review mapped product structure, documentation status and MFDS pathways, enabling a realistic choice of entry level.

KGMP audit

Practical on-site support

Factory overseas

Support during the full audit period, including Q&A preparation and documentation flow.

No internal RA

Stepwise roadmap

Small manufacturer

Projects divided into manageable steps: documentation basics → risk management → MFDS → KGMP.

OEM / Private label

Global alignment

Multiple partners

Consolidated requirements across importer, MFDS and global documents, reducing repeated work and inconsistencies.

Background

Experience with MFDS submissions, KGMP inspections and cooperation with overseas manufacturers.

Projects aim for long-term stability — not only approvals, but documentation that can withstand future audits and extensions.

Early work is hands-on: reviewing documents at your facility and understanding how your existing system matches Korean expectations.

Contact

A brief outline of your products and current status is enough for an initial discussion.

Whether it’s MFDS feasibility, KGMP readiness or document alignment, the first step is to understand your situation.

· Email or video call to begin
· On-site visit when appropriate
· Information used only for consulting discussions
If you prefer a call, you can add your time zone and preferred time windows.