Securing Korea Good Manufacturing Practice (KGMP) certification is a key regulatory milestone for medical device registration in Korea. The KGMP system, overseen by the Ministry of Food and Drug Safety (MFDS), ensures that medical devices are consistently produced and controlled according to quality standards. One of the most critical but often misunderstood parts of the KGMP application is documentation. This article outlines the required documents for KGMP certification based on a real-world checklist, split into two parts –1. Manufacturer-level documentation and 2. Product-specific documentation.

Manufacturer Documentation for KGMP

These documents must demonstrate a company’s quality management infrastructure. These documents must also prove that the manufacturer meets international quality standards and has internal controls to ensure product safety.

1. GMP Certificate (MDSAP)
   A valid EN ISO 13485 certificate issued under the Medical Device Single Audit Program (MDSAP). This certificate must be based on an on-site audit by an approved certification body and should cover the manufacturing facility intending to export medical devices to Korea.
2. Audit Report with CAPA
   The most recent MDSAP audit report, along with documentation of corrective and preventive actions (CAPA). This demonstrates the company’s ability to address non-conformities and maintain a continuous improvement approach.
3. Quality Manual
   A complete and current version of the manufacturer’s Quality Manual, outlining the quality management system (QMS), scope, exclusions, and the responsibilities of key management.
4. Standard Operating Procedures (SOPs)
   • SOP for Control of Records: Covers document creation, revision, approval, and retention.
   • SOP for Organizational Responsibilities: Defines the duties and authorities of key personnel.
   • SOPs for Traceability and Adverse Event Reporting: Demonstrates preparedness for post-market surveillance and recalls.
5. QMS Inter-relationship Diagram
   A visual representation of how the different elements of the QMS interact, including design, production, quality control, and post-market activities.
6. Statement of QMS Correlation
   A formal statement or declaration showing how QMS processes relate to one another and how they comply with Korean regulatory expectations. Templates are typically provided by local Korean in-country representatives.

These documents are evaluated to assess the reliability and maturity of a manufacturer’s quality management system. Korean regulators place high importance on the alignment of global standards (like MDSAP) with local compliance frameworks.

Product-Specific Documentation for KGMP

These documents must substantiate the product’s design, specifications, manufacturing process, and quality control.

1. Product List for KGMP Application
   A listing of models or product lines included in the application. This forms the basis for determining product scope and conformity assessments.
2. Device Master Record (DMR)
   A complete DMR or equivalent technical file including:
   • Design drawings and specifications
   • Quality assurance procedures
   • Test methods and acceptance criteria
3. IFU or User Manual
   Instructions for Use, including safety warnings, usage guidelines, contraindications, and handling instructions.
4. Dimensional Drawings
   Engineering diagrams issued by the manufacturer, including physical measurements, tolerances, and labeling locations.
5. Raw Material Specifications
   A table listing all major components and raw materials, including material types, suppliers, and purpose. This document is vital for demonstrating traceability and biocompatibility.
6. Manufacturing Process Flowchart
   A high-level diagram outlining each step of the manufacturing process—from material intake and assembly to packaging and sterilization (if applicable).
7. Packaging Information
   Description of packaging materials and configuration, including unit size, sealing methods, and shelf life if applicable.
8. Product Label
   Label samples for the representative product. These must comply with Korean labeling regulations and include details like manufacturer, model, lot number, expiry date, and instructions.
9. Final QC Test Protocol (SOP)
   Standard operating procedures detailing the quality control steps before product release, including equipment used and acceptance criteria.
10. Final QC Test Report
    Batch records or final inspection results to demonstrate compliance with product specifications. These may include performance metrics and functional test data.
11. Sterilization Certificate & Report (if applicable)
    Data showing the product has been sterilized effectively, including method used (e.g., EO gas, gamma), residual level analysis, and validation data.

Together, these documents build a comprehensive profile of the product’s safety and performance. MFDS reviewers use them to verify consistency between the product’s design and its real-world manufacturing execution.

MDSAP and Audit Strategy

For manufacturers that have never undergone an MFDS audit, there is a near 100% likelihood that MFDS will require an on-site audit as part of the KGMP certification process. This typically involves a delegation of four Korean inspectors visiting the manufacturing facility in the U.S., EU, or another location.

However, if the manufacturer already holds a valid MDSAP certificate, it may be possible to leverage this certification to request a paper-based audit instead of a physical inspection. The feasibility of this option depends on several factors, and historically, the success rate is about 50%.

Key considerations include:

• KGMP Application Fee: Even if a paper-based audit is accepted, the standard KGMP application fee will still apply.
• MDSAP Format Compliance: The audit report must conform to the MDSAP F0019.1 format. Reports generated solely by the auditing organization (AO) will not be accepted.
• Validity Period: If MFDS accepts the MDSAP audit results, the validity of the KGMP certification will be tied to the expiration date of the MDSAP certificate.

Given these conditions, manufacturers are encouraged to work closely with local Korean regulatory experts to evaluate whether leveraging an MDSAP audit is a viable path for their specific product.

Additional Notes on Submission

• Language: Most documents must be submitted in Korean or in dual-language format.
• Templates: Many Korean in-country representatives (ICRs) provide standardized templates for declarations, process charts, and interrelationship diagrams. Using these can improve clarity and alignment.
• Document Readiness Tracking: Using a spreadsheet to monitor file names, version status, and review progress can reduce delays and ensure completeness.

Conclusion

Preparing for KGMP certification in Korea involves far more than a site audit. The documentation required at both the manufacturer and product levels is extensive and highly specific. By proactively compiling these materials—using a checklist like the one shared here—medical device manufacturers can avoid delays and reduce back-and-forth with MFDS reviewers.

If your company is beginning the KGMP application process, it’s essential to consult with experienced regulatory professionals familiar with Korean KGMP requirements. Please remember that passing Korea’s KGMP requirements is an important part of medical device registration in Korea.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)