Registering a medical device in Korea involves navigating a stringent regulatory process governed by the Ministry of Food and Drug Safety (MFDS). While much has been written about Korea’s classification system and regulatory pathways, one critical aspect often overlooked is the documentation itself. For manufacturers aiming to bring their medical devices to market in Korea, understanding the exact documentation required is just as important as understanding the process. This article offers a detailed look at the types of documents typically required during the MFDS registration process.
The MFDS Review Process in Context
The MFDS evaluates medical devices through a multi-tiered approach that includes classification, safety and efficacy reviews, and conformity assessments. While the regulatory framework outlines which routes a product must follow, the documentation forms the backbone of every successful submission. The extent and type of documentation required vary depending on the classification of the device (Class I to IV). Higher-risk devices (Class II and above) are subject to more rigorous documentation demands, including technical dossiers, clinical evaluations, and labeling reviews. However, even Class I devices must meet basic documentation standards to demonstrate conformity. Higher-risk devices also require a KGMP audit, which will be discussed in another article.
Key Categories of Required Documents
Using an actual checklist prepared for an MFDS submission, we can identify two major documentation sections that applicants must prepare: A. Product & Manufacturer Information and B. Test Reports. Below is typical information required for a Class 3 device registration in Korea.
- Product & Manufacturer Information
This section comprises core administrative, descriptive, and supporting documents about the product and its manufacturing background:
- Item List to be Registered: A full list of models, configurations, and part numbers intended for registration in Korea.
- Catalog or Brochure: Official marketing materials showing images, product features, and SKU references.
- Instructions for Use (IFU) or User Manual: A comprehensive guide covering intended use, usage instructions, safety warnings, contraindications, maintenance, and disposal.
- Label Samples: Sample product labels showing product name, part number, manufacturer, expiry date (if applicable), and regulatory marks.
- EN ISO 13485 Certificate: A valid certificate for the actual manufacturing site, confirming the existence of a compliant quality management system.
- Color Photos of Products: External photos of the front, back, side, packaging (if sterile), and any digital interfaces or touchpoints.
- Identification of Components: A photographic or diagrammatic breakdown of internal and external components, including accessories.
- Principle of Action: A brief document explaining how the product functions, potentially supported by published literature.
- Shelf-Life Information: Provided if applicable, detailing product stability and expiry period.
- Packaging Information: Description of packaging unit, structure, and labeling.
- Storage Conditions: Required information on optimal environmental conditions for storage and transport.
- Dimensional Drawings: Engineering diagrams with detailed measurements and scale, usually provided in PDF or CAD format.
- Raw Material Specifications: A description of raw materials used in the product, including part names, manufacturers, and specifications. This is essential for material safety and traceability.
- Statement of Biocompatibility: A declaration specifying whether biocompatibility testing is applicable. If applicable, it should cite test methods and summarize outcomes.
- List of Parts, Components, and Accessories: A comprehensive breakdown identifying all components and supporting elements associated with the device.
- Block Diagram: A schematic overview showing the structural relationship and interaction among components.
- Isolation Diagram: Illustrates electrical insulation and protective measures within the device design, crucial for powered devices.
- Software Information: Overview of software architecture, functionality, and classification level per IEC 62304.
- Cybersecurity: Description of security features implemented to protect patient data and device integrity, including encryption, authentication, and update mechanisms.
- Equivalence of Models: Document explaining similarities and differences among submitted models and any previously approved versions.
- Comparison with Competitive Products: A technical and clinical comparison with equivalent products on the market to contextualize safety and efficacy.
- Information on the Background/History of Development: Overview of the development process, including R&D rationale, target indications, and key milestones.
- Current Status of Approvals in Foreign Countries: A list or summary of marketing authorizations in jurisdictions outside Korea (e.g., FDA, CE Mark), including copies of certificates if available.
- Test Reports
This section includes documents and data generated through laboratory or bench testing that support the product’s safety and performance:
- Electrical Safety and EMC Test Report: For powered devices, proof of compliance with electrical and electromagnetic compatibility standards such as IEC 60601 series.
- Biocompatibility Test Report: If the product has direct or indirect contact with the body, test results from ISO 10993-compliant evaluations (e.g., cytotoxicity, sensitization, irritation).
- Performance Test Report: Empirical data showing that the device functions within intended performance specifications. May include bench test summaries, reproducibility analysis, or clinical performance data.
These technical reports are essential for the MFDS to evaluate product compliance with Korean safety and quality expectations. Incomplete or outdated reports can significantly delay the registration process.
Common Pitfalls and Practical Tips
Many delays in the MFDS registration process stem from incomplete or poorly prepared documentation. Below are several common pitfalls and how to avoid them:
- Missing or Inconsistent Part Numbers: Ensure all documentation (manuals, catalogs, labels) uses the same part numbers throughout.
- Low-Quality Images: Submit high-resolution, clearly labeled photos. Avoid cellphone snapshots.
- Incomplete Manuals: The IFU should not only describe how to use the product but also include warnings, contraindications, and troubleshooting guidance.
- Shelf-Life Confusion: Only provide shelf-life information if applicable, and ensure it is consistent with labeling and packaging documents.
- Language Requirements: If documents are not translated into Korean or lack dual-language formatting, MFDS may require resubmission.
To streamline the process, manufacturers should start preparing these documents as early as possible in the product lifecycle.
Conclusion
Document readiness is one of the most critical and underestimated parts of medical device registration in Korea. While knowing the regulatory pathways is important, having a complete, accurate, and well-presented set of documents is often what determines the speed and success of MFDS approval.
For companies preparing to register their device in Korea, it is highly recommended to develop or request a tailored documentation checklist, engage early with regulatory consultants with expert knowledge about Korea medical device registration, and implement good version control.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.