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Documentation Requirements
Prepare product descriptions, safety and performance evidence, and manufacturing-site quality records as connected evidence sets.
Volume is less important than consistency. Model names, intended use, configuration, test conditions and manufacturing-site information should describe the same product throughout the application.
Evidence-readiness checklist
For initial assessment, not a complete statutory submission list or a universal list of mandatory documents.
Product information to review first
| Evidence | Review points |
|---|---|
| Product and models | List the product, model differences and included components. |
| Intended use and mechanism | Explain who uses the device, its purpose and how it works. |
| Construction, materials and instructions | Gather product descriptions, materials information and instructions for use. |
Evidence requiring an applicability review
| Evidence | Review points |
|---|---|
| Safety and performance | Compare applicable standards with reports and relate tested models to the proposed application. |
| Clinical evidence | Review product characteristics and differences from existing devices before determining clinical-evidence requirements. |
| Manufacturing and quality | Identify sites and product groups, then separately review applicable quality-assessment scope and available records. |
Check consistency between documents
| Area | Points to confirm |
|---|---|
| Product identity | Compare product/model names, manufacturer and site across documents. |
| Intended use and performance | Compare labeling claims with the scope, methods and results of test evidence. |
| Versions and history | Check dates, revisions and changes to identify the current document set. |
Frequently Asked Questions
What should we prepare for an initial discussion?
Product information, intended use, manufacturing details, approvals and available testing evidence.
When can timing be estimated?
After likely classification and material evidence gaps have been reviewed.
MFDS medical-device regulations · MFDS medical-device approval process · Content baseline · Check current requirements for the specific product
Clarify the Korean regulatory pathway for your product.
Attach what you have and we will reply by email after reviewing it. You do not need a complete set of documents.