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Product Registration
Prepare notification, certification or approval evidence for the product's class and review pathway.
When a review helps
Check consistency across evidence and labeling
Respond to review questions
When is this service useful?
The administrative application, technical documentation and test evidence must tell the same product story. We focus on consistency across intended use, materials and construction, performance, test specifications and labeling.
Key areas of review
Application preparation
Organize product names, models, intended use, materials and construction.
Technical documentation
Structure safety, performance and test evidence for Korean requirements.
Authority responses
Analyze questions and coordinate evidence-based answers with the manufacturer.
Prepare for your review
- Product description, labeling and IFU
- Design, construction and material information
- Test reports
- Risk-management and performance evidence
How We Work
Receive evidence
Collect prior approvals and technical information.
Structure the dossier
Reorganize the evidence into the Korean application and technical-document format.
File and manage review
Coordinate submission and authority questions.
Confirm approval consistency
Check the approved particulars, labeling and imported models.
Check consistency across documents
Compare names, models, intended use and performance across technical files, test evidence and labeling; identify discrepancies.
The specific scope and deliverables are agreed after product and evidence review.
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
CONSULTATION
Start a consultationClarify 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.