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Device Classification & Regulatory Strategy
From Korean classification to the order of execution, set the market-entry pathway first.
When a review helps
Choose the Korean pathway and its order
Prioritize testing and documentation
When is this service useful?
We confirm the Korean product category, class and notification, certification or approval pathway from the intended use and characteristics, then plan the order of testing, technical documentation, KGMP and registration from the gap between your evidence and Korean requirements.
Key areas of review
Intended use and characteristics
Review intended use, operating principles, configuration and components.
Korean category and class
Assess the category, class and authorization pathway against classification criteria.
Evidence and gap analysis
Compare available evidence with Korean requirements and identify what is still needed.
Execution sequence
Assess which testing, translation, KGMP and filing work can run in parallel and set the order.
Prepare for your review
- Product description and intended use
- Manufacturer information
- Test evidence and overseas approvals
- Target launch timing
What you receive after review
Classification summary
The proposed category and class with the supporting reasoning.
Evidence to complete
Documents and risk items that need confirmation or preparation.
Execution roadmap
A plan with prerequisite and parallel work and the decision points.
Connect classification with the execution plan
Use the product description and intended use to resolve classification questions and evidence gaps, then turn them into testing, documentation and a submission plan.
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.