GLGlossary
Classification (device class).
A grouping of medical devices by risk level. The higher the class, the deeper the verification process.
Because the class a product is assigned to can set the direction of the entire subsequent procedure, classification is the first step in preparing for approval. Even products that look similar can be classified differently depending on how they work and their intended use. The exact classification of a specific product can be determined after reviewing its characteristics.
Related work & timing
As the first step in preparing for approval, the product specifications are reviewed to determine its class. We can check the classification for you free of charge during the preliminary review stage.
Basis
- Medical Devices Act — Article 3 (Classification and Designation)View source →
- Regulation on Medical Device Items and Classification by Item (MFDS Notification)
The references shown are for guidance; confirm the exact, current requirements against the source text and through consultation.
The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.
Other terms
← Back to glossary- Regulatory approval
- Technical documentation
- KGMP (manufacturing and quality management standard)
- Test report
- Clinical evaluation
- Import and manufacturing business
- Post-market management
- Certification body / review body
- Labeling and advertising
- ISO 13485
- Manufacturer and manufacturing site
- Identical, equivalent, and improved devices
- UDI (Unique Device Identification)
- CB test report
- Validation
- Risk management