GLGlossary
Regulatory approval.
The process of proving to the regulator that a device is safe and its performance is verified, and obtaining permission, before it can be sold.
The procedure and the time it takes can vary depending on which class the device falls under. The documents you prepare consist of materials that demonstrate the product's safety and performance. A regulatory consultant's role is to organize the procedure and materials and prepare the regulator response together with you.
Related work & timing
Depending on the class (1 to 4), products fall under notification, certification, or approval, and the timeline from preparation to issuance can vary by class. You can review the expected procedure for each class in the pathway guide on the home page.
Basis
- Medical Devices ActView source →
- Regulation on Approval, Notification, and Review of Medical Devices (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- Classification (device class)
- 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