GLGlossary
Identical, equivalent, and improved devices.
A way of classifying your device according to how closely it resembles a device that has already been approved in South Korea.
If the intended use, principle of operation, raw materials, performance, test specifications, and method of use are all equivalent to an already-approved device, it is treated as an equivalent device; if the intended use and principle of operation are the same but performance or method of use differs, it is an improved device; and if those differ too, it is treated as a new device. The classification you land in can change the test data you have to submit and the depth of the review considerably. The criteria are set item by item, so the conclusion can differ from product to product.
Related work & timing
This is done at the very start of building a registration strategy, by searching approved devices and judging where yours sits. That judgment sets the overall timeline and the direction of the documentation to be prepared.
Basis
- 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- Regulatory approval
- 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
- UDI (Unique Device Identification)
- CB test report
- Validation
- Risk management