GLGlossary
Test report.
A document containing the results of testing that confirms whether a product meets the specified standards and criteria.
Items required for the product type, such as electrical and mechanical safety or performance, are confirmed at a testing body. Which tests are needed can vary depending on the product's characteristics and class. The test items and costs can be reviewed as an estimated range during the preliminary review stage.
Related work & timing
This involves defining the required test items, commissioning a testing institution, and obtaining the test reports. Testing costs can vary considerably depending on the item, so we provide an estimated range at the preliminary review stage.
Basis
- Act on Testing and Inspection in the Food and Drug Industry
- 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.