GLGlossary
Clinical evaluation.
The process of compiling and evaluating materials that clinically support a product's safety and performance.
In some cases existing literature and data can serve in place of it, and depending on the product, clinical trial data may be needed. Whether it is needed and to what extent can vary depending on the product type, class, and product characteristics. The level required for a specific product can be determined through a review of the materials.
Related work & timing
For items that require clinical evaluation (mainly Class 3 and 4), the relevant data is organized and evaluated. Where a clinical trial is required, the overall timeline may be extended significantly.
Basis
- Medical Devices Act — Article 10 (Clinical Trials)View source →
- Regulation on Approval of Clinical Trial Plans for 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.