GLGlossary
Technical documentation.
A set of documents showing that a product was designed and manufactured to standard.
It contains an overview-level account of the product's structure, intended use, and performance. Which items are required, and to what depth, can vary by device type and class. The detailed makeup required for a specific product can be advised through consultation.
Related work & timing
A core part of preparing for approval or certification, the technical file is drafted and organized to match the review points for each item. It tends to be one of the more time-consuming parts of the documentation stage.
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.