This guideline for polypropylene suture was prepared to help the writing of the technical documentation and subsequent approval.
Polypropylene suture is a non-absorbable type of suture used for approximating and ligating soft tissue.
Main content of this guideline includes:
- medical equipment approval authorization process
- approval and technical requirement items, and
- examples of technical requirements.
MFDS Evaluation stated that through this publication of guideline, they hope to increase the understanding of how to write approval/technical writing and increase the speed for the approval process.
The link to the original publication can be found here on the MFDS website (in Korean).