This guideline for pulse oximeters was prepared to help the writing of the technical documentation and subsequent approval.
pulse oximeters are commonly used to measure the concentration of oxygen in the blood.
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).