About Monitoring Center
In Korea, based on the Medical Devices Act article 31 (Control of Adverse Effects), when device handler discovers any case or risk of death or occurrence of a serious adverse effect on human health while in use, he/she shall immediately report such discovery to the Minister of Food and Drug Safety and shall retain the records thereof.
The monitoring center is designated and operated by National Institute of Medical Device Safety Information (NIDS) for the purpose of establishing a medical device safety management system through active monitoring and reporting activation of safety information by medical institutions and preventing damage to patients.
The duties of the Center shall be as follows:
- 1. Collecting and reporting of medical devices safety information (adverse events) in each institution
- 2. Holding the steering committee of the monitoring center, technical seminars and conducting intensive projects
- 3. Education and guidance to promote reporting of medical device safety information