medical device

STED Evaluation

'STED(Summary Technical Documentation) Evaluation

The STED is intended for conformity assessment purpose. The manufacturer or the importer creates the STED(Summary Technical Documentation) to demonstrate to a Regulatory Authority(KFDA) that the subject medical device is in conformity with Essential Principles.

For all medical devices, the manufacturer or the importer is required to conduct conformity assessment according to the Essential Principles before placing the device on market. The STED should need to be reviewed/approved by Regulatory Authority(KFDA) or a Conformity Assessment Body(KTC, etc) before the applicable device is placed on the market.

KTC has been designated STED Conformity Assessment Body by the Commissioner of KFDA.

A person in charge & Contact