Deadline nears in Korean demand for class I device manufacturer QP
This article was originally published in Clinica
Executive Summary
Manufacturers of Class I medical devices in South Korea are being asked by the Medical Devices Safety Bureau of the Korean Ministry of Food and Drug Safety (MFDS/KFDA) to appoint a quality management representative/qualified person (QP). They have until 29 July 2014 to fill these new posts, the holders of which will be charged with ensuring quality management by manufacturers and importers.