Egypt creates labelling headache for device firms:
This article was originally published in Clinica
Executive Summary
Medical device manufacturers in Europe are angry that the Egyptian regulatory authorities have created a barrier to trade. They are the only regulatory authorities to have introduced - and without prior warning - a law which requires manufacturing dates to feature on medical device labelling. Without the manufacturing date, the authorities say will not approve any new or amended registration applications. The European medical device industry association, Eucomed, is seeking comments; in the meantime, individual manufacturers have been seeking an exemption on the grounds that Egypt is the only authority with this requirement.