By Stewart Eisenhart, Emergo Group

Egyptian medical device market regulators at the Central Administration of Pharmaceutical Affairs (CAPA) will soon require the latest version of the ISO 13485 standard for quality system compliance, Emergo Group’s Cairo office has learned.

Medical device manufacturers selling in Egypt will have a six-month grace period before CAPA begins requiring ISO 13485:2012 compliance for registrations and importation.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.