By Stewart Eisenhart, Emergo Group
Medical devices registered for sale in South Korea are expected to soon have expedited access to the Mexican market.
Emergo Group has learned that Mexican and South Korean regulators have formed an agreement (link in Spanish) that would ease market entry into Mexico for devices holding Korean Ministry of Food and Drug Safety (MFDS) registrations. Similar agreements between Mexican regulator COFEPRIS and the US Food and Drug Administration, Health Canada and Japan’s Pharmaceuticals and Medical Devices Agency are already in place.
Details of the agreement between COFEPRIS and the MFDS have yet to be released. Emergo Group’s sources in Mexico City and Seoul will provide further information once it’s available.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.