May 30, 2014
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 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.
Mexican medical device regulator COFEPRIS has extended its Equivalency Agreement granting expedited reviews for some medical device
Mexico’s medical device market regulator COFEPRIS has formally published a new list of medical devices that no longer require registration and those that qualify for new Class Ia status in th
Medical devices and IVD products able to pass muster with the US FDA and Health Canada may now enjoy de facto access to Mexico as well thanks to recent regulatory reforms. The Mexican Health Author