Colombian Regulators: Medical displays will be considered as Class IIa medical devices
According to the Colombian medical device market regulator, medical displays will be considered as Class IIa medical devices subject to registration requirements in the country. As per INVIMA six-month period of time from the announcement date will be given to affected importers and manufacturers to obtain Class IIa registration in order to continue selling their products as devices in Colombia. Colombian Class IIa registration will appoint a Colombia Legal Representative, as well as it will provide a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG), proof of quality system compliance and test reports to INVIMA for review.
(Image Courtesy: medicaldisplaysforless.com)