Colombian Regulators Now Consider Medical Displays Medical Devices
INVIMA, the Colombian medical device market regulator, has announced that medical displays are now considered Class IIa medical devices subject to registration requirements in the country.
The regulator defines (link in Spanish) displays as any products used medically to reproduce or view medical images. INVIMA announced its new approach to medical displays in February 2016; affected importers and manufacturers will have a six-month period from the announcement date to obtain Class IIa registration in order to continue selling their products as devices in Colombia.
Colombian Class IIa registration entails appointing a Colombia Legal Representative, as well as providing a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG), proof of quality system compliance and test reports to INVIMA for review. How these requirements will impact medical display manufacturers heretofore unaccustomed to the Colombian registration process remains to be seen.