Posts tagged FAQ
Frequently Asked Questions About Medical Device INVIMA Regulatory Registration, Legal Representation, and Importer of Record in Colombia

Colombia's medical device market is regulated by the National Food and Drug Surveillance Institute (INVIMA). In order to market your device in Colombia, you must obtain sanitary registration from INVIMA.

INVIMA requires that your medical device is approved in a GHTF-founding member country (i.e., Australia, Canada, European Union, Japan, and the United States of America) or from a country that has an existing regulatory agreement of mutual recognition with Colombia.

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