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Intellectual Property Bulletin

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COLOMBIA

PROPOSED LEGISLATION SEEKING TO SIMPLIFY THE RENEWAL AND AMENDMENT OF MARKETING AUTHORIZATIONS OF MEDICAL DEVICES AND IN VITRO DIAGNOSTIC REAGENTS

The Health Ministry has submitted a proposed legislation aiming to simplify the renewal and amendment of marketing authorizations for medical devices for human use in classes IIb and III, and in vitro diagnostic reagents.

 

Said legislation proposes to include a non-extendible deadline for the Colombian Regulatory Authority to issue marketing authorizations for the mentioned medical devices and diagnostic reagents.

The drafts are in the observations and comments stage, before approval and final publication.