Colombia Medical Device Regulations

All Colombia medical device regulations listed below are in PDF format. Please help us maintain this list by reporting outdated or missing documents. If you need help determining the regulatory requirements for your medical device in Colombia, you may be interested in our custom regulatory strategy reports for Colombia.

Major Regulations
Document Number Published Language
Download Decreto 3770, 2004 3770 11/2004 Spanish
Download Decreto 3275, 2009 3275 08/2009 Spanish
Download Decreto 4725, 2005 4725 12/2005 Spanish
Download Resolution 004816, 2008 004816 12/2008 Spanish
Specific Guidance Documents
Document Number Published Language
Download Additional products regulated as medical devices Acta 09/2014 09/17/2014 Spanish
Additional Information
Document Number Published Language
Download Deadline to obtain health registration for various products 500-8060-13 12/2013 Spanish