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 Please help us maintain this list by reporting outdated or missing documents.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

DocumentLanguageNumberPublished
Decreto 3275, 2009es 327508/2009
Decreto 4725, 2005es 472512/2005
Resolution 004816, 2008es 00481612/2008

Specific Guidance Documents

DocumentLanguageNumberPublished
Additional products regulated as medical deviceses Acta 09/201409/17/2014

Additional Information

DocumentLanguageNumberPublished
Deadline to obtain health registration for various products es 500-8060-1312/2013