Colombia Regulatory Framework Medical Device registration

Colombian Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Colombian market:

Major Regulations

Regulations Year
Decreto 3275, 2009 2009
Decreto 3770, 2004 2004
Decreto 4725, 2005 2005
Resolution 004816, 2008 2008

Specific Guidance Documents

Document Year
Additional products regulated as medical devices 2014

Additional Information

Document Year
Deadline to obtain health registration for various products 2013

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