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 Please help us maintain this list by reporting outdated or missing documents.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.
| Document | Language | Number | Published |
|---|---|---|---|
| Decreto 3275, 2009 | es | 3275 | 08/2009 |
| Decreto 3770, 2004 | es | 3770 | 11/2004 |
| Decreto 4725, 2005 | es | 4725 | 12/2005 |
| Resolution 004816, 2008 | es | 004816 | 12/2008 |
| Document | Language | Number | Published |
|---|---|---|---|
| Additional products regulated as medical devices | es | Acta 09/2014 | 09/17/2014 |
| Document | Language | Number | Published |
|---|---|---|---|
| Deadline to obtain health registration for various products | es | 500-8060-13 | 12/2013 |
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
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