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 Please help us maintain this list by reporting outdated or missing documents.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...
Affirmations of Compliance Codes (AofC Codes)
According to informal discussions with the FDA, proper use of AofC codes can reduce the Customs processing time from several days to a matter of minutes.
|DEV||Device Foreign Manufacturer Registration Number||Establishment Registration number|
|DFE||Device Foreign Exporter Registration Number||Establishment Registration number|
|DII||Device Initial Importer Registration Number||Establishment Registration number|
|IDE||Investigational Device Exemption Number||IDE number|
|IFE||Import for Export||n/a|
|IRC||Impact Resistance Lens Certification||n/a|
|LST||Device Listing Number||Device listing number from FURLS|
|LWC||Lead Wire or Patient Cable||n/a|
|MDL||Model Number||Manufacturer's model number|
|PMA||Device Premarket Approval Number||PMA number|
|PMN||Device Premarket Notification Number (510(k))||510(k) number|