Registration validity
approval.registration-validity-years
- Years
10
- StartsFrom
administrative-act-issuance
INVIMA · structured requirements
🇨🇴 Colombia medical device regulatory data
Explore the medical device requirements currently available for Colombia, organized by topic and linked to official sources.
12 facts6 dimensions3 official sourceslatest verification 2026-08-24
Approval validity & renewal
What expires, what is retained periodically, and when must renewal start?
Fact-level verified
Renewal filing lead time
approval.renewal-lead-months
- MonthsBeforeExpiry
3
Authorization duration
authorization.duration
- Type
Fixed Term
- Description
10 years
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Expiry or lapse consequence
authorization.lapse
Expired registration does not authorize continued new placement.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Renewal or maintenance
authorization.renewal
Renewal follows the required legal and technical procedure before expiry.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Change control
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
New-application triggers
change.new-application-triggers
- significant change affecting safety/effectiveness
- specified design/material/energy/manufacturing changes
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Significant-change boundary
change.significant-change-outcome
An existing registration or marketing permit cannot be modified when a significant device change may affect safety or effectiveness, including specified design, material, energy-source, or manufacturing-process changes.
Device definition & scope
Is the product a device, IVD, accessory, software, or borderline product locally?
General medical-device scope
scope.general-medical-devices
Decree 4725 regulates medical devices for human use and excludes IVD reagents and custom-made devices from this decree's general scope.
Dossier requirements
Which evidence, local deltas, formats, and signatures are required?
Technical-evaluation dossier
dossier.technical-evaluation
Article 18 defines the technical-evaluation information and evidence for devices that are not controlled-technology biomedical equipment.
Economic-operator roles
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Local market-entry role
market-entry.local-role
- Archetype
Marketing Authorization Holder Or Registrant
- Name
Colombian registration holder
- Required For Foreign
yes
- Registration Relation
Holds INVIMA Registration
- Importer Relation
Can Be Added Or Changed As Modification
- Distributor Relation
Can Be Separate
- Combination
allowed
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Representative or holder change
market-entry.representative-change
- Path Code
Holder Assignment Modification
- Fresh Registration
Usually No For Valid Assignment
- Minimum Handover
- assignment
- manufacturer relationship documents
- registration dossier
- importer list
- complaints/vigilance/recalls
- Spanish labels
- Notes
Holder assignment and importer changes are distinct modification events.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Automatic registration classes
registration.automatic-classes
- I
- IIa
Conditions
- The device is not controlled-technology biomedical equipment.
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