The 2-day automatic lane
Class I/IIa: act within 2 business days of a complete file. Class IIb/III: 90 business days — with 90 days to answer info requests.
Free field guide · PDF
Colombia INVIMA Medical Device Registration2026 Field Guide
The 2-day automatic lane, the 90-day clock, and the 2026 UVB fee schedule — with dossier and renewal discipline.
- Class I/IIa lane
- 2 days
- Class IIb/III clock
- 90 days
- 2026 base fee
- COP 3.9M
Sourced from INVIMA 2026 guidance and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — INVIMA 2026 guidance and verified 2026 publications.
The 2026 UVB fee schedule
2026 Resolución 2025067543: Class I/IIa ≈ COP 3.9M, IIb/III ≈ COP 4.4M — priced in UVB, consultancy billed separately.
Dossier discipline and renewal
Apostilled paperwork, full technical file, foreign holders allowed, and renewals 3 months before expiry.
Sources & scope
- artixio.com, INVIMA medical device registration in Colombia.
- spiamericas.com, requisitos de dispositivos médicos — Colombia (2026).
- massdevice.com (Emergo Group), INVIMA translation and grouping rules.
- meddeviceonline.com, INVIMA clinical-trial process context.
This guide is market-access intelligence, not regulatory or legal advice. INVIMA timelines, fee schedules, and classification practice are product-specific — professional review is required before business use.
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