INVIMA medical device registration checklist (Colombia, 2026)
Quick answer. In Colombia, medical devices are registered with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) under Decreto 4725 de 2005; Colombia is the one LATAM market where a foreign manufacturer can own the registration directly, appointing a local legal representative; devices split into uncontrolled (Class I and IIa — automatic approval on submission) and controlled (Class IIb and III — INVIMA reviews the dossier before approval); you also need a Colombian importer with a CCAA (storage-and-conditioning capacity certificate); registrations are valid for 10 years.
Classes and pathways
- Uncontrolled (Class I/IIa) — eligible for automatic registration once a complete application is submitted, fast to market.
- Controlled (Class IIb/III) — INVIMA conducts a substantive documentation review before approval, plan for roughly 6–8 months.
Who holds the registration
- A foreign manufacturer may hold the registro sanitario directly, with a local legal/regulatory representative managing the process and interfacing with INVIMA (bioaccess® serves in this role).
- You must identify a Colombian importer holding a CCAA (Certificado de Capacidad de Almacenamiento y Acondicionamiento) before registering, and the representative can help meet this.
Submission checklist
- Local legal representative in Colombia (bioaccess®) and a CCAA-holding importer identified
- Manufacturer quality evidence (ISO 13485, MDSAP where relevant)
- Certificate of Free Sale (CFS) and, where applicable, CE certificate or FDA clearance as reference approval
- Technical documentation (device description and intended use, risk management ISO 14971, design/technical file, and clinical evidence for higher-risk devices)
- Labeling and IFU in Spanish
- Certified Spanish translations where required and official translation for apostilled public documents
- Legalization/apostille of foreign public documents (power of attorney, CFS) done in the country of origin
- UDI-DI and semantic reporting per Resolución 1405 de 2022 — registration holders submit product information (UDI-DI codes from a certified agency) via INVIMA's platform
Indicative timeline
- Uncontrolled (I/IIa) — dossier prepared in a few weeks, approval automatic on submission.
- Controlled (IIb/III) — dossier in a few weeks, INVIMA review ~6–8 months.
- Government fees and translations are billed at cost and bundled into a single quoted number.
Answers to common questions
Do I need a Colombian company to register?
No — the manufacturer can hold the registration, but you need a local legal representative and a CCAA-holding importer; bioaccess® provides the representation and helps arrange the importer.
How long is an INVIMA registration valid?
Ten years, with the UDI/semantic-report obligations maintained.
Is CE marking required?
CE or FDA reference approval supports the file and is expected for many devices; for lines without it we confirm per product whether the home-country approval plus ISO 13485 and CFS is accepted.
Book a 30-min Colombia market-access call · Medical device registration in Latin America: 2026 country-by-country guide
General information as of 2026; INVIMA requirements change and the definitive pathway is confirmed at scoping. bioaccess® provides regulatory representation, not legal advice.