Colombia medical device registration timeline

Source-linked clocks

Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) classification system.

4 pathways4 of 4 clocks verifiedvalidity 10 yearsMDSAP not acceptedreviewed 2026-08-30normograma.invima.gov.co

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class I(Notification (NSO)) Decreto 4725/2005 Arts. 21-22 (as amended by Decreto 582/2017): once documents are complete, INVIMA issues the automatic registro administrative act within 2 working days (Classes I and IIa)	2 working days	1-2 months	—	Verified
Class IIa(Registration (NSO)) Decreto 4725/2005 Arts. 21-22: automatic registro administrative act within 2 working days once documents are complete (Classes I and IIa)	2 working days	1-2 months	2-3 months	Verified
Class IIb(Registration (RSO)) Decreto 4725/2005: 90 working days for registro sanitario evaluation once documents are complete (Classes IIb and III)	90 working days	6-12 months	4-6 months	Verified
Class III(Full Registration (RSO)) Decreto 4725/2005: 90 working days for registro sanitario evaluation once documents are complete (Classes IIb and III)	90 working days	9-18 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Colombia Medical Device Registration Process

Step-by-step INVIMA registration process. Total estimated timeline: 1-2 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by INVIMA. Appoint a Colombia Registration Holder (CRH).

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to INVIMA including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

INVIMA reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

2 working days

In-depth technical assessment of device safety and performance. INVIMA may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, INVIMA issues Colombia market authorization certificate.

Summary: The Colombia medical device registration process through Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Expedited pathways

Homologación for reference countries (Decreto 3275/2009)None — the Decreto 4725/2005 clocks are unchanged; the saving is in dossier assembly

Colombia does not run a separate reliance queue. What a reference-country approval buys is the right to skip specific numerals of the Formato Único: for Class I and IIa the technical studies and analytical checks, the sterilisation method and the disposal method; for Class IIb those three plus the clinical studies. Class III is outside the homologation and has to file all twenty numerals.

Eligibility: Device originates from a reference country: the European Community, the United States, Canada, Japan, Australia, or a country with a mutual recognition agreement, Risk class I, IIa or IIb — Class III devices file the complete Formato Único regardless of origin

Prior approval recognition

FDA 510(k)Reference-country origin under Decreto 3275/2009, homologating technical studies, sterilisation method and disposal method for Class I/IIa and additionally clinical studies for Class IIbNone published

EU CE MarkReference-country origin under Decreto 3275/2009None published

Health CanadaReference-country origin under Decreto 3275/2009None published

Japan MHLWReference-country origin under Decreto 3275/2009None published

Australia TGAReference-country origin under Decreto 3275/2009None published

ANVISA (Brazil)Brazil is not on the INVIMA reference-country list and there is no device mutual recognition agreement in forceNone

Key requirements

Colombia Registration Holder (CRH) - mandatory for foreign manufacturers
Spanish labeling and IFU
Free Sale Certificate
GMP certificate (ISO 13485)
Technical documentation
Post-registration: modifications to automatic registries are decided within 2 days; evaluation-type modifications carry a one-time information request with a 90-day window

Primary regulator sources

normograma.invima.gov.co · Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22) invima.gov.co · INVIMA medical devices and biomedical equipment procedures — Formato Único numerals by risk class and the Decreto 3275/2009 homologation for reference countries

Reviewed 2026-08-30. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against INVIMA publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:colombia:class-i