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) Notification-based, minimal review	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) Reliance pathway available for recognized approvals	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) Incomplete dossiers are rejected at filing (not suspended) Technical documentation review required	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) Incomplete dossiers are rejected at filing (not suspended) Clinical evidence mandatory Class III sits outside the Decreto 3275/2009 homologation, so a reference-country approval removes nothing: all twenty numerals of the Formato Único have to be filed whatever the origin	90 working days	9-18 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

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