What is a Colombia Registration Holder (CRH) and why do foreign manufacturers need one?

A Colombia Registration Holder (CRH) is the legally mandated in-country representative that submits and maintains your INVIMA registrations. Without a licensed Colombian entity, foreign manufacturers cannot place medical devices or IVDs on the market.

Should I appoint an independent CRH or let my distributor manage INVIMA registrations?

Independent CRHs keep you in control of approvals, while distributor-led registrations create commercial lock-in. Most global manufacturers separate regulatory representation from distribution to avoid losing certificates when sales partners change.

What baseline compliance responsibilities should my CRH manage under Colombian law?

Your CRH must classify your device, prepare the technical dossier, coordinate with a CCAA-certified importer, maintain vigilance reports, and manage renewals every 5-10 years. These tasks are mandated by Decree 4725/2005 and Resolution 1405/2022.

What qualifications define a trustworthy Colombia registration holder?

Prior INVIMA approvals, bilingual regulatory staff, active ISO 13485 quality systems, and transparent references signal a competent CRH. Confirm the team has sector-specific experience and a physical office in Colombia.

How can I assess technology and transparency when comparing CRHs?

Look for digital portals, AI-assisted dossier builders, and real-time status dashboards. Transparency should include published pricing ranges, renewal alerts, and shared KPI reporting so your team can monitor every INVIMA submission.

What red flags signal that a CRH could put my INVIMA approval at risk?

Beware of vendors that refuse to name their regulatory lead, hide importer partnerships, or rely on hourly billing without milestones. Missing renewal reminders, no vigilance process, or slow responses to INVIMA are critical warning signs.

How much should I budget for CRH services and INVIMA submissions?

Expect $2,000-$3,000 per device for INVIMA submissions when working with an independent CRH. Annual representation, importer coordination, and surveillance average $5,000. Renewals are capped at 50% of the original registration cost.

How long do INVIMA approvals take by device class?

Class I and IIa devices receive automatic approval once dossiers are filed, typically 3-4 weeks after submission preparation. Class IIb and III devices undergo INVIMA review lasting 6-8 months, so proactive query management is essential.

What ongoing compliance tasks must be captured in my CRH agreement?

Include vigilance alerts, field safety corrective actions, labeling updates, UDI uploads, importer audits, and annual performance reviews. Documented responsibilities protect you during INVIMA inspections and internal quality audits.

How does Pure Global support multi-market expansion from a Colombia base?

Pure Global’s “Single Process, Multiple Markets” model replicates Colombia technical files across 30+ countries. Once INVIMA approves your dossier, our subsidiaries adapt the content for other LATAM and global authorities to accelerate market entry.

What Colombia-specific expertise does Pure Global bring?

Our Bogotá-based Pure Global team leads bilingual submissions, coordinates certified importers, and tracks regulatory changes from INVIMA. Pure Global pairs local insight with AI tools that analyze 5M+ regulatory documents.

How do I get started with Pure Global's Colombia CRH service?

Contact Pure Global via the Colombia market page or email info@pureglobal.com. We deliver a readiness review, confirm classification, align on pricing, and launch dossier preparation with importer coordination in under two weeks.

Choose a Colombia Registration Holder (CRH) FAQ - Updated October 2025

How To 7 Objective Criteria for Selecting Your Colombia CRH. Expert guidance by Pure Global regulatory specialists

INVIMA Compliance

CRH Selection Guide

Market Entry Strategy

Pure Global: Independent Colombia Registration Holder

Pure Global blends on-the-ground INVIMA expertise with AI-enabled document automation, transparent pricing, and importer coordination to keep you in control of your registrations.

Our Colombia regulatory specialists deliver bilingual support, manage legal representation, and connect you with certified CCAA importers. Every project aligns with Resolution 1405/2022 and Decrees 4725/2005 and 3770/2004 for seamless approvals.

✓ Transparent Pricing

$2K-$3K per device including government fees; renewals capped at 50%.

✓ AI + Local Experts

AI dossier builder plus Bogotá-based consultants for faster responses.

✓ Multi-Market Scale

Single process extends to 30+ markets through Pure Global subsidiaries.

Colombia Device Market

$1.5B

Medical device market size with 5.7% CAGR (2024 data)

Foreign Supply Share

80%+

Share of devices imported by international manufacturers

Registration Validity

5-10 Years

INVIMA renewals: 10 years (MD), 5 years (Class III IVD)

Pure Global Advantage

AI + Local Team

Bilingual Pure Global specialists manage INVIMA submissions

Frequently Asked Questions

On This Page

Colombia Registration Holder Fundamentals

Evaluating Potential CRH Partners

Costs, Timelines, and Compliance Expectations

Pure Global's Colombia Advantage

Quick Resources

All Colombia Regulations Colombia How-To Guides Pure Global Colombia Services

Key Dates & Milestones

Guide UpdatedOctober 2025

Resolution 1405/2022UDI & Vigilance Active

Pure Global Colombia ServicesActive Now

Colombia Market Snapshot

MD Market Size

$1.5B

IVD Market Size

$0.29B

MD CAGR

5.7%

Aging Population

14.2%

80%+ of devices are imported, creating strong demand for independent CRHs with importer networks.

Pure Global Colombia Readiness

Why teams choose Pure Global:

✓ Bilingual Bogotá-based regulatory staff
✓ Published pricing: $2K-$3K submissions
✓ AI-enabled dossier automation
✓ Certified CCAA importer coordination
✓ Vigilance + UDI support (Resolution 1405/2022)

Ready to launch? info@pureglobal.com

Note: This FAQ guide provides general information about regulatory requirements and should not be considered as legal advice. Regulations are subject to change. Always consult with qualified regulatory professionals for specific guidance.

Last updated: October 2025 | Based on Choose a Colombia Registration Holder (CRH) official documentation