Pure Global
Pure Global
๐Ÿ‡จ๐Ÿ‡ดColombia Class I Medical Device Registration

Register Your Medical Device in Colombia in 1-7 Days

Skip the complexity. We handle everythingโ€”INVIMA notification, translations, compliance. You focus on your business.

See Pricing

Free consultation โ€ข No commitment required

1-7

Days to Market

200+

Devices Registered

60-80%

Cost Savings

5yr

Registration Validity

Colombia Registration Is Complex

Specialized devices need specialized expertise

Language Barrier

All documents must be in Spanish. One mistranslation can delay your approval by months.

High Consultant Fees

Traditional consultants charge $3,000-$8,000 for Class Iโ€”often with hidden fees that appear mid-project.

Unknown Timeline

Without local expertise, companies wait 4+ months for what should take 1-7 days.

The Solution

We Make Colombia Registration Simple

Pure Global experts know your device category inside out

Deep Category Expertise

From classification to INVIMA submissionโ€”we handle the entire process. You just provide your device documentation.

Technical Documentation Excellence

Know exactly what you'll pay upfront. No surprises. No hourly billing. No hidden fees emerging mid-project.

Proven Registration Track Record

Our local Colombia office and streamlined process get your Class I device registered in 1-7 days, not 4+ months.

Ongoing Compliance Support

As an independent CRH, we're not your distributor. Change commercial partners anytime without losing your registration.

How It Works

1

Free Consultation

Tell us about your device. We'll confirm classification and provide an exact quote within 24 hours.

2

We Handle Everything

Send us your documents. We translate, prepare, and submit to INVIMA on your behalf.

3

Start Selling in Colombia

Receive your INVIMA registration number. Your device is legally marketable for 5 years.

Trusted by 300+ Medical Device Companies

Licensed Registration Holder
15+ Years Experience
Category Specialists
Local Office
โ€œPure Global got our Class I device registered in just 45 days. Their transparent pricing saved us thousands compared to our previous consultant.โ€

Andrea Garcia

VP Regulatory Affairs, MedTech Innovations Corp.

Simple, Transparent Pricing

No hidden fees. Know exactly what you'll pay.

Starting from

$2,000/year

$3,000-$8,000 with traditional consultantsSave 60-80%

Ready to Enter the Colombia Market?

Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.

Free consultation No hidden fees Response within 24h
Pure Global

Medical Device Registration Experts โ€ข 30+ Countries โ€ข AI-Powered