Register Your Class IIa Device in Colombia in 1-7 Days
Fast-track approval for low-medium risk devices. Automatic INVIMA approval means you can start selling in Colombia within days.
Free consultation โข No commitment required
1-7
Days to Market
200+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Why Companies Struggle with Colombia Registration
Specialized devices need specialized expertise
Everything Must Be in Spanish
Technical dossiers, labels, instructionsโall documents must be professionally translated. One error can trigger rejection.
Consultants Charge $4,000-$10,000
Traditional regulatory consultants charge premium fees even for automatic approval processes.
You Need a Local Colombia Presence
INVIMA requires a Colombia Registration Holder (CRH). Without one, you cannot legally sell in Colombia.
We Fast-Track Your Class IIa Registration
Pure Global experts know your device category inside out
Deep Category Expertise
Class IIa devices receive immediate approval from INVIMAโno waiting for technical review. We handle the notification process.
Technical Documentation Excellence
We prepare all required documents in Spanish, ensuring your submission meets INVIMA's automatic approval criteria.
Proven Registration Track Record
Our streamlined process gets your Class IIa device registered and ready to sell in just 1-7 days.
Ongoing Compliance Support
As your Colombia Registration Holder, we're not tied to any distributor. Your registration, your control.
How It Works
Free Consultation
Share your device details. We'll confirm Class IIa classification and provide an exact quote within 24 hours.
Document Preparation
We prepare your complete notification packageโtranslated, formatted, and ready for automatic approval.
INVIMA Notification
We submit your notification to INVIMA. Automatic approval means no waiting for technical review.
Start Selling Immediately
Receive your INVIMA registration. Your Class IIa device is legally marketable in Colombia for 5 years.
Trusted by Leading MedTech Companies
โPure Global got our Class IIa device registered in just 5 days. The automatic approval process was seamless, and their pricing was transparent from day one.โ
Dr. Felipe Ramirez
VP Regulatory Affairs, Diagnostic Solutions Ltd.
Class IIa Fast-Track
Automatic approval, no hidden fees
Starting from
$2,000/year
$4,000-$10,000 with traditional consultantsSave 60-80%
Ready to Fast-Track Your Class IIa Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.