Register Your Class IIb Device in Colombia in 6-8 Months
Navigate INVIMA's full technical review for medium-high risk devices. We handle complex dossiers, GMP compliance, and expert follow-up.
Free consultation โข No commitment required
6-8
Months to Market
200+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Why Class IIb Registration Is Challenging
Specialized devices need specialized expertise
Full Technical Review Required
Class IIb devices undergo rigorous INVIMA review. Every technical detail must be perfect to avoid rejection cycles.
Consultants Charge $8,000-$20,000
Traditional regulatory consultants charge premium fees for the extended review process with hidden costs that appear mid-project.
Complex GMP Requirements
INVIMA demands comprehensive manufacturing documentation and GMP compliance evidence for medium-high risk devices.
We Navigate Class IIb Complexity
Pure Global experts know your device category inside out
Deep Category Expertise
Our regulatory specialists prepare comprehensive INVIMA-compliant technical dossiers. We know exactly what reviewers expect.
Technical Documentation Excellence
We review your manufacturing documentation and identify gaps before submissionโavoiding costly rejections and delays.
Proven Registration Track Record
Our systematic approach handles INVIMA queries and deficiency responses to keep your registration on track through the 6-8 month process.
Ongoing Compliance Support
As your Colombia Registration Holder, we're not tied to any distributor. Your registration, your control.
How It Works
Comprehensive Assessment
Share your device details. We'll confirm Class IIb classification, assess documentation gaps, and provide an exact quote and timeline.
Complete Dossier Development
We prepare your full technical dossierโclinical data, risk analysis, GMP evidenceโtranslated and organized to INVIMA standards.
INVIMA Submission & Expert Follow-up
We submit on your behalf and manage the entire review process, responding to all INVIMA queries strategically.
Market Authorization
Receive your INVIMA registration certificate. Your Class IIb device is legally marketable in Colombia for 5 years.
Trusted for Complex Technical Reviews
โPure Global expertly navigated our Class IIb registration through INVIMA's full technical review. They managed every query and kept us on track. Approved in 7 months.โ
Dr. Maria Santos
VP Regulatory Affairs, Advanced Diagnostics Inc.
Class IIb Expert Service
Complete technical review support
Starting from
$3,000/year
$8,000-$20,000 with traditional consultantsSave 60-80%
Ready to Register Your Class IIb Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.