Register Your High-Risk Device in Colombia in 6-12 Months
Class III devices require clinical evidence and rigorous review. We guide you through INVIMA's most demanding pathway.
Free consultation โข No commitment required
6-12
Months to Market
200+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Class III Is INVIMA's Most Rigorous Pathway
Specialized devices need specialized expertise
Clinical Evidence Required
INVIMA demands clinical data proving safety and efficacy. Insufficient evidence means rejection or lengthy delays.
Extensive Technical Review
Every aspect of your device is scrutinizedโdesign, manufacturing, sterilization, biocompatibility, and more.
High Rejection Risk
Without expert preparation, Class III submissions face frequent deficiency letters and rejection cycles.
We Navigate Class III Complexity
Pure Global experts know your device category inside out
Deep Category Expertise
We help you compile and present clinical evidence that meets INVIMA's standardsโavoiding rejection cycles.
Technical Documentation Excellence
Our team prepares comprehensive documentation covering every INVIMA requirement for high-risk devices.
Proven Registration Track Record
When INVIMA requests additional information, we respond strategically to keep your registration on track.
Ongoing Compliance Support
Our Colombia office stays current on INVIMA's evolving requirements and reviewer expectations.
How It Works
Comprehensive Assessment
We evaluate your device, existing documentation, and clinical data. You'll receive a detailed gap analysis and timeline.
Dossier Development
Our regulatory experts compile your technical dossierโclinical summaries, risk analysis, and all supporting evidence.
Strategic Submission
We submit to INVIMA and manage the entire review process, including deficiency responses and reviewer communications.
Market Authorization
Receive your INVIMA registration certificate. Your Class III device is approved for sale in Colombia for 5 years.
Trusted for the Most Complex Registrations
โOur Class III implantable device seemed impossible to register in Colombia. Pure Global's team made it happen in 10 months. Their clinical strategy was invaluable.โ
Dr. Carolina Mendez
VP Regulatory Affairs, Surgical Systems International
Class III Investment
Expert support for high-risk devices
Starting from
$3,000/year
$12,000-$35,000 with traditional consultantsSave 60-80%
Ready to Register Your Class III Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.