Register Your GI/Urology Device in Colombia
Endoscopes, stents, catheters, dialysis equipmentโcomprehensive INVIMA registration for gastroenterology and urology products.
Free consultation โข No commitment required
60-180
Days to Market
500+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
GI/Urology Covers Diverse Device Categories
Specialized devices need specialized expertise
Invasive Device Requirements
GI stents, urological devices, and dialysis equipment face strict biocompatibility and sterility requirements.
Endoscope Complexity
Flexible endoscopes require reprocessing validation, optical performance testing, and durability data.
Fluid Contact Devices
Dialysis and urological devices in contact with blood or body fluids need extensive extractables/leachables data.
We Specialize in GI/Urology Devices
Pure Global experts know your device category inside out
Deep Category Expertise
GI endoscope and accessory registration
Technical Documentation Excellence
Urological catheter and stent expertise
Proven Registration Track Record
Dialysis equipment registration
Ongoing Compliance Support
Reprocessing and sterilization validation documentation
How It Works
Free Consultation
Share your device details. We'll confirm classification, assess your documentation, and provide an exact quote.
Expert Dossier Preparation
Our regulatory specialists prepare your complete submission with deep specialty knowledge.
Submission & Management
We submit on your behalf and manage the entire review process, including deficiency responses.
Market Your Device
Receive your registration. Your device is legally marketable for 10 years.
Trusted by Leading GI/Urology Device Companies
โPure Global registered our complete flexible endoscope line in Colombia. Their understanding of reprocessing requirements was invaluable.โ
Dr. Chen Wei
VP Regulatory, EndoVision Medical
Transparent Pricing
Complete service, no hidden fees
Starting from
Starting from $2,000/year
Based on device class and complexitySave 60-80%
Ready to Register Your GI/Urology Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.