Register Your Radiology Device in Mexico
X-ray, CT, MRI, ultrasound, nuclear medicineโspecialist COFEPRIS registration for diagnostic imaging equipment.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Imaging Equipment Faces Extensive Technical Review
Specialized devices need specialized expertise
Radiation Safety
X-ray and CT devices require comprehensive radiation safety documentation and shielding specifications.
Image Quality Validation
Diagnostic imaging devices need extensive image quality, resolution, and artifact documentation.
Software Integration
Modern imaging with AI and advanced processing requires software validation per IEC 62304.
We Specialize in Radiology Equipment
Pure Global experts know your device category inside out
Deep Category Expertise
X-ray and CT system registration with radiation safety documentation
Technical Documentation Excellence
MRI and ultrasound device expertise
Proven Registration Track Record
Nuclear medicine equipment registration
Ongoing Compliance Support
PACS and imaging software registration
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 Radiology Equipment Companies
โPure Global registered our CT scanner line in Mexico. Their understanding of radiation safety requirements was excellent.โ
Dr. Klaus Schmidt
Director Regulatory Affairs LATAM, ImagingTech 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 Radiology Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.