Register Your Pathology Device in Mexico
Tissue processors, microtomes, staining systems, digital pathologyโcomprehensive COFEPRIS registration for pathology labs.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Pathology Equipment Classification Varies Widely
Specialized devices need specialized expertise
Device Diversity
From simple microtomes to AI-powered digital pathologyโpathology spans multiple risk classes and pathways.
Software as Medical Device
Digital pathology and AI-assisted diagnosis face Mexico's evolving SaMD regulations.
Reagent Integration
Staining systems with proprietary reagents require coordinated device and IVD registration strategy.
We Specialize in Pathology Equipment
Pure Global experts know your device category inside out
Deep Category Expertise
Tissue processing equipment registration
Technical Documentation Excellence
Digital pathology and AI diagnostic system expertise
Proven Registration Track Record
Staining system and reagent registration
Ongoing Compliance Support
Laboratory automation device 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 Pathology Device Companies
โPure Global registered our digital pathology platform in Mexico. They understood both device and software requirements.โ
Dr. Catherine Ross
VP Global Regulatory, DigiPath Solutions
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 Pathology Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.