Register Your Microbiology Device in Mexico
Culture systems, identification platforms, susceptibility testingโcomprehensive COFEPRIS registration for microbiology.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Microbiology Diagnostics Need Extensive Validation
Specialized devices need specialized expertise
Organism Coverage
Identification systems must demonstrate performance across hundreds of organismsโeach requiring validation data.
Susceptibility Testing
AST devices need correlation with reference methods and validation against Mexican resistance patterns.
Rapid Test Complexity
Rapid molecular tests for infectious diseases face rigorous scrutiny on sensitivity and specificity.
We Specialize in Microbiology Devices
Pure Global experts know your device category inside out
Deep Category Expertise
Automated identification system registration
Technical Documentation Excellence
Antimicrobial susceptibility testing device expertise
Proven Registration Track Record
Culture media and preparation device registration
Ongoing Compliance Support
Rapid molecular diagnostic 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 Microbiology Device Companies
โOur microbiology identification system is registered in Mexico thanks to Pure Global's deep IVD expertise.โ
Dr. Patricia Hernandez
Director Regulatory Affairs, MicroID Systems
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 Microbiology Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.