Register Your Immunology Device in Mexico
Immunoassay analyzers, allergy testing, autoimmune diagnosticsโspecialist COFEPRIS registration for immunology IVDs.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Immunology IVDs Face Unique Validation Challenges
Specialized devices need specialized expertise
Assay Complexity
Immunoassays require extensive validationโsensitivity, specificity, cross-reactivity, and interference studies.
Clinical Decision Impact
Autoimmune and allergy diagnostics influence critical treatment decisions. COFEPRIS requires robust clinical correlation data.
Multi-Analyte Systems
Multiplexed immunoassay platforms need validation for each analyte, multiplying documentation requirements.
We Specialize in Immunology Devices
Pure Global experts know your device category inside out
Deep Category Expertise
Immunoassay analyzer and reagent registration
Technical Documentation Excellence
Allergy and autoimmune diagnostic device expertise
Proven Registration Track Record
Multi-analyte platform validation documentation
Ongoing Compliance Support
Clinical correlation study presentation
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 Immunology Device Companies
โOur autoimmune diagnostic portfolio is now available in Mexico. Pure Global's immunology expertise was crucial.โ
Dr. Sophie Laurent
VP Regulatory Strategy, ImmunoTech Diagnostics
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 Immunology Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.