Register Your Clinical Chemistry Device in Mexico
Analyzers, reagents, and diagnostic systemsโstreamlined COFEPRIS registration for your clinical chemistry products.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
IVD Registration Has Its Own Complexities
Specialized devices need specialized expertise
IVD-Specific Regulations
Clinical chemistry devices follow Mexico's IVD framework. Different rules, different documentation.
Reagent + Analyzer Systems
Registering integrated systems requires coordinating multiple product dossiers and compatibility data.
Frequent Reagent Updates
New reagent formulations require COFEPRIS amendments. Managing ongoing compliance is a continuous challenge.
We Specialize in Clinical Chemistry Devices
Pure Global experts know your device category inside out
Deep Category Expertise
IVD-specific regulatory pathway expertise
Technical Documentation Excellence
Integrated analyzer and reagent system registration
Proven Registration Track Record
Performance data presentation for accuracy and precision
Ongoing Compliance Support
Ongoing amendment management for reagent updates
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 Clinical Chemistry Companies
โPure Global handles all our clinical chemistry registrations in Mexico. They know the IVD regulations inside out.โ
Sarah Mitchell
Director of Regulatory, DiagnoLab 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 Clinical Chemistry Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.