Register Your Class II Device in Mexico in 90-150 Days
Navigate COFEPRIS's moderate-risk requirements with confidence. We handle technical dossiers, GMP compliance, and local representation.
Free consultation โข No commitment required
90-150
Days to Market
300+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Why Companies Struggle with Mexico Registration
Specialized devices need specialized expertise
Everything Must Be in Spanish
Technical dossiers, labels, instructionsโall documents must be professionally translated. One error can trigger rejection.
Consultants Charge $6,000-$15,000
Traditional regulatory consultants charge premium fees with hidden costs that appear mid-project.
You Need a Local Mexico Presence
COFEPRIS requires a Mexico Registration Holder (MRH). Without one, you cannot legally sell in Mexico.
We Simplify Class II Registration
Pure Global experts know your device category inside out
Deep Category Expertise
Our regulatory specialists prepare COFEPRIS-compliant technical dossiers. We know exactly what COFEPRIS expects.
Technical Documentation Excellence
We review your manufacturing documentation and identify gaps before submissionโavoiding costly rejections.
Proven Registration Track Record
Our systematic approach gets Class II devices registered in 90-150 days. We've done this 300+ times.
Ongoing Compliance Support
As your Mexico Registration Holder, we're not tied to any distributor. Your registration, your control.
How It Works
Free Consultation
Share your device details. We'll confirm classification, review your documentation readiness, and provide an exact quote.
Dossier Preparation
We prepare your complete technical dossierโtranslated, formatted, and organized to COFEPRIS standards.
COFEPRIS Submission & Follow-up
We submit on your behalf, handle all COFEPRIS queries, and keep you updated throughout the review process.
Market Your Device
Receive your COFEPRIS registration. Your Class II device is legally marketable in Mexico for 5 years.
Trusted by Leading MedTech Companies
โPure Global navigated our Class II registration flawlessly. They handled everything from dossier prep to COFEPRIS follow-up. Registered in just 4 months.โ
Dr. Elena Rodriguez
VP Regulatory Affairs, Advanced Diagnostics Corp.
Class II Investment
Complete service, no hidden fees
Starting from
$2,000/year
$6,000-$15,000 with traditional consultantsSave 60-80%
Ready to Register Your Class II Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.