Register Your Medical Device in Mexico in 30-60 Days
Skip the complexity. We handle everythingโCOFEPRIS notification, translations, compliance. You focus on your business.
Free consultation โข No commitment required
30-60
Days to Market
300+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Mexico Registration Is Complex
Specialized devices need specialized expertise
Language Barrier
All documents must be in Spanish. One mistranslation can delay your approval by months.
High Consultant Fees
Traditional consultants charge $3,000-$8,000 for Class Iโoften with hidden fees that appear mid-project.
Unknown Timeline
Without local expertise, companies wait 4+ months for what should take 30-60 days.
We Make Mexico Registration Simple
Pure Global experts know your device category inside out
Deep Category Expertise
From classification to COFEPRIS submissionโwe handle the entire process. You just provide your device documentation.
Technical Documentation Excellence
Know exactly what you'll pay upfront. No surprises. No hourly billing. No hidden fees emerging mid-project.
Proven Registration Track Record
Our local Mexico office and streamlined process get your Class I device registered in 30-60 days, not 4+ months.
Ongoing Compliance Support
As an independent MRH, we're not your distributor. Change commercial partners anytime without losing your registration.
How It Works
Free Consultation
Tell us about your device. We'll confirm classification and provide an exact quote within 24 hours.
We Handle Everything
Send us your documents. We translate, prepare, and submit to COFEPRIS on your behalf.
Start Selling in Mexico
Receive your COFEPRIS registration number. Your device is legally marketable for 5 years.
Trusted by 300+ Medical Device Companies
โPure Global got our Class I device registered in just 45 days. Their transparent pricing saved us thousands compared to our previous consultant.โ
Carlos Martinez
VP Regulatory Affairs, MedDevice Solutions Inc.
Simple, Transparent Pricing
No hidden fees. Know exactly what you'll pay.
Starting from
$2,000/year
$3,000-$8,000 with traditional consultantsSave 60-80%
Ready to Enter the Mexico Market?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.