Register Your Cardiovascular Device in Mexico
From stents to pacemakers, cardiovascular devices face COFEPRIS's most rigorous scrutiny. We've registered hundreds.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Cardiovascular Devices = Maximum Regulatory Scrutiny
Specialized devices need specialized expertise
Class III Classification
Nearly all cardiovascular devices are high risk. COFEPRIS demands extensive clinical evidence.
Clinical Trial Requirements
Implants require robust long-term safety data. Missing or weak clinical evidence means rejection.
Highest Rejection Rate
Cardiovascular submissions face the highest deficiency rates at COFEPRIS. Expert preparation is essential.
We Specialize in Cardiovascular Devices
Pure Global experts know your device category inside out
Deep Category Expertise
Clinical evidence strategy for implantable cardiovascular devices
Technical Documentation Excellence
Biocompatibility and long-term safety data compilation
Proven Registration Track Record
Stent, valve, and pacemaker registration expertise
Ongoing Compliance Support
Post-market surveillance planning for life-sustaining devices
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 Cardiovascular Device Companies
โOur drug-eluting stent seemed impossible to register in Mexico. Pure Global's clinical strategy made it happen in 10 months.โ
Dr. James Morrison
Chief Regulatory Officer, CardioStent Technologies
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 Cardiovascular Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.