Register Your High-Risk Device in Mexico in 6-12 Months
Class III devices require clinical evidence and rigorous review. We guide you through COFEPRIS's most demanding pathway.
Free consultation โข No commitment required
6-12
Months to Market
300+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Class III Is COFEPRIS's Most Rigorous Pathway
Specialized devices need specialized expertise
Clinical Evidence Required
COFEPRIS demands clinical data proving safety and efficacy. Insufficient evidence means rejection or lengthy delays.
Extensive Technical Review
Every aspect of your device is scrutinizedโdesign, manufacturing, sterilization, biocompatibility, and more.
High Rejection Risk
Without expert preparation, Class III submissions face frequent deficiency letters and rejection cycles.
We Navigate Class III Complexity
Pure Global experts know your device category inside out
Deep Category Expertise
We help you compile and present clinical evidence that meets COFEPRIS's standardsโavoiding rejection cycles.
Technical Documentation Excellence
Our team prepares comprehensive documentation covering every COFEPRIS requirement for high-risk devices.
Proven Registration Track Record
When COFEPRIS requests additional information, we respond strategically to keep your registration on track.
Ongoing Compliance Support
Our Mexico office stays current on COFEPRIS's evolving requirements and reviewer expectations.
How It Works
Comprehensive Assessment
We evaluate your device, existing documentation, and clinical data. You'll receive a detailed gap analysis and timeline.
Dossier Development
Our regulatory experts compile your technical dossierโclinical summaries, risk analysis, and all supporting evidence.
Strategic Submission
We submit to COFEPRIS and manage the entire review process, including deficiency responses and reviewer communications.
Market Authorization
Receive your COFEPRIS registration certificate. Your Class III device is approved for sale in Mexico for 5 years.
Trusted for the Most Complex Registrations
โOur Class III implantable device seemed impossible to register in Mexico. Pure Global's team made it happen in 10 months. Their clinical strategy was invaluable.โ
Dr. Miguel Santos
VP Regulatory Affairs, Surgical Innovations Ltd.
Class III Investment
Expert support for high-risk devices
Starting from
$3,000/year
$12,000-$35,000 with traditional consultantsSave 60-80%
Ready to Register Your Class III Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.