Register Your Ophthalmic Device in Mexico
IOLs, lasers, diagnostic systems, surgical instrumentsโspecialist COFEPRIS registration for eye care products.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Ophthalmic Devices Require Specialized Expertise
Specialized devices need specialized expertise
Implant Complexity
IOLs and implants face Class III requirements with extensive biocompatibility and optical performance data needs.
Laser Safety Standards
Ophthalmic lasers require comprehensive safety testing, calibration data, and user training documentation.
Diagnostic Precision
OCT, topography, and biometry devices need extensive accuracy and repeatability validation.
We Specialize in Ophthalmic Devices
Pure Global experts know your device category inside out
Deep Category Expertise
IOL and ophthalmic implant registration
Technical Documentation Excellence
Ophthalmic laser and surgical system expertise
Proven Registration Track Record
Diagnostic imaging device registration (OCT, topography)
Ongoing Compliance Support
Contact lens and vision correction device registration
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 Ophthalmic Device Companies
โPure Global registered our complete IOL portfolio in Mexico. Their ophthalmic expertise accelerated our market entry.โ
Dr. Robert Liu
SVP Regulatory Affairs, ClearVision Implants
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 Ophthalmic Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.