Register Your ENT Device in Mexico
Hearing aids, cochlear implants, endoscopes, surgical instrumentsโspecialist COFEPRIS registration for ENT products.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
ENT Devices Range from Simple to Highly Complex
Specialized devices need specialized expertise
Implant Complexity
Cochlear implants and bone-anchored hearing devices face Class III requirements with extensive clinical data needs.
Active Device Requirements
Electronic hearing devices need electrical safety testing, EMC compliance, and software validation.
Endoscope Specifics
ENT endoscopes require reprocessing validation, optical performance data, and sterilization compatibility proof.
We Specialize in ENT Devices
Pure Global experts know your device category inside out
Deep Category Expertise
Cochlear implant and hearing device registration
Technical Documentation Excellence
ENT surgical instrument portfolio registration
Proven Registration Track Record
Endoscope and visualization system expertise
Ongoing Compliance Support
Active device electrical safety documentation
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 ENT Device Companies
โOur hearing aid line is now available in Mexico. Pure Global handled the active device requirements efficiently.โ
Hans Weber
Global Regulatory Manager, AudioMed 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 ENT Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.