Register Your Surgical Device in Mexico
Instruments, implants, sutures, meshesโspecialist COFEPRIS registration for general and plastic surgery products.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
Surgical Devices Face Rigorous Safety Review
Specialized devices need specialized expertise
Implant Complexity
Breast implants, mesh products, and tissue expanders face Class III requirements with extensive clinical data needs.
Biocompatibility Standards
Long-term implantable devices require comprehensive biocompatibility testing per ISO 10993.
Post-Market Vigilance
Aesthetic implants face enhanced post-market surveillance requirements in Mexico.
We Specialize in Surgical Devices
Pure Global experts know your device category inside out
Deep Category Expertise
Surgical implant registration (breast, mesh, tissue)
Technical Documentation Excellence
Surgical instrument portfolio registration
Proven Registration Track Record
Suture and wound closure device expertise
Ongoing Compliance Support
Biocompatibility documentation for long-term implants
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 Surgical Device Companies
โOur breast implant line is now registered in Mexico thanks to Pure Global's expertise with aesthetic device regulations.โ
Dr. Rachel Kim
Chief Regulatory Officer, AesthetiMed 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 Surgical Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.