Register Your OB/GYN Device in Mexico
Fetal monitors, IUDs, surgical instruments, imagingโcomprehensive COFEPRIS registration for women's health products.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
5yr
Registration Validity
OB/GYN Devices Span Diverse Regulatory Pathways
Specialized devices need specialized expertise
Fetal Device Sensitivity
Devices used during pregnancy face heightened scrutiny on maternal and fetal safety.
Contraceptive Complexity
IUDs and contraceptive devices combine medical device with drug-like requirements.
Monitoring Accuracy
Fetal monitoring devices require extensive accuracy validationโlives depend on correct readings.
We Specialize in OB/GYN Devices
Pure Global experts know your device category inside out
Deep Category Expertise
Fetal monitoring system registration
Technical Documentation Excellence
IUD and contraceptive device expertise
Proven Registration Track Record
OB/GYN surgical instrument portfolio registration
Ongoing Compliance Support
Women's health imaging 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 OB/GYN Device Companies
โOur fetal monitoring system is now in Mexican hospitals thanks to Pure Global's OB/GYN device expertise.โ
Dr. Jennifer Walsh
Regulatory Director, FetalCare 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 OB/GYN Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.