Register Your Orthopedic Device in Brazil
Joint replacements, trauma fixation, spine implants, sports medicineโspecialist ANVISA registration for orthopedics.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
10yr
Registration Validity
Orthopedic Implants Face Maximum Scrutiny
Specialized devices need specialized expertise
Long-Term Implant Data
Joint replacements and spine implants require long-term survival data and clinical evidence.
Material Complexity
Metal alloys, ceramics, PEEKโeach material requires specific biocompatibility documentation.
System Registration
Orthopedic systems with multiple components require coordinated registration of all elements.
We Specialize in Orthopedic Devices
Pure Global experts know your device category inside out
Deep Category Expertise
Joint replacement system registration (hip, knee, shoulder)
Technical Documentation Excellence
Spine implant and instrumentation expertise
Proven Registration Track Record
Trauma fixation device portfolio registration
Ongoing Compliance Support
Sports medicine and arthroscopy 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 Orthopedic Device Companies
โOur knee replacement system is now available in Brazil. Pure Global's orthopedic expertise was invaluable.โ
Dr. William Brooks
Chief Regulatory Officer, OrthoTech 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 Orthopedic Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.