Register Your Maximum-Risk Device in Brazil in 9-12 Months
Class IV devicesโlife-sustaining implants, drug-delivery systemsโface ANVISA's highest scrutiny. We've done this before.
Free consultation โข No commitment required
9-12
Months to Market
500+
Devices Registered
60-80%
Cost Savings
10yr
Registration Validity
Class IV Is ANVISA's Highest Bar
Specialized devices need specialized expertise
Life-Critical Devices
Pacemakers, drug-eluting stents, implantable pumpsโdevices that sustain life face the most rigorous review possible.
Extensive Clinical Data
ANVISA requires robust clinical trials, long-term safety data, and comprehensive risk-benefit analysis.
Regulatory Complexity
Class IV combines medical device regulations with pharmaceutical-level scrutiny. One misstep can cost you a year.
We Specialize in Maximum-Risk Devices
Pure Global experts know your device category inside out
Deep Category Expertise
We help structure and present your clinical evidence to meet ANVISA's highest standards for Class IV devices.
Technical Documentation Excellence
Our regulatory team builds comprehensive submissions covering every aspect ANVISA will examine.
Proven Registration Track Record
Class IV projects get senior regulatory oversight with direct communication to our Brazil office.
Ongoing Compliance Support
We help you prepare for ANVISA's post-market surveillance requirements before you even submit.
How It Works
Executive Assessment
Senior regulatory experts evaluate your device, clinical data, and global registrations. You'll receive a detailed roadmap.
Strategic Dossier Development
We compile your Class IV submissionโclinical summaries, risk management files, biocompatibility data, and more.
ANVISA Engagement
We manage submission, reviewer meetings, deficiency responses, and all regulatory communications.
Market Authorization
Receive your ANVISA Class IV registration. Your life-critical device is approved for Brazil's 200+ million population.
Trusted for the Most Complex Registrations
โPure Global registered our Class IV cardiac device when two other consultants told us it was impossible. Their clinical expertise and ANVISA relationships made the difference.โ
Dr. Robert Kim
VP Regulatory Affairs, Advanced Cardiac Solutions
Class IV Premium Service
Expert support for maximum-risk devices
Starting from
$3,000/year
$25,000-$60,000 with traditional consultantsSave 60-80%
Ready to Register Your Class IV Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.