,Freyr’s Competencies in Brazil Medical Device Registration
Freyr simplifies your medical device product registration process with expert services tailored to your needs:
- Regulatory Intelligence Report for Brazilian market
- Due-diligence Report
- Regulatory Strategy
- Device classification and grouping
- Certification Services -
- MDSAP Certification
- BGMP Certification
- INMETRO Certification
- Brazil Registration Holder Services-
- Renewal of Brazil Registration Holder (BRH) Services
- Transfer of Brazil Registration Holder (BRH) Services
- Post approval device life cycle management
- Import clearance
- Safety reports / PMS reports
- Labeling Services
- Labeling review
- Translation of label documents
Experience seamless approval process for Medical Devices in Brazil
Celebrating Customers Success
Medical Devices
Registration and LR Support
Global
Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.
Arie Henkin
VP - Quality and Regulatory, Australia -based, Leading SaMD Company
Medical Devices
Swiss Rep Services
Japan and Switzerland
I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.
Darren Mansell
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company
Medical Devices
Registration and AR Services
Malaysia and Indonesia
Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.
Robert Menadue
Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company
Why Choose Freyr for Brazil Medical Device Registration?
![On-Time Submissions]( "On-Time Submissions")
100% On-Time Submissions
Don’t let delays cost you market opportunities. Freyr guarantees timely submissions, giving you the confidence to plan your medical device registration strategy without uncertainty.
![Proven Track Record]( "Proven Track Record")
Proven Track Record
With over 50 successful projects in Brazil and a growing list of satisfied clients, we know the Brazil medical device registration market inside and out.
![End-to-End Solutions]( "End-to-End Solutions")
End-to-End Solutions
From medical device product registration to post-market services, Freyr handles every step of the process, so you don’t have to. No need for multiple vendors—Freyr does it all.
![Trusted Local Expertise]( "Trusted Local Expertise")
Trusted Local Expertise
Our experienced Brazilian Registration Holders (BRH) ensure seamless compliance with ANVISA medical device registration.
![Accelerated Market Access]( "Accelerated Market Access")
Accelerated Market Access
While others are still figuring out how to navigate the complexities of medical device registration, you will be reaching the market faster and more efficiently with Freyr by your side.
