Speak to a an expert

200

+

Medical Device Experts
1000

+

Projects
400

+

Customers
40

+

Countries
1350

+

No. of Approvals

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

Book a meeting with our experts today

Why Choose Freyr for Brazil Medical Device Registration?

  • 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

    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

    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

    Our experienced Brazilian Registration Holders (BRH) ensure seamless compliance with ANVISA medical device registration.

  • 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.