BPO in RA

Expert ANVISA registration services Unlock the Brazilian medical device market with ease

Navigate Brazil’s complex regulatory landscape with Brisa Advisors.

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Brisa Advisors has been trusted by leading Companies

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Years Experience

Ease your entry: mastering Brazil's medical device market

“Brazil isn’t for amateurs”
– Famous quote from Tom Jobim
Author of the song The Girl from Ipanema.

Entering the Brazilian medical device market presents a unique set of challenges, from navigating Brazil’s medical device regulations to dealing with ANVISA’s stringent registration process.

At Brisa Advisors, we specialize in simplifying this journey for international medical device manufacturers aiming to expand your footprint in Brazil.

We Offer

Immeasurable benefits for your business

Direct Market Access

We facilitate your entry into the Brazilian market, removing regulatory barriers for a swift and efficient launch.

Cost Savings

We minimize your regulatory expenses, providing a cost-effective pathway to compliance and registration.

Tailored Solutions

We develop customized regulatory strategies, ensuring a perfect fit for your market needs.

Expert Guidance

Receive unparalleled advice from our team of experts, ensuring you navigate the regulatory landscape with confidence.

Time Efficiency

Our streamlined process accelerates your product’s journey to the market, saving valuable time and resources.

Compliance Assurance

We guarantee adherence to Brazil’s complex regulatory requirements, securing your product’s approval and market entry.

Our services

ANVISA Medical Device Regulations Expertise

Stay compliant with Brazil's regulatory requirements through our detailed understanding and application of ANVISA regulations.

Brazilian Registration Holder Services

Facilitate your market entry as a non-resident company with our registration holder services.

Custom Regulatory Strategies

Whether it's dealing with the Brazilian medical device classification rules, registration, or the regulatory framework, we devise tailor-made strategies to overcome any obstacle.

Cost-Effective Market Entry

Leverage our knowledge to achieve significant savings on ANVISA fees and streamline your product's journey to the market.

Transforming challenges into successes

Our proactive approach in the first merger case to change the legislation’s interpretation led to a pivotal shift in ANVISA’s regulatory framework.

This not only facilitated our client’s market entry but also resulted in substantial fee savings, exemplifying our commitment to turning regulatory challenges into victories for our clients.

Trust & Security

Integrity & Commitment

Brisa Advisors: pioneers in Brazilian medical device registrations

With nearly 30 years of experience in regulatory, governmental, and commercial sectors, Brisa Advisors has mastered the intricacies of the Brazilian market.

Specializing in medical device registration in Brazil, we offer unparalleled expertise to small, medium, and large international companies. Our successful collaborations with industry giants like Colgate Palmolive, Hoechst, Bayer, Sumitomo, and TELEFLEX group underscore our capability to navigate through the complexities of ANVISA medical device regulations, INMETRO, ANATEL certifications, and GMP certification requirements.

Testimonials

Learn what it's like to work with Brisa from our clients

"The partnership between Organ Recovery Systems and Brisa is now 11 years old, starting when it was still Brasil Import/Emergo. It has worked on the approval of all ORS products with ANVISA and has followed up on regulatory requirements, always anticipating possible adjustments to the good practices of the factories in the United States, meeting the regulatory demands required by the Health Surveillance Agency. The work, which often requires specialized human resources and represents an additional cost to the operation, was carried out with expertise and with controlled and predictable costs. But the most important part for me was the atmosphere of professionalism, mutual trust and absolute respect built up over these years of partnership. Not to mention that the current service outsourcing model - BPO in RA, a kind of monthly service subscription - represents a breakthrough in cost control and in the agility of the service provided."

"Comprehensive experience with and understanding of Brazil regulatory and reimbursement law and practice. Expertise in helping companies with strategy, planning, and navigating the complex process of securing new regulatory product registrations and product renewals Has long-standing professional relationships with the Brazil national regulatory and reimbursement administrations and community of specialist regulatory law attorneys and technical advisors Accessible, responsive, ethical, practical, innovative, hard working, Advice that can be trusted; no sugar coating or telling clients what they want to hear. Capability to provide realistic assessments of technical process requirements and timetable for development and prosecution of regulatory filings."

“I recognize your excellent and professional competence in national and international regulatory field based on your personal skills and from the long history of experience. A competent and professional service, not only business and/or commercial own oriented, which can support company as part of their internal team in the business strategy to penetrate as far as possible the international markets by obtaining the proper authorizations with the respect of legislations and Company ‘goals and timing. Expert, Results-driven, Professional."