We are confirmed to participate in MEDICA 2025 with a clear objective: to connect international medical device manufacturers to the Brazilian market through our specialized medical device consulting and Brazilian hosting service.
In the meeting, we will discuss:
- Feasibility of registering your product with Anvisa
- Timeline and necessary investment
- Requirements of RDC 751/2022 and other applicable regulations
- Strategy for entering the Brazilian market
- Potential commercial partners and distributors
Exclusive bonus for those who schedule at MEDICA:
- Free preliminary analysis of technical documentation
Why Choose Us? Differentiators That Make a Difference
1. Proven Regulatory Expertise
- Exclusive Specialization in Medical Devices
We are not a generalist consultancy, which means:
- In-depth knowledge of all applicable RDCs
- Complete mastery of RDC 751/2022 (Good Manufacturing Practices)
- Practical experience with all risk classes (I, II, III, and IV)
- Constant updates on Anvisa regulatory changes
- Highly Qualified Team
Our team is composed of:
- Healthcare professionals specialized in regulatory affairs
- Bilingual experts (Portuguese/English) for international service
2. Complete and Transparent Process
- Structured 7-Step Methodology
Our process was developed to ensure efficiency, predictability, and full compliance:
3. Deep Knowledge of RDC 751/2022
- Specialization in Good Manufacturing Practices
RDC 751/2022 establishes the Good Manufacturing Practices (GMP) requirements for health products in Brazil. Many international companies face difficulties in adapting their processes to this regulation.
- Our Expertise:
- Certification and Maintenance
- Support in certification audits
- Management of non-compliances
- Corrective and preventive actions
- Continuous maintenance of the system
4. Complementary Services for Market Entry
In addition to Anvisa registration, we offer complete support for establishment in Brazil:
- Commercial Consulting
- Identification of Distributors:
- Established network with major Brazilian distributors
- Profile analysis and suitability by segment
- Intermediation of introductions
- Support in contractual negotiations
- Market Analysis:
- Commercial feasibility study
- Pricing strategy
- Sales projections
Wherever you are in the world, we are ready to bring your products to the Brazilian market with safety, agility, and total compliance. See you at MEDICA 2025!
- LinkedIn: Follow our page and send a message
- Calendly: Schedule your Meeting
Find out more about BPO in RA!
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
