Latin America's largest healthcare trade fair, with 1,250+ exhibitors, 90,000+ visitors from 70+ countries in 4 days at Expo Imigrantes in São Paulo. The HSC team at stand E-149, shared with Anbiotec, is ready to discuss your regulatory project.
Every market has its own authority, framework and timeline. Coordinating simultaneous registrations requires a methodology, rather than improvisation.
Recalls, sales suspensions and loss of market share. The cost of getting it wrong far exceeds the investment in doing it right.
EUDAMED on 28 May 2026, the QMSR/FDA transition and new ANVISA resolutions. Regulatory windows do not wait.
We work in two directions: bringing global manufacturers into Brazil and taking Brazilian companies to international markets. Choose your route.
For manufacturers from China, India, South Korea, Europe and the USA needing to register medical devices in Brazil. We manage the entire process as your local Registration Holder (BRH) and Importer of Record (IOR), from the modular technical dossier to ANVISA registration under RDC 751.
Start your market entryFor Brazilian manufacturers ready to expand internationally. We structure your ISO 13485:2016 quality system and dossiers for FDA QMSR, EU MDR/IVDR and the MDSAP audit covering five regulated markets in a single certification.
Start your expansionFrom notification to full registration under RDC 751. Modular technical dossiers, GMP and risk classification for all Classes I to IV.
Five markets in one MDSAP certification. The audit covers Brazil, the USA, Canada, Australia and Japan, with additional support for FDA QMSR and EU MDR 2017/745.
An end-to-end quality system. ISO 13485:2016 implementation aligned with RDC 665, with a pre-certification internal audit.
Your local Registration Holder (BRH) and Importer of Record (IOR) for entering the Brazilian market without establishing your own CNPJ.
Exemplar Global MDSAP RTP, with instructors also accredited by RAPS. Live training recognised in 30+ countries.
The HSC team will be present throughout all 4 days. Decision-making, bilingual support and technical depth in a single conversation.
CEO and founder
Exemplar Global MDSAP RTP. Former BSI Lead Auditor.
Business Development
Leads HSC's international expansion. A strategic link between global manufacturers and ANVISA registration.
MDSAP Lead Auditor
Technical depth for regulatory questions on the spot.
30-minute slots, with direct access to our regulatory specialists.
CEO and founder, HSC Global Group
A graduate in Commercial Management from UNINOVE, with postgraduate studies in People Management and Digital Marketing. More than 15 years of experience in commercial management and team leadership, structuring and growing businesses in healthcare technology.
At HSC Global Group, a technology company specialising in regulatory consultancy and quality management for medical devices, he leads operations, commercial strategy and domestic and international market development, connecting manufacturers with the regulatory requirements of Brazil and major global markets.
Business Development
Rafael is responsible for HSC Global Group's international expansion, identifying and developing opportunities with medical device manufacturers in Europe, Asia and Latin America seeking entry into the Brazilian market.
With a Business Administration background and fluency in English, he builds strategic connections between international companies and the ANVISA registration process, positioning HSC Global as a leading regulatory partner in Brazil.
MDSAP Lead Auditor
Exemplar Global certified MDSAP Lead Auditor, with more than 8 years of experience in ISO 13485 QMS implementation and work across the MDSAP programme's 5 countries.
