OUR SERVICES
Navigating the Brazilian healthcare market requires more than regulatory approval. It requires a clear understanding of market potential, competition, pricing, distribution channels and local compliance. FSC provides integrated support throughout the market-entry journey—from market intelligence and go-to-market planning to ANVISA registration, local representation, logistics and operational setup.
Explore our comprehensive suite of services now:
Market Intelligence & Entry Strategy
- Brazilian market size and import analysis;
- Competitive landscape and player profiles;
- Distributor and strategic partner mapping;
- Public procurement and pricing intelligence;
- Go-to-market and regulatory entry strategies;
- Market monitoring and competitive alerts.
ANVISA Registration & Notification
- Medical/ Dental Devices, Material and Software (Classes I, II, III, and IV);
- INMETRO certification (mandatory for some products);
- ANATEL certification (mandatory for wireless functions);
- Risk classification and regulatory strategy;
- Preparation and submission of technical dossiers.
Brazilian Registration Holder
- Acting as the legal Brazilian Registration Holder;
- Regulatory representation before ANVISA;
- Ongoing compliance and product lifecycle management.
Regulatory Consulting
- Gap analysis and regulatory feasibility assessment;
- Labeling and IFU review (Portuguese compliance);
- Suppor during ANVISA tchnical questions.
Post-Market Support
- Change management (product updates, renewals, transfers);
- Vigilance and adverse event reporting;
- Regulatory monitoring and updates.
Logistics Support in Brasil
- Support to domestic delivery transportation from a central storage;
- Support in transportation contracting to meet ANVISA regulations;
- Support for domestic transportation insurance;
- Consultancy for packing requirements for domestic deliveries
Distribution Center
- Renting storage area with approved specifications (ANVISA etc);
- Supply of stock control;
- Supply of receiving checks and pre-delivery tests;
- (Re) Packing pre-delivery to customer;
- Issuing invoices in accordance with Brazilian legislation.
Establishing Offices in Brazil
- Support to find office space for renting with the area as customer request/needs;
- Support for selection of office people, from manager to auxiliary clericals;
- Support to have due regularization of the customer branch as per requirements (purpose and legally mandatory permits as well as sanitary approvals);
- Support for obtaining of the customer taxpayer and similar registrations.
+55 (11) 99165-1710
(Mobile and WhatsApp)
+55 (11) 99214-6574
(WeChat)
info@fscregulatory.com.br
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