OUR SERVICES
Navigating the Brazilian healthcare market requires more than just great technology; it demands local regulatory mastery. We provide end-to-end advisory—from ANVISA registration and INMETRO certification to strategic distribution setups. Our mission is to streamline your market entry, mitigating risks and ensuring your innovations reach the Brazilian market with efficiency and full compliance.
Explore our comprehensive suite of services now:
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)
- Support during ANVISA technical questions
Post-Market Support
- Change management (product updates, renewals, transfers)
- Vigilance and adverse event reporting
- Regulatory monitoring and updates
Logistical 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 packingrequirements 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 Invoice for customers according with Brazilian legislation
Establishing Offices in Brasil
- 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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