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Brazil Life Sciences: ANVISA Approvals & Licensing Essentials


Sector: Life Sciences

Market Region: Latin America

Date: June 11, 2025 (07:00-08:00, EST)

The Ministry of Economic Development, Job Creation and Trade, in collaboration with the Montt Group and AKLA Consulting, is pleased to invite Ontario-based healthcare companies to a complimentary webinar: "Brazil Life Sciences: ANVISA Approvals & Licensing Essentials."

 

This webinar will provide Ontario companies in the Life Sciences sector with a comprehensive overview of Brazil’s regulatory framework for health products and medical devices. The session will be particularly valuable for businesses planning to enter or expand their presence in the Brazilian market, offering clarity on how to successfully navigate the country’s regulatory environment.

 

Topics will include:

 

  • Health Product Notification and Registration:
    An introduction to the processes involved in notifying and registering health products, including pharmaceuticals, cosmetics, and food supplements, with Brazil’s National Health Surveillance Agency (ANVISA). Although these categories share some similarities, each is governed by distinct regulations.

     

  • Medical Device Licensing:
    A focused look at the regulatory path for medical devices, covering classification systems, the step-by-step registration process, and the necessary documentation required for both domestic and international manufacturers to secure ANVISA approval.

     

  • Key ANVISA Authorizations:
    An overview of the core authorizations needed to commercialize health products and medical devices in Brazil. This session will help companies better understand the essential compliance steps for efficient market access.

     

Q&A Session:
The webinar will conclude with an interactive Q&A, giving participants the opportunity to ask questions specific to their business needs and regulatory concerns.

 

Featured Speakers:

Amanda Kotzias, Technical Director at AKLA Consulting / Montt Group

Amanda brings extensive experience and in-depth regulatory expertise in the Brazilian life sciences sector, having supported numerous international companies through successful ANVISA submissions and market entry strategies.

 

Melania Lopez-Videla, Commercial Director at Montt Group.

Melania has supported numerous businesses in navigating regulatory compliance, market trends, and cultural aspects, ensuring their successful growth in Brazil and other Latin American markets. 

 

Contact:
Cinthya Ortiz
Area Director, South America | Trade Programs Branch, MEDJCT
Email: cinthya.ortiz@ontario.ca
Phone: 437-777-3186

 

Note: If you are a member of the municipal, provincial, or federal government, please do not register via this website. Instead, contact the event organizer to participate. 

 

After submitting your registration, you will receive an automated confirmation email. Event details will be shared after the registration deadline.

Organisation

Ministry of Economic Development, Job Creation and Trade

Contact

Ortiz, Cinthya
Email: Cinthya.Ortiz@ontario.ca
Tel: +1 (437) 777-3186

Updated: June 3, 2025
Published: May 9, 2025