US Export Opportunities & Tariff Insights Webinar
This webinar brings together key trade and regulatory experts to unpack recent changes impacting Australian medical technology companies seeking to enter or grow in the US market. With new tariffs and regulatory updates reshaping the landscape, this session will provide timely insights and practical pathways for navigating these shifts.
Background
The USA has traditionally been the first ‘go-to market’ for Australian early-stage, growth, and expansion-stage medical device companies. Aside from the sheer size and value of the US healthcare market, the 2005 US-Australia Free Trade Agreement (USFTA) facilitated trade in medical devices by reducing or eliminating tariffs, improving transparency in government procurement, and promoting regulatory cooperation between the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA). The FDA regulatory framework was relatively well understood in terms of various approval pathways.
Objective
- To provide up to date insights into the challenges for AU medical device export companies created by the new tariffs regime and changes to the FDA.
- To enable AU medical device export companies to explore alternative market entry and access pathways.
- Practical strategies for market access, entry, and manufacturing validation in the US.
Learn Outcomes
- How recent US tariff changes could impact your business
- Practical strategies to manage export regulations
- Key insights to unlock growth opportunities in the US market
This event is highly relevant for both emerging startups and established MedTech companies.
Featured Speakers
- Tara Booth, Assistant Secretary, US Trade Taskforce – Department of Foreign Affairs and Trade (DFAT)
- Rachel Howard, Trade Commissioner, New York – Austrade
- Marco Theobald - Registrar Corp
- Stuart Elliott, Executive Director – Planet Innovation
Free webinar for members and non-members.
Additional Information
Speaker Profiles
Tara Booth, Assistant Secretary, US Trade Taskforce – Department of Foreign Affairs and Trade (DFAT)
Tara Booth is Deputy Lead of the US Trade Taskforce in the Australian Department of Foreign Affairs and Trade.
Tara is an international trade lawyer, negotiator and diplomat. She is an experienced litigator with expertise in World Trade Organization (WTO) dispute settlement.
Tara has completed a posting to Australia’s Permanent Mission to the WTO in Geneva as Legal Counsellor and represented Australia in trade negotiations, including the ASEAN-Australia-New Zealand Free Trade Agreement and the China-Australia Free Trade Agreement.
Tara holds a Masters of Law from the University of Queensland and a Bachelors in Arts and Law (Hons.) from Queensland University of Technology.
Rachel Howard, Trade Commissioner, New York – Austrade
Rachel oversees Austrade’s operations in the US northeast region, supporting Australian exporters and investors. She has deep expertise in trade facilitation, international business strategy, and building cross-market partnerships.
Cindy Valenzona - Registrar Corp
Cindy Valenzona is the Manager of Medical Device Services at Registrar Corp, where she leads a team dedicated to assisting medical device companies comply with the U.S. Food and Drug Administration (FDA) and Health Canada regulatory requirements.
She began her career at Registrar Corp in 2018 as a Regulatory Specialist, supporting thousands of companies worldwide with Food Facility Registrations. A year later, she transitioned to the Medical Device Department, where she specialized in FDA Medical Device Registration and Listing, Health Canada Establishment Licensing, UDI submissions, and Electronic Medical Device Reporting (eMDR).
Her continued leadership and regulatory expertise led to her promotion to Manager in 2024, where she now drives key initiatives and ensures to deliver expert regulatory guidance to clients across the medical device industry.
Stuart Elliott, Executive Director – Planet Innovation
Stuart is a co-founder of Planet Innovation, a leading healthtech innovation and commercialisation company. He works with global MedTech companies to bring medical devices from concept to market, with strong experience in US regulatory and manufacturing environments.
