Exporting Medical Devices: What US Manufacturers Need Before Entering New Markets

US medical device and IVD manufacturers looking to expand internationally often find that the documentation supporting their domestic business does not travel well.

What US Manufacturers Need to Know Before Expanding Internationally

In this episode of Reg with MEG, Jasmine Hall, Senior Regulatory Affairs Consultant at MedEnvoy, joins Tiffany Brown to discuss what US medical device and IVD manufacturers should have in place before entering international markets. The conversation covers documentation readiness, how to choose a first market, the issues that most often delay approvals, the role of in-country partners, and the obligations that continue after approval.

Check out the full episode below:

Key Takeaways from This Episode

• A clearance is not market access. Asked how often US manufacturers assume their clearance is enough to expand, Jasmine’s answer was that it happens all the time, and that it is one of the more common reasons companies come looking for a consultant.
• US documentation is built for a different bar. Files assembled around a predicate device, or prepared for a potential onsite audit but never submitted for external review, tend to show their gaps as soon as they reach a more demanding market.
• Labeling is the number one source of delay. Translation, packaging layout constraints, and technical specifications that depend on current testing data all stack on top of one another, and each step waits on the one before it.
• Clinical evidence is the gap most manufacturers do not see coming. For lower-class devices, that information is generally not required in the US, so it is rarely on file when a market such as the EU asks for it.
• Market selection starts with need and funding. Where the product will actually sell, whether reimbursement applies, and how entry will be paid for come before the regulatory strategy, not after it.
• In-country partners are not administrative. Authorized representatives, importers, and distributors are who you call when product is flagged at a border, and in some cases they are the ones required to make post-market filings.
• Customs is the underestimated one. Once product arrives in a market it is inspected, and registration, labeling, packaging, and contents all have to hold up.

Listen to the Full Episode

Jasmine walks through each of these in detail, along with practical first steps for companies planning to export this year. Listen to the full conversation on Spotify or YouTube.

If you have questions about entering a new market, contact MedEnvoy’s team of regulatory experts by clicking here, or learn more about our consulting services by clicking here.

SHOW NOTES

US medical device and IVD manufacturers often assume the documentation behind their domestic business will support international expansion. Jasmine Hall, Senior Regulatory Affairs Consultant at MedEnvoy Global, joins Tiffany Brown to explain what export readiness actually requires, where US files typically fall short, and how to sequence a market entry strategy.

In this episode:

• 00:44 Welcome and introduction
• 01:03 What it means to be export ready
• 02:08 The biggest mistakes US manufacturers make
• 03:11 “We have a clearance, we’re good” — does that hold up?
• 04:41 Choosing your first international market
• 06:04 Documentation and submission issues that delay approvals
• 07:52 The role of representatives, distributors, and in-country partners
• 09:20 Post-approval obligations manufacturers underestimate
• 10:20 First practical steps for companies exporting this year

MedEnvoy Global is an ISO 13485 certified regulatory compliance partner supporting medical device, IVD, and cosmetics manufacturers entering international markets. We provide in-country representation, regulatory importer services, and RA/QA consulting across the EU, UK, Switzerland, US, and markets throughout LATAM, the Middle East, and Asia-Pacific.

Talk to our team: https://medenvoyglobal.com/talk-to-an-expert/