Expanding into North America brings enormous opportunity—but navigating three distinct food-labeling systems can be challenging. This webinar provides a clear, practical roadmap to help manufacturers, brand owners, and exporters understand and meet labeling requirements in the United States, Mexico, and Canada. Join our regulatory experts as they break down the key similarities and differences across these markets, including mandatory label elements, nutrition labeling formats, ingredient declarations, allergen requirements, language rules, and recent regulatory updates. You’ll also learn common pitfalls to avoid and strategies to streamline compliance when selling in multiple countries. Whether you’re launching a new product, reformulating an existing line, or preparing for cross-border expansion, this session will equip you with the knowledge and confidence to ensure your labels are accurate, compliant, and market-ready.
Key Takeaways:
- Understand core food-labeling regulations in the US, Mexico, and Canada
- Learn how nutrition facts, claims, and ingredient lists differ across markets
- Identify bilingual and formatting requirements unique to each country
- Prepare for regulatory changes affecting packaging and claims
Perfect for regulatory affairs professionals, quality teams, product developers, exporters, and brand owners entering or expanding in the North American marketplace.
For Medical Device Establishments, who must register?
Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee.
What information is submitted for medical device establishment registration?
In addition to registering with FDA, most owners or operators of medical device establishments must also submit a list of all devices during their annual registration renewal.
- U.S. Facilities
- Initial importers must identify the manufacturers of the devices they are importing.
- A device must be listed if they fall under the any of the following:
- Contract Manufacturer
- Contract Sterilizer
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U. S. manufacturer of export only devices
- Non-U.S. Facilities
- Must list devices, provide a U.S. Agent, and identify importers.
Who must provide medical device listings?
In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.
All facilities that fall under any of the following functions:
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U.S. manufacturer of export only devices
What information is submitted for a medical device listing?
Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.
- Company function (activity)
- Device product code
- Proprietary names
- Importer information
What is a master file?
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.
