The Ministry of Economic Affairs is pleased to announce a webinar presented by Registrar Corp: An Update on US FDA Regulations, Best Practices, and Common Challenges – and Recommended Solutions for the Foreign Exporter.
As the U.S. Food and Drug Administration (FDA) continues to update and refine regulations for food and cosmetic products, it’s more important than ever for Bahamian businesses to stay informed and compliant. This session will provide an overview of the latest regulatory shifts in 2025, highlight common pitfalls foreign exporters face when entering the U.S. market, and share best practices to help your business achieve and maintain compliance.
Whether you are currently exporting to the U.S. or planning to expand, this webinar will give you the knowledge and strategies needed to confidently navigate FDA requirements and position your business for success.
👉 Watch to learn:
- Key FDA updates impacting food and cosmetic products in 2025
- Best practices for foreign exporters entering the U.S. market
- Common compliance challenges – and practical solutions
- How to prepare your business to be US FDA market ready
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.
