As global trade dynamics continue to shift, customs brokers, international suppliers to the U.S., and importers must stay ahead of critical regulatory and policy changes that directly impact compliance and operations. From the evolving enforcement priorities at the U.S. Food and Drug Administration (FDA) to renewed scrutiny of de minimis thresholds and tariff policy under the Trump administration, the 2025 landscape presents both challenges and strategic considerations.
Join experts from NCBFAA and Registrar Corp for a timely discussion on what’s changing—and what it means for you. This 60-minute webinar will cover:
- Key updates in FDA oversight and enforcement priorities
- The impact of shifting tariff strategies and exclusion policy
- Developments in de minimis regulation and their effect on e-commerce and small-parcel imports
- Practical implications for customs brokers, importers, and logistics professionals
Whether you’re navigating increased regulatory scrutiny or advising clients through uncertain trade conditions, this session will provide actionable insights to help you adapt with confidence.
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.
