Key U.S. FDA Requirements for Exporting Seafood Products to the USA

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Join Registrar Corp for an in-depth webinar designed for seafood exporters across Southeast Asia and the Pacific looking to enter or expand in the U.S. market. 

 The United States represents a major growth opportunity for seafood exporters. It is one of the world’s largest seafood importers, with over $25 billion in annual imports and over 60% of its seafood supply sourced from abroad. However, exporting seafood to the U.S. involves complex and highly specialized regulatory requirements that differ significantly from other food products. 

 In this webinar, our experts will break down key U.S. FDA requirements for seafood, including HACCP plan expectations, FCE-SID requirements for canned products, and other critical compliance considerations. We will also cover the new 2026 Certificate of Admissibility (COA) requirement under the U.S. Marine Mammal Protection Act (MMPA), which will impact exporters from several countries in the region. 

Whether you are new to the U.S. market or looking to strengthen your compliance strategy, this session will provide practical insights to help you navigate regulations with confidence. A live Q&A session will follow. 

 

About the Speaker(s): 

Vijey Ananda: With extensive experience in regulatory compliance, international banking, education, and management consulting, Vijey Ananda leads a team in ASEAN/Oceania which assists local exporters with global compliance for food & beverages (including US FDA), cosmetics, medical devices, and drug products. Vijey holds an MBA from London Business School. 

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:

  1. Contract Manufacturer
  2. Contract Sterilizer
  3. Foreign Exporter
  4. Manufacturer
  5. Relabeler / Repackager
  6. Remanufacturer
  7. Reprocessor of Single Use Device
  8. Specification Developer
  9. 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.

  1. Company function (activity)
  2. Device product code
  3. Proprietary names
  4. 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.

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