New Zealand In-Person Seminar: US FDA Compliance for Exports of Food & Beverage Products to the USA

317 English FB New Zealand Seminar 1 1
The United States regulates the import of all food and beverages, including products considered health supplements and traditional health remedies. The agency responsible for enforcing the various requirements is the US Food and Drug Administration (US FDA). While many of the regulatory and safety requirements are set forth in the Food, Drug, and Cosmetic Act (a law dating back to 1938), more recent requirements such as the Bioterrorism Act and the Food Safety Modernization Act (“FSMA”) have changed the complexity of exporting these products to the USA. With the evolving regulatory regime, more changes may be afoot.
This seminar will offer a comprehensive overview of existing and more recent FDA regulations and dive deep into strategies necessary for compliance and success. The speaker will also discuss critical changes unfolding within the food and beverage industry and shed light on the far-reaching impact of the “FSMA” regulations on food and beverage exports.
Throughout the seminar you will have the opportunity to hear from an industry expert from Registrar Corp who will guide you through the latest developments and help you to understand the implications for your exports to the United States.
This seminar will cover a wide range of essential topics, including:
The basic requirements of registering a foreign food facility, designation of a US Agent, and biennial renewals.
Prior Notice submissions and how US FDA utilizes your shipment data.
An overview of labeling, ingredient, and claims regulations and how to avoid the most common pitfalls.
The Food Safety Modernization Act which requires foreign manufacturers to develop, maintain, and operate under either HACCP or a Food Safety Plan. Learn how these documents are required by your US importer in order to comply with the new Foreign Supplier Verification Program.
FSMA 204
Identifying US Buyers
Export Opportunities to the USA under Trump 2.0

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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