New Zealand In-Person Seminar: US FDA Compliance for Cosmetics Products to the USA

February 27, 2025 by Alexis Ocampo

317 English Cosmetics New Zealand Seminar 1 1
The United States regulates the import of all cosmetics, including over-the-counter (OTC) drug products. The agency responsible for enforcing the various requirements is the US Food and Drug Administration (US FDA). The United States recently enacted the Modernization of Cosmetic Regulations Act of 2022 (MoCRA), which significantly expands the regulatory authority of the U.S. Food and Drug Administration (FDA) over the cosmetics industry. MoCRA came into effect on 1st July 2024.
This seminar will offer a comprehensive overview of MoCRA and deep dive into strategies necessary for compliance and success. The speaker will also discuss critical changes unfolding within the cosmetic industry and shed light on the far-reaching impact of the new MoCRA regulations for Cosmetics 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 of MoCRA for exports to the United States.
This seminar will cover a wide range of essential topics, including:
A detailed exploration of MoCRA’s requirements for cosmetics, allowing you to navigate the specific obligations imposed by the new regulations.
In-depth discussions on cosmetics labeling, adverse events, and Good Manufacturing Practices (GMPs) regulations, enabling you to implement compliant practices and ensure product quality.
Best practices for compliance, providing practical guidance to ensure adherence to the latest FDA guidelines and maximize your business’s regulatory compliance efforts
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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