Fragrance and flavor ingredients are central to cosmetics and personal care products, but they’re also highly regulated due to their complexity and potential allergens. With the 51st Amendment to the International Fragrance Association (IFRA) Standards going into effect on October 30, 2025, the time to act is now.
This significant update introduces new ingredient restrictions, clarifications, and compliance changes. If your formulations aren’t aligned by the deadline, you could face costly regulatory action.
In this webinar, you will learn:
- What the IFRA Standards mean for your products and your company
- Critical deadlines in the 51st Amendment implementation timeline
- Key changes: updated restrictions, clarified guidelines, and new requirements
- What you must do now to prepare and how waiting could put your company at risk
- How expert support from Registrar can help you navigate the changes and assure compliance
Register today and take the first step toward protecting your brand and staying ahead of regulatory risk.
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.
