Canada’s cosmetics regulations are undergoing major changes in 2025, and companies that sell into the Canadian market need to adapt quickly to remain compliant. From new labeling requirements to fragrance allergen disclosures and enhanced safety protocols, Health Canada’s updated rules will impact how products are formulated, packaged, and marketed.
In this webinar, our regulatory expert will walk you through the most important updates and what they mean for your business.
Agenda Highlights:
- Overview of Health Canada’s updated cosmetics regulations
- Labeling changes and new disclosure requirements
- Ingredient and fragrance allergen transparency
- Mandatory updates for contact information and responsible person
- Enhanced safety and product testing protocols
- Updated terms and definitions you need to know
- Key compliance deadlines for 2025 and beyond
- How Registrar Corp can support your compliance strategy
By the end of the session, you’ll have a clear roadmap for preparing your products, processes, and documentation to meet Health Canada’s 2025 requirements—ensuring smooth market access and reduced compliance 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.
