Canada Cosmetic Labelling Requirements: What Brands Need to Know

July 28, 2026 by Nancy Misra

Entering Canada’s cosmetics market requires labels that meet Health Canada’s requirements for bilingual content, mandatory information, product claims, and Cosmetic Notification Form alignment.

Madelyn Martinez, our cosmetics labelling expert, will explain the key requirements companies must address when preparing cosmetic products for the Canadian market.

The session will cover:

An overview of Health Canada’s cosmetic regulatory framework

Mandatory information required on cosmetic labels

Inner and outer label requirements

English and French bilingual labelling requirements

Consistency between the product label and the Cosmetic Notification Form

How to distinguish cosmetic claims from therapeutic claims

Common Canadian cosmetic labelling compliance risks

Practical steps to improve compliance before market entry

Whether you manufacture, import, or market cosmetics in Canada, this webinar will help you understand Health Canada’s labelling requirements and prepare your products for compliant market entry.

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.

For Medical Device Establishments, who must register?

What information is submitted for medical device establishment registration?

Who must provide medical device listings?

What information is submitted for a medical device listing?

What is a master file?

Subscribe To Our News Feed