Hello @Seller_9Wf4WMYo3pGdc,

Thank you for your question about selling an oral irrigation device or water flosser in Canada. This is an important topic as it involves regulatory compliance, which is crucial for selling health-related products.

Here's some general guidance:

1. Medical Device Classification: In Canada, oral irrigation devices are typically classified as Class I medical devices. However, classification can vary based on the specific features and intended use of the product. Please review the help page: Medical devices and accessories.
2. Medical Device License: For most Class I medical devices in Canada, you don't need to obtain a Medical Device License. However, you do need to ensure compliance with Health Canada regulations.
3. Establishment License: While you may not need a Medical Device License, you might need an Establishment License if you're importing or distributing the device. This depends on your role in the supply chain.
4. FDA Certification: While FDA certification is valuable, it's important to note that Canadian regulations may differ from U.S. regulations. Compliance with FDA standards doesn't automatically ensure compliance with Health Canada requirements.
5. Compliance Requirements: Even without needing a license, you must ensure your product meets Canadian safety standards and labeling requirements.

Steps to take:

1. Review Health Canada's guidance on medical devices, particularly for Class I devices.
2. Consider consulting with a regulatory expert familiar with Canadian medical device regulations.
3. Ensure all product labeling and marketing materials comply with Canadian regulations.
4. Maintain records of safety testing and certifications provided by the manufacturer.
5. Engage with Amazon Seller Support: They can provide guidance on Amazon's specific requirements for listing medical devices and ensure you're compliant with platform policies.

For other sellers considering health-related products:

• Have you navigated the regulatory landscape for medical devices in Canada?
• What resources did you find most helpful in ensuring compliance?

Remember, while this information provides a starting point, regulations can be complex and subject to change. It's always best to verify current requirements directly with Health Canada or consult with a regulatory professional to ensure full compliance before listing your product. Additionally, staying in close communication with Amazon Seller Support can help you navigate any platform-specific requirements for these types of products.

Jurgen