Hello @Seller_xYjiQI8nhkYY2,

Thank you for your question about filing a Medical Device Establishment License (MDEL) for a Class I medical device and using Amazon's fulfillment services. This is a complex area where e-commerce intersects with health regulations.

While I can't provide specific legal advice, here are some general points to consider:

1. MDEL Requirements:

• MDELs are typically required for companies importing or distributing medical devices in Canada.
• Class I devices generally have lower regulatory burdens compared to higher classes.

2. Amazon Fulfillment and Compliance:

• Amazon's fulfillment centers are designed to handle a wide variety of products, but they may not be specifically set up for medical device handling.
• It's important to verify if Amazon's processes meet Health Canada's requirements for storage and distribution of medical devices.

3. Inspections:

• Health Canada may require inspections of storage facilities, which could be challenging in an Amazon fulfillment center setting.

Steps you might consider:

1. Contact Amazon Seller Support:

• Inquire about their policies and capabilities regarding the storage and handling of Class I medical devices.
• Ask if they have experience with Health Canada inspections or MDEL compliance.

2. Consult with Health Canada:

• Reach out to Health Canada for guidance on using third-party fulfillment for medical devices.
• They may have specific requirements or recommendations for this situation.

3. Seek Legal Advice:

• Consider consulting with a lawyer specializing in Canadian medical device regulations.

For other sellers:

• Has anyone successfully navigated MDEL requirements while using Amazon fulfillment for medical devices?
• What strategies have you found effective for ensuring regulatory compliance in e-commerce for medical products?

Remember, compliance with health regulations is crucial. While Amazon's fulfillment services offer many benefits, ensuring they align with specific medical device regulations is essential for your business's legal and ethical obligations.

If you find a solution or receive clarification from Health Canada or Amazon, please consider sharing your experience here. It could be valuable information for other sellers in similar situations.

Jurgen