Amazon now allows the sale of Class II Medical devices if they comply with all the requirements set by Health Canada.

To comply with the regulations and to ensure that your class II Medical device listings are not removed, you must submit one or more of the following as applicable:

1. Medical Device Licence (MDL) OR Health Canada Authorization and Device Identifier
2. Medical Device Establishment Licence (MDEL)

Steps to Submit Compliance Information

To submit MDL compliance information for a single product, complete the following steps:

1. Go to Inventory and select Manage All Inventory.
2. Find the listing you want to edit, and select Edit from the drop-down menu for that listing.
3. In the new tab that pops up, navigate to the Compliance tab to find the compliance regulation type at the bottom of the page.
4. Select Medical Device License number and submit the applicable license number in the Regulatory identification field.
5. Click on “Add more” located below Compliance regulation Type drop-down field and select Device Identifier to submit the device identifier number in the Regulatory identification field.
6. Click Save and finish.

To submit MDL compliance information for multiple products, complete the steps below.

1. Go to Inventory, select Add Products via Upload, and click the Download inventory file tab.
2. Identify the applicable categories and sub-categories from the Search tool or the Product classifier that is located in the Step 1: Select the types of products you want to sell section.
3. Click Select to add the categories to the inventory file template.
4. In the Step 2: Select the type of template section, either select Custom mode or Advanced option.

• If you selected Custom mode, select the Basic and Compliance attributes from the available attribute groups options.

• After Basic and Compliance attributes are selected, click Add to selected attribute group.

1. Click Generate template. This will generate an excel spreadsheet.
2. Open the excel spreadsheet. In the template tab, enter the SKUs that need to be updated in the item_sku column.

Important: Select partial_update from the drop-down options in the update_delete column.

1. Navigate to the Compliance regulation type and Regulatory identification columns in the Safety and compliance section.
2. For each product, select the Medical Device License number and Device Identifier from the drop-down in the Compliance regulation type.
3. For each product, submit the applicable ID number in the Regulatory identification field for the Medical Device License number and Device Identifier.
4. After you build your inventory file, save the file either as tab-delimited text (.txt) or excel (.xls) format.
5. Go to the Inventory tab, select Add Products via Upload, and click on the Upload your inventory file tab.
6. Complete the fields in the Upload file section and click Upload.
7. Click the Monitor upload status tab. The date, time, batch ID, status and results of your most recent upload are displayed here.
8. Click Download your processing report to review the processing report after each upload. If your processing report shows errors, modify your inventory file and upload the file again.

If you are required to hold an MDEL to sell medical devices in Canada, complete the following steps to submit MDEL compliance information:

1. To determine if you are required to hold an MDEL, please see the section above.

2. If applicable, please provide your MDEL to rp-med-devices-document-submission@amazon.ca, with the following information:

• Put "MDEL for Medical Devices" in the subject line;

• Attach your MDEL document from Health Canada.

3. If not-applicable, please confirm that you are the product manufacturer to rp-med-devices-document-submission@amazon.ca, with the following information:

• Put "MDEL for Medical Devices" in the subject line;

• Please provide documentation to confirm address.

For more details, refer to the Help Page - Medical devices and accessories

The impacted sellers will also be notified via an email to provide the compliance information needed along with the list of ASINs.

If the provided product information has been determined to be invalid, or if no corrective action has been completed, your listings may be removed from the Amazon Canada store without further notice to you.