Overview

Amazon.ca has removed its blanket ban on HIV self‑testing kits, allowing qualified third‑party sellers to list these devices on the Canadian marketplace. The policy shift takes effect immediately but comes with strict compliance obligations tied to Health Canada regulations. Sellers who ignore the new requirements risk listing removal, account penalties, and potential legal exposure, making careful preparation essential.

Key Points

• Eligibility limited to distributors — Only sellers who can prove Canadian distribution rights for medical devices may list HIV self‑test kits.
• Self‑test kits only — Products must be marketed for consumer self‑testing; professional‑use diagnostics remain prohibited.
• Full Health Canada compliance — Listings must contain all mandatory labelling, licensing numbers, and safety statements required by the Medical Devices Regulations.
• Documentation mandatory — Amazon will request proof of distributor authorization, product registration, and any applicable Health Canada licences before ungating the category.
• Enforcement is strict — Non‑compliant listings are subject to immediate removal, and repeated violations can trigger account suspensions or legal action.

How the New HIV Test Listing Process Works

1. Verify Distribution Rights — Confirm that your company holds a valid Canadian distributor licence for the specific HIV self‑test model. For example, a U.S.‑based importer must obtain a Health Canada registration number before it can be sold in Canada.
2. Gather Required Documentation — Assemble a packet that includes the Health Canada device licence, proof of registration under the Medical Devices Regulations, and any audit certificates (e.g., MDSAP) relevant to the device’s country of origin. Amazon will request these files during the ungating review.
3. Submit an Ungating Request — Use the “Add a New Product” workflow in Seller Central, select the medical device category, and upload the documentation package. Amazon’s compliance team reviews the submission, typically within 7‑10 business days.