On April 16, 2026, new mandatory compliance regulations officially took effect on Amazon’s U.S., Canadian, and European sites.

Unlike previous “reminder-based” policies, these new regulations are strictly enforced: there are no exemptions, they cover core high-risk categories, the review standards are rigorous, and they directly impact product listing privileges and store performance.

These new regulations do not cover all product categories comprehensively but instead focus on three high-risk consumer categories, implementing mandatory compliance reviews. If your store’s products fall under the following categories, you must complete the compliance review regardless of sales volume or the length of time your store has been active; otherwise, you will not be able to sell normally.

1. Safety-critical products:

You must provide a safety test report issued by an ISO 17025-certified laboratory that is valid for one year. Additionally, product labels and instructions must comply with local safety standards.

2. Over-the-counter oral medications: On the U.S. and Canadian sites, you need FDA approval documents, an NDC (National Drug Code), Child-Resistant (CR) packaging test reports, and proof of ingredient safety; For the European sites, CE certification, relevant drug registration documents, and proof of GMP (Good Manufacturing Practice) compliance are required. Additionally, there are general requirements, including an ISO 17025 testing report, a complete list of ingredients, and compliant labels and instructions.

3. Medical Devices: On the U.S. site, an FDA marketing authorization (510(k)), medical device registration certificate, product instructions, and label compliance documents are required; For the European marketplace, CE certification, MDR/IVDR compliance certificates, technical documentation, and declarations of conformity are required. General requirements include ISO 17025 safety and performance test reports and proof of a quality management system for production. Amazon’s decision to raise compliance thresholds for these three major categories is both an inevitable result of increasingly stringent global regulations on medical and safety products and a crucial measure by the platform to mitigate compliance risks and ensure consumer safety.