Defibrillators
If you list products on Amazon, you must comply with all applicable laws, regulations, standards and our policies related to those products and product listings.
Defibrillators covered by this policy
A defibrillator is a medical device that applies an electric charge or current to the heart to restore a normal heartbeat. If the heart rhythm stops due to cardiac arrest, also known as sudden cardiac arrest (SCA), a defibrillator may help it start beating again.
Our policy for defibrillators
Amazon requires that all defibrillators have been tested to and comply with the regulations, standards and requirements listed below:
| Product | Regulations, standards and requirements |
|---|---|
| Defibrillators |
|
You must submit the following:
Documents:
- EC (European Commission) type-examination certificate that shows that the product complies with the regulations, standards and requirements listed above
- A document issued by the manufacturer that proves the product is intended for consumers; this could be part of the instruction manual or a separate declaration from manufacturer
Images:
- Model, part or item number
- Name and address of manufacturer, importer, distributor or authorised representative
- Brand name
- Product labels
- Compliance markings
- Hazard warnings
- Product instructions and manuals
- CE or UKCA mark
- For Northern Ireland, CE mark (plus UKNI marking, if you used a UK-notified body to carry out a mandatory third-party conformity assessment)
When you submit images or documentation with images, ensure the following:
- Images are clear and legible
- Images demonstrate that the product is the same as the product tested and listed on the product detail page
- Product instructions, manuals, safety information, labels and warnings are in the language of the intended country of sale
- If the product is a set or bundle, provide images for each product included
Customer safety is our top priority. We reserve the right to ask for additional information to verify product safety and compliance at any time.
Compliance services
If you need help getting compliance certifications, testing and audits, use our Service Provider Network.
Submit information
To submit documents or appeal a compliance requirement, go to Submit compliance documents or appeal a documentation request.
Policy violations
If you don’t provide the required information (listed above) upon request, we reserve the right to take any further actions in accordance with the Amazon Services Business Solutions Agreement, including, but not limited to, removing the relevant product listings.
Resources
- Amazon Services Business Solutions Agreement
- Remove inventory overview
- Fix stranded inventory
- EU and UK Product Compliance Guidance – CE and UKCA Marking
- ISO 17025 International Organisation for Standardisation
Disclaimer: The information provided on this page does not and is not intended to constitute legal advice. All information, content and materials available on this site are for general informational purposes only.
