Medical devices

The content below is for guidance only, and you should not take it as a substitute for legal advice. We encourage you to consult your legal counsel for any concerns about the laws and regulations concerning your product. Amazon reserves the right to remove any listing it considers to be inappropriate for sale for any reason.

Examples of Permitted Listings

Reminder: All listings and products must comply with all applicable laws and regulations.

• Certain medical devices that do not require medical prescription or assistance by a health care provider, and provided they are manufactured in compliance with the law, appropriately described and labeled and not otherwise restricted, such as:
  • Contact lenses
  • Breathalyzers
  • Oxygen concentrators
  • Pulse oximeters
  • Heart rate monitors
  • Defibrillators
  • Q-ray bracelet
  • DNA tests or paternity tests
  • Pregnancy tests
  • Syringes without needles
  • Tattoo kits
  • Piercing kits
  • Tanning devices
  • Coronavirus antigen tests (provided the products are for self-testing by laypersons and approved by the BfArM). To list these products, contact us via covid-listing-approval-de@amazon.com and provide the following data:
    • merchant token (LINK)
    • merchant name
    • e-mail address
    • phone number
    • test name
    • ASIN (if known)
    • manufacturer
    • BfArM special approval file number
    • BfArM AT number
    • real product image as well as image of the packaging showing the approval number and the instructions for self-use
    • complete instructions for use of the medical device, including instructions for self-use
    • copy of the invoice for the product
    • a photo showing invoice and product together

Examples of prohibited listings

• Devices that claim to predict gender of unborn babies
• Zappers
• Prescription eyewear
• Hearing aids
• Used medical devices
• Implantable devices
• Products that require a prescription, a medical professional's supervision or direction for their use
• Medical devices for professional use
• Products intended to restrain the movement of a person with disability, dementia or other medical conditions
• Needles sold alone or included in other devices
• Stents and shunts
• Catheters
• Dialysis equipment
• Phototherapy devices for the treatment of skin disorders
• Surgical equipment such as clamps and lasers
• Orthopedic nails and plates
• Bone saws, blood lancets, excavators and chisels
• Reamers
• Pacemakers
• Ultrasound devices, fetal Doppler
• X-Ray equipment
• CT scanner, MRI scanner
• Blood transfusion equipment
• Anesthesia machines
• Apnea monitors
• Resuscitators
• Tracheal tubes
• Feeding pumps, infusion pumps and intra-aortic balloon pumps
• Ophthalmoscopes, refractors
• Neuro-endoscopes
• Incubators
• Suction equipment
• Dental bridges, crowns, ceramics and polymers, and other dental equipment
• Dental alloys, burs and filling materials
• Pulp testers

Related Amazon Help pages

• Restricted products: Drugs, drug paraphernalia and dietary supplements
• Categories requiring approval

Additional Useful Information

• EU
• European Commission website with information on EU regulations on medical devices: http://ec.europa.eu/health/medical-devices/regulatory-framework/index_de.htm
• Medical devices act: http://www.gesetze-im-internet.de/mpg/
• BfArM website on antigen tests for SARS-CoV-2: https://www.bfarm.de/EN/MedicalDevices/AntigenTests/_node.html

• UK
• Website of the Medicines and Healthcare Products Regulatory Agency (MHRA): http://www.mhra.gov.uk/#page=DynamicListMedicines
• UK General information: https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety
• UK helpdesks: https://www.gov.uk/guidance/contact-mhra
• Brexit guidance can be found here: Regulating medical devices in GB and NI from 1 January 2021
• Business Companion website that contains guidance on UK product compliance rules: https://www.businesscompanion.info/en/get-started