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

• Certain medical devices that do not require medical prescription nor assistance by a health care provider, and provided they are manufactured in compliance with law, appropriately described and labeled and not otherwise restricted, such as
  • Breathalyzers
  • Contact lenses for cosmetic purposes
  • Readymade monofocal glasses that do not exceed +3.50 dioptres
  • Pulse oximeters
  • Pulse Heart Monitors
  • Q-ray bracelet
  • Oxygen concentrators
  • Blood glucose tests
  • Fertility tests
  • Pregnancy tests
  • Insulin pump
  • Electrical Muscle Stimulation (EMS) units
  • Tattoo kits
  • Piercing kits
  • Tanning devices
  • Outdoor medical kits that do not contain any prohibited component

Examples of Prohibited Listings

• Used medical devices
• Products that require a prescription or a medical professional's supervision or direction for their use, e.g.:
  • Corrective eyeglasses and glasses on prescription
  • Progressive glasses and multifocal glasses
  • Readymade glasses that exceed +3.50 dioptres
  • DNA tests or paternity tests
  • Continuous Positive Airway Pressure (CPAP) devices and accessories
  • Silicone implants
  • Circumcision kits
• Products intended to restrain the movement of a person with disability, dementia or other medical condition
• Devices which claim predicting gender of unborn babies
• Anesthesia machines
• Apnea monitors
• Blood transfusion equipment
• Bone saws
• Catheters
• Dental bridges, crowns, ceramics and polymers
• Dental alloys, burs and filling materials
• Rotary scalers and ultrasonic scalers for professional-use and/or for home-use
• Dialysis equipment
• TENS Machines
• Excavators and chisels
• Eye electromagnets
• Hearing aids
• Implantable devices
• Incubators
• Needles sold alone or included in other devices
• Neuro-endoscopes
• Orthopaedic nails and plates
• Pacemakers
• Phototherapy devices intended for treating skin disorders
• Pulp testers
• Reamers
• Refractors
• Stents and shunts
• Suction equipment
• Surgical equipment such as clamps and lasers
• Tracheal tubes
• X-Ray equipment
• Zappers

Related Amazon Help Pages

• Restricted Products: Drugs, Drug Paraphernalia and Dietary Supplements
• Categories and Products Requiring Approval: Health & Personal Care
• For further information for the sale of Defibrillators: Recalls & Product Safety

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_en.htm

• 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, which contains guidance on UK product compliance rules: https://www.businesscompanion.info/en/get-started