Amazon Medical Devices Requirements

Medical Devices Sold on Amazon Must Adhere to Amazon’s Seller Policies in Order to Remain Compliant

If you intend to sell your medical devices on Amazon you first must follow all requirements as set forth by the Food and Drug Administration.

Amazon specifically states that your product must:

  • Be registered with the FDA (have a Device registration and listing)
  • Have 510(k) Clearance if Class I or Class II
  • Have Class III Pre-Market Approval (PMA)

Amazon policies also require that you:

  • Must follow all applicable labeling requirements
  • Must not be the subject of an existing warning letter

dicentra provides the following services to help you get your medical device ready for listing on Amazon

  • Assist with device registration
  • Assist with 510(k) Clearance
  • Liaison directly with regulatory bodies and respond to questions
  • Medical Device Reporting
  • Label Development & Review
  • Medical Device Clinical Trials
  • Product Claim Substantiation
  • Adverse event reporting

Contact us using the form below to ensure your Medical Device is compliant with all of Amazon’s Seller policies