How to Get Selling Medical Devices Online Right
Online sales of devices such as monitors, mobility aids and diagnostic products.
Marcus Adeyemi
What is at stake
Device sales involve regulated claims, prescription requirements for some products and after-sales obligations.
The playbook
- Confirm classification and prescription status per product
- Keep product claims within cleared indications
- Provide instructions for use online
- Build an adverse event reporting route
- Review listings with regulatory staff
Where it goes wrong
Avoid:
- Selling prescription devices without controls
- Claims beyond cleared uses
- Missing instructions for use
- No process for complaints and adverse events
The numbers behind it
| Measure | Figure |
|---|---|
| Classification | devices fall into classes with different requirements |
| Prescription devices | some devices require a prescription |
| Claims | marketing must stay within cleared uses |
| Reporting | adverse events have reporting obligations |
Getting outside help
When to hand it over: Bring in help before listing regulated devices.
Where this comes from
- U.S. Food and Drug Administration — Medical device advertising and promotion
- Federal Trade Commission — Health Products Compliance Guidance
The figures and practices above come from the sources listed.
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Where to go next
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