Medical devices are also authorised or approved for direct sale to the consumer and are referred to as over-the-counter (OTC) products. Medical devices are also available from many online retailers. If you buy a device for home use over the Internet, make sure you buy from a reliable source. If you seek medical treatment through the Internet rather than through health professionals, you could be wasting valuable resources - your time and your money - because the treatments may be useless and your money wasted.
Only health products that have been authorised for "over-the-counter" or "home use" may be advertised and sold directly to consumers. If your medical supply business is already present online with a product catalogue or educational resource (probably built on a CMS), you need to migrate your website from a CMS to an e-commerce platform to enable online sales. However, the quality of health and medical product information on the Internet varies, and it is often difficult for the Internet user to identify the true source of the information and determine whether it is reliable, complete and up-to-date. Users who are uncomfortable with the possible use of their personal data should purchase their medical products through conventional, legitimate distribution channels.
Before purchasing a medical product through this channel, even if the product appears legitimate to you, contact your insurance or other health coverage organisation to find out whether the purchase would be covered and whether the online medical product provider is recognised by your insurer or health organisation. Neither the FDA nor the FTC requires the submission of medical product advertisements for pre-approval. By purchasing medical products over the Internet, you may lose the quality assurance provided by the authorised channels of manufacture, distribution and sale of medical products in your country. Medical products sold over the Internet may circumvent the regulatory protection offered by health authorities and your government.
The FDA is the primary agency with authority over the labelling, promotion and advertising of medical products. It facilitates the availability of medical equipment and supplies to people, including those in rural areas with limited access to health care. There are many health and medical sites on the Internet that provide good information that may not be readily available in other media. While these vendors are allowed to sell medical devices, the types of items they can market are restricted to those that are currently considered over-the-counter devices.
The FTC is responsible for regulating the advertising of many medical devices under sections 12-15 of the FTC Act, which prohibit false or misleading advertising of certain products regulated by the FDA3.Health authorities and organisations in each country can provide a list of sites with links to reliable sources of medical and health information. The ban on online sales applies to active implantable medical devices, in vitro diagnostic medical devices and Class III medical devices, as well as certain Class IIa and IIb products.