Are there any imitations of Class III medical devices?

Yes Due to the complexity of the production, sale and use of the three types of medical devices, there are indeed some illegal, counterfeit and shoddy medical devices in the market. The third category of medical devices refers to high-risk medical devices, which need to be approved and registered by the US Food and Drug Administration before they can be marketed. The production, sale and use of such medical devices need to comply with strict laws, regulations and standards.