Month: October 2026

The United States is a major market for medical devices and diagnostic products, and many manufacturers source injection-molded components internationally. When molded medical parts are imported into the U.S., their regulatory treatment depends largely on whether they are components intended for further manufacturing or finished medical devices ready for commercial distribution. This article breaks down the complex regulatory requirements for importing medical device components into the US. The Dual Regulatory Framework For Importing Medical Molded Parts Into The US Two separate authorities govern the entry of medical molded parts into the United States. The first is the US Food and