Day: September 3, 2026

China can offer EU medical device companies competitive tooling costs, experienced mold engineering and scalable injection molding capacity. However, successful sourcing depends on more than price, factory size or quoted lead time. Buyers must verify that the supplier’s quality-system scope matches the project, define regulatory and quality responsibilities, control materials and manufacturing changes, and document tooling and intellectual property ownership. This guide explains seven areas that EU medical device companies should evaluate when sourcing injection molds or molded medical components from China, along with practical controls to reduce associated risks. Why Supplier Quality Controls Matter A McKinsey study estimated that