How to Evaluate a Medical Injection Molding Supplier for Canada and Australia
Selecting a medical injection molding supplier can affect the manufacturing and quality evidence an OEM uses to support finished-device compliance. However, a contract molder does not automatically become the legal manufacturer, Canadian licence holder, importer or distributor, Australian sponsor, or ARTG applicant. The regulated entity remains responsible for determining the device classification, market-authorisation route, and applicable quality-system requirements. OEMs should evaluate a molder according to the outsourced process and the risk of the finished device. Relevant controls may include documented specifications, design-for-manufacturing review, material and lot traceability, inspection, process validation where required, nonconformance handling, change notification, record retention, and audit