Unique Device Identification (UDI) for medical devices is a series of numbers, letters or characters created by globally recognised device identification and coding standards, which includes Device Identification (DI) and Production Identification (PI), used to uniquely identify a medical device, and is regarded as a unique ‘identity card’ for medical device products in the supply chain. UDI is regarded as the only ‘identity card’ for medical device products in the supply chain.

For new customers, product registration and listing services are provided at a fee; for existing customers (assisted by our 510(k) agent registration), product registration and listing services are provided free of charge.

When a product is determined to be a medical device in Canada, it is necessary to submit information to Health Canada (Health Canada) for registration; it is worth noting that it is sufficient to apply for an MDEL for Class I medical devices in Canada, and an MDL for Class II, Class III, and Class IV (the applicant must have a certificate of MDSAP accreditation).

According to the requirements of the US FDA, manufacturers (including OEM processors) exporting finished and semi-finished medical devices to the US market should register their businesses in the US FDA system.