Under the EU CE MDR, products requiring review by a Notified Body (NB) include: Class I (Is, Ir, Im), Class II (Class IIa and Class IIb), and Class III; after the preparation of technical documents for Class I (excluding Is/Ir/Im), they should be submitted to the EU representative for filing. Under the EU CE IVDR, products requiring review by a Notified Body (NB) include: Class A (sterile), Class B, Class C, and Class D; after the preparation of technical documents for ordinary Class A, they should be submitted to the EU representative for filing.

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.

The US FDA 510(k) registration does not apply to: Class I exempted products and Class II exempted products.

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.

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

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).