What is UDI?

UDI stands for Unique Device Identification, which is used to identify medical devices for tracking and management purposes throughout manufacturing, distributing, and products in use processes.

What is the purpose of UDI?

The purpose of UDI is to help identify, track, and manage medical devices, improve product quality and safety, promote traceability and tracking of medical devices, and reduce the risk of harm to patients.

If we already have an existing product numbering system, do we need to create a new UDI?

If you already have an existing product numbering system, you may need to combine it with UDI, or create a new UDI if necessary. It depends on whether your existing system is UDI compliant.

What kinds of medical devices are included?

UDI regulations require ALL medical devices to be labeled with UDI, including medical equipment, diagnostic products, surgical tools, dental supplies, reagents, medical supplies, etc.

What are the ways to mark UDI?

There are two ways to mark UDI: direct marking and indirect marking. Direct marking refers to marking the UDI code directly on the medical device, while indirect marking involves placing the UDI code on labels or packaging.

If my product is a set product, does each individual product need a UDI?

If your product is a set product, each individual product requires a UDI. For example, each tool in a surgical tool set product needs to be marked with a UDI.

What impact does UDI implementation have on manufacturers?

UDI implementation requires manufacturers to make corresponding adjustments, such as redesigning product labels, updating manufacturing procedures, establishing UDI managing database, etc., as well as requiring corresponding technical, resource, and financial support. However, implementing UDI can also improve product competitiveness, reduce risk, and help improve quality and safety.

What information is included in UDI labeling?

UDI labeling must include specific information such as the manufacturer's name, product name, specifications, manufacturing date, expiration date, serial number, batch number, etc.

How is UDI labeling carried out?

UDI labeling methods include direct printing, labeling, engraving, and other methods, but compliance with relevant standards are required.

What are the benefits of UDI labeling?

UDI labeling can improve the safety and management efficiency of medical devices, assist in tracing adverse issues and conducting recalls, and provide consumers with complete product information.