Medical Device UDI Management System

What is UDI

UDI (Unique Device Identification), also known as Medical Device Unique Identification, is a code composed of symbols, numbers, or letters, usually attached to medical device products and packaging. It is the most important part of the unique identification system for medical devices, with global uniqueness, and can be used for precise identification of medical device products, facilitating supervision and traceability. Therefore, it is also known as the "digital identity card" of medical device products.

Digital production (coding system) is aimed at production enterprises, using unique technologies such as industrial automation, intelligent recognition, multiple information encryption, and software and hardware system integration (optical, mechanical, electrical, and computer) to achieve product "one thing, one code", and to assign codes, collect, and establish product packaging relationships. It is the core product of the digital industry chain.

The significance of implementing UDI in medical institutions

1. Establishing a UDI system helps to strengthen the risk management of medical consumables in clinical use.

2. Accelerate circulation efficiency, replenish goods in a timely manner, reduce inventory, reduce the cost of human error correction, and prevent and eliminate potential loopholes.

3. Addressing the shortcomings of traditional human regulatory methods can help ensure the safety of consumables, the reliability of hospital circulation, and the safety of consumer use.

UDI Management System Function Module

1. Functional management

Develop a procurement plan, and after approval, proceed with product distribution

2. Inspection management

Product quality inspection, based on the inspection results, products are stored or exchanged. If there are problems or defects during product inspection, returns or exchanges can be made.

3. Warehouse management

Capable of inspecting qualified products for entry and exit, as well as creating or removing multi-level packaging associations

4. Enterprise Management

Create and maintain basic information and product supply contracts for each supplier. Create and maintain qualifications for medical institutions and suppliers, including business licenses, production and operation permits, etc

5. Traceability platform

Medical device full lifecycle process supervision, UDI service platform achieves complete product data chain traceability through UDI data, assisting enterprises in quickly and efficiently establishing a traceability platform that meets the requirements of national market supervision and the supervision of medical devices by the National Medical Products Administration.