Drugdu.com expert's response:

The Unique Device Identifier (UDI) is a core tool in the international regulatory landscape for medical devices, designed to enable precise traceability and management throughout the entire lifecycle of medical devices via standardized coding. Its core components, implementation logic, and value are outlined below:

I. UDI Composition: Dual-Code Synergy for Precise Identification

The UDI consists of two parts—the Device Identifier (DI) and the Production Identifier (PI)—forming a "static + dynamic" dual-recognition system:

Device Identifier (DI): Serves as the foundational identity code for medical devices, encompassing registrant/filing entity information, model specifications, and packaging hierarchy. For example, the DI of a specific brand of cardiac stent uniquely identifies its manufacturer, product model, and packaging format (e.g., single unit or boxed). The DI remains stable once assigned, ensuring traceability of basic product information.

Production Identifier (PI): Acts as the dynamic information code for medical devices, covering production batch numbers, serial numbers, manufacturing dates, expiration dates, etc. For instance, cardiac stents under the same DI can be distinguished by their PIs to track individual products or batches from production to use.

II. UDI Implementation Logic: Phased Rollout for Full-Chain Coverage

UDI implementation adheres to a "categorized management, gradual promotion" principle, covering the entire lifecycle of medical devices—from design and production to distribution and use:

Regulatory Drivers: China introduced the Rules for the Unique Device Identification System of Medical Devices in 2019, mandating UDI adoption. Currently, all Class III medical devices are fully compliant with UDI requirements. Starting June 1, 2024, UDI implementation expanded to 103 types of Class II devices (e.g., ultrasonic surgical equipment, diagnostic X-ray machines), with Class I devices to be gradually included.

Stakeholder Responsibilities: Manufacturers: Must generate UDIs and upload them to the National Medical Products Administration (NMPA) database, ensuring data authenticity, accuracy, and traceability. For example, a manufacturer producing cardiac stents must input both DI and PI data into the system for subsequent tracking.

Distributors: Scan UDIs during inventory intake and dispatch to enable traceability in the distribution chain.

Healthcare Providers: Record UDIs during clinical use and billing to ensure transparency in product utilization.

Technological Carriers: UDIs are encoded via barcodes, QR codes, or radio-frequency identification (RFID) tags, supporting both automated and manual recognition. This compatibility with existing information systems reduces implementation costs.

III. UDI Core Value: Enhancing Safety and Optimizing Management

UDI implementation significantly improves medical device regulation and industry efficiency:

Patient Safety Assurance:

Rapid Recall: If a batch of cardiac stents exhibits quality issues, healthcare providers can swiftly locate and remove affected products using UDIs, minimizing patient risks.

Counterfeit Prevention: UDIs help identify fake products or compatibility issues (e.g., allergic reactions to latex materials in MRI devices), reducing medical incidents.

Industry Efficiency Gains:

Inventory Management: Healthcare providers leverage UDIs for precise inventory audits, preventing the use of expired products.

Supply Chain Optimization: Distributors achieve coded inventory intake/dispatch via UDIs, enhancing logistical efficiency and lowering operational costs.

Regulatory Capacity Strengthening:

Full-Lifecycle Traceability: Regulatory authorities can track every stage of a product’s lifecycle—from production to use—through UDI databases, combating illegal circulation.

Data-Driven Decision-Making: UDI-generated big data supports policy formulation and risk assessment, driving industry standardization.

Global UDI Practices: International Standards, Chinese Solutions

UDI has become the "universal language" of international medical device regulation:

International Framework: The International Medical Device Regulators Forum (IMDRF) developed the Proposed Rules for the Unique Device Identification System, promoting global UDI standardization.

Chinese Implementation: China established a UDI database requiring registrants/filing entities to upload data and facilitated data sharing with medical insurance and health authorities. For example, Yunnan Province built a UDI traceability management system covering manufacturers, distributors, and healthcare providers, forming a provincial-level traceability repository.

IV. Case Studies: Demonstrating UDI’s Practical Efficacy

Case 1: A Class III medical device manufacturer achieved full-lifecycle product traceability through UDI. During a recall, the company located and removed defective cardiac stents nationwide within 24 hours, mitigating patient risks.

Case 2: A healthcare provider managed high-value consumables (e.g., cardiac pacemakers) via UDI, enabling "one-item, one-code" precise billing and reducing medical insurance fraud risks.