NMPA Information Center Opens Public Consultation on 3 UDI Technical Guidelines

The National Medical Products Administration Information Center officially released three draft guidelines on Unique Device Identifier (UDI) typical applications on July 24, 2026, covering Registrants/Filers & Manufacturers, Distributors, and Medical Organizations.

Public comment period: July 24 – August 23, 2026.

Key Highlights of the Three Guidelines

1. For Registrants/Filers & Manufacturers

l Focuses on UDI implementation in production quality management. Key scenarios include:

l Design & Development: Assign UDI-DI at the design stage; build product master data.

l Production Quality Control: Integrate UDI into work orders; establish product traceability records.

l Product Release: Include UDI coding verification in release procedures.

l Warehousing: Use UDI scanning for inbound inspection and inventory counting.

l Sales & After-Sales: Conduct sales records and after-service tracking with UDI.

l Analysis  Improvement: Include UDI in adverse event and recall records.

2. For Distributors

Focuses on UDI implementation in distribution quality management. Key scenarios include:

l Procurement, Receiving & Inspection: Build UDI-DI master data; use scanners for receiving.

l Warehousing & Storage: Include UDI and packaging hierarchy in inbound warehousing records.

l Sales, Outbound & Transport: Include UDI in sales and outbound verification records.

l After-Sales: Include UDI in return records; support recall and adverse event reporting.

l Traceability: Integrate receiving, warehousing, and outbound records via UDI.

3. For Medical Organizations

Focuses on UDI implementation in usage quality management. Key scenarios include:

l Procurement, Receiving & Inspection: Build UDI-DI master data; verify with scanners.

l Warehousing & Storage: Include UDI in inbound records; link UDI with temperature/humidity logs.

l Usage & Maintenance: Include UDI in implant records and maintenance logs.

l Traceability: Integrate receiving, warehousing, outbound, and usage records via UDI.

How to Submit Feedback?

Complete the feedback form and email to: liuliang@nmpaic.org.cn, with subject line: “Feedback on UDI Typical Application Technical Guidelines Standards — [Your Name/Organization]”.

These guidelines will significantly advance UDI implementation across the healthcare ecosystem. Whether you're a manufacturer, distributor, or healthcare provider, this is your chance to shape the future of medical device traceability in China!