Understanding the US FDA UDI Requirement and Implementation

Technology increasingly plays a vital role in improving patient safety and device surveillance. To identify the device more accurately and improve the data capture for better patient experience and medical device innovation, the US Food and Drug Administration (FDA) released a new rule of Unique Device Identification (UDI) in September 2013, which establishes that a common, worldwide system for product identification is required to apply onto all medical devices and device packages placed in the US market, unless excepted. 

• A unique device identifier number should be assigned by the device manufacturer to each version or model of a device
• The unique device identifier should be both in human readable format and in AutoID format. By default, this information will be applied on the label of each device uniquely identified.

Why GS1?

GS1, a leading non-profit, global standards organisation, is accredited by the US Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs). Global GS1 Standards meet the government’s criteria for UDIs and will help manufacturers to address requirements of the new FDA UDI regulation to support patient safety and supply chain security.

Date:              3 August 2016 (Wed)
Time:               2 to 5:30pm
Fee:                 Member           HKD 1500 
                        Non-member  HKD 1800
Instructor:       Mr. KK Suen, Chief Architect & Principal Consultant, GS1 Hong Kong
Language:       Cantonese

For enquiry, please contact training@gs1hk.org