会员费用 : 港币 1,500元
非会员费用 : 港币 1,800元

查询: 王小姐 - 电邮: training@gs1hk.org

有兴趣人士请于2016年7月27日或之前于此网詀登记,我们将在活动前3个工作天发出确认电邮予成功预留座位之人士,并请以划线支票支付报名费用,邮寄至「香港湾仔告士打道160号海外信托银行大厦22楼GS1 Hong Kong」。支票抬头请注明「GS1 Hong Kong Ltd」,背面请填上贵公司的名称及联络电话,并注明「Understanding the US FDA UDI Requirement and Implementation」。

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. 

  • 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

To provide the industry stakeholders a structured framework and methodology in fulfilling this regulation, in this half day training, the instructor will cover:

  • Unique Device Identifier (UDI) Basic:
    - Structure of UDI (= DI + PI)
    - What is Device Identifier (DI)?
    - What is Production Identifier (PI)?
  • 3 Steps for Manufacturer to comply with FDA UDI requirements:
    - Numbering mechanism
    - Labeling requirement
    - Data upload to FDA database - Global Unique Device Identification Database (GUDID)
  • Exceptions

地点

湾仔告士打道160号海外信托银行大厦22楼

前往方法

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