美国食品和药物管理局的UDI要求与体现
非会员费用: 港币 1,800元
为期半天的培训讲解美国食品和药物管理局(FDA)在2013年9月发布的"医疗器械唯一标识"(Unique Device Identification (UDI))的规例。帮助生产商应对其要求/规例以支持病人的安全和供应链安全。
查询: 王小姐 - 电邮: training@gs1hk.org
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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
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