非會員費用: 港幣 1,800元
為期半天的培訓講解美國食品和藥物管理局(FDA)在2013年9月發布的"醫療器械唯一標識"(Unique Device Identification (UDI))的規例。 幫助生產商應對其要求/規例以支持病人的安全和供應鏈安全。
查詢: 王小姐 - 電郵: firstname.lastname@example.org
有興趣人士請於2016年7月27日或之前於此網詀登記，我們將在活動前3個工作天發出確認電郵予成功預留座位之人士，並請以劃線支票支付報名費用，郵寄至「香港灣仔告士打道160號海外信託銀行大廈22樓 GS1 Hong Kong」。支票抬頭請註明「GS1 Hong Kong Ltd」，背面請填上貴公司的名稱及聯絡電話，並註明「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.
- 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.
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
For enquiry, please contact email@example.com
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)