陳維斌 , 亞洲區業務協理生命及醫療健康科學事業 Nov, 2013

醫療產品驗證規範 行動醫療標準陳維斌, 亞洲區業務協理生命及醫療健康科學事業 Nov, 2013

Agenda • 醫療器材法規架構 • 何為行動醫療? • 法規關注範圍 • FDA相關指引 • 範例 • Q&A

Government Regulatory Authority Certification Body Quality System Electrical Safety Risk Management Essential Performance Function Accuracy Stability …etc. etc. EMC Software Validation Biocompatibility Radiation Safety Sterilization 醫療器材法規架構

國別相關法規/文件分級原則分級上市審查要求第一類常規管理市級政府藥品部審查 China 醫療器械監督管理條例 , , , , . 第二類應予以適當管理省自治區直轄市政府藥品部門審查臨床驗證品質系統第三類 , , 嚴格管制國務院藥品部門審查臨床驗證部分產品須安全認證 USA FD&C Act Section 513 I 一般管制一般管制 , II , 一般管制特別管制一般管制特別管制 , III , 一般管制上市前許可一般管制上市前許可 EU Medical Device I Annex 7 低風險 Directive Annex IX IIa Annex 2, 3+4, 3+5, 3+6, 7 中低風險 IIb Annex 2, 3+4, 3+5, 3+6 中高風險 III Annex 2, 3+4, 3+5 高風險 Canada GD006 / RevDR-MDB I 低風險 II GMP 中低風險 III , GMP 中高風險上市前審查 IV , GMP 高風險上市前審查 Japan 827 I GMP 醫藥發字第號輕度危害醫療用具 II , ( ) 中度危害品質系統上市前核准部分免除 III , , ( ) 嚴重危害品質系統上市前核准臨床資料部分免除 IV , , 威脅生命品質系統上市前核准臨床資料 Australia Registable , GMP Australian Medical Device 依據個別產品考慮上市前審查 Regulation version 4 Listable , GMP 廣告與標示管制部分低風險 8903425 I ( ) Taiwan 衛署藥字第號醫療器材優良製造規範部分免除中風險 , ( ) 醫療器材優良製造規範查驗登記部分免除 II 高風險 , , 醫療器材優良製造規範查驗登記臨床相關資料 III 醫療器材管制分類

法規執行單位

相關評估要項 • 產品審查 • 安全性評估 • 電氣安全：IEC 60601-1,適用普通醫療和牙科設備 • IEC 61010 標準，適用 IVDs 或清潔器和消毒設備 • 電磁相容性：IEC 60601-1-2 電磁要求；放射性 (EMI) 和免疫性(EMS) • 幅射等級：IEC 60601-1-3 • 軟體確效：IEC 60601-1-4，可程式化器材 • 生物相容性：ISO 10993-1，生物學評估 • 風險管理：ISO 14971，風險管理應用 • 滅菌處理：ISO 11737 • 有效性評估 / AAMI, ANSI 或 ASTM 等協會所公佈的產品標準 • 功能評估 • 效能評估 • 品質系統審查/ ISO 13485, ISO 9001, EN46001

General Standard Collateral Standards 60601-1-1 60601-1-2 60601-1-3 60601-1-4 60601-1 Medical Systems EMC Radiation Protection Software 60601-2-1 Medical Electron Accelerators 60601-2-2 High Frequency Surgical Equipment 60601-2-38 Electrically Operated Hospital Beds 60601-2-50 Infant Phototherapy Equipment Particular Standards 產品電氣安全標準

何為行動醫療? • 結合行動科技與醫療照護服務的相關應用. • 透過使用行動設備為病患提供監測與照護的醫療服務. • 透過各種行動通訊技術及設備，使患者可以隨時隨地獲得醫療服務與資源. Resources: http://www.aalto.fi/en/current/news/view/2012-06-11/

Government Regulatory Authority Certification Body Quality System Electrical Safety Risk Management Essential Performance Function Accuracy Stability …etc. etc. EMC Software Validation Biocompatibility Radiation Safety Sterilization 法規關注範圍 Resources: http://www.mhealthjournal.com/196623/mhealth-summit-ivt-tech-demo/

FDA 相關指引 • Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software • Document issued on: January 14, 2005 • Background • This guidance outlines general principles that we consider to be applicable to software maintenance actions required to address cybersecurity vulnerabilities for networked medical devices—specifically, those that incorporate off-the-shelf (OTS) software. The guidance is organized in question-and-answer format, providing responses to questions that have frequently been posed to FDA staff. The “I” in the questions and the “you” in the answers are intended to apply to device manufacturers who incorporate OTS software in their medical devices. • The QS regulation, 21 CFR Part 820, applies to software maintenance actions. In addition, FDA has issued several guidance documents on software, including: • General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002. • Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, September 9, 1999. • Guidance for FDA Reviewers and Industry, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 29, 1998.

FDA 相關指引 • Radio-Frequency Wireless Technology in Medical Devices • This guidance document is being distributed for comment purposes only. • Document issued on: January 3, 2007 • Scope • This draft guidance document addresses issues and concerns pertinent to the safe and effective use of radio frequency (RF) wireless technology in medical devices, including: • wireless coexistence • performance • data integrity • security • electromagnetic compatibility (EMC). • Since these issues affect all stages of the product life cycle, FDA recommends they be considered in: • identification, documentation, and implementation of product design requirements (21 CFR 820.30) • design verification and validation (21 CFR 820.30) • risk management processes and procedures.

FDA 相關指引 • Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications • Document Issued on: July 21, 2011 • This guidance document is being distributed for comment purposes only. • The Food and Drug Administration (FDA) is issuing this draft guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or "mobile apps"). • Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority. At this time, the FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or "mobile medical apps." • FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in Agency guidances means that something is suggested or recommended, but not required. • Scope • Mobile Platform • Mobile Application (Mobile App) • Mobile Medical Application (Mobile Medical App) • Regulated Medical Device • Mobile Medical App Manufacturer.

FDA 相關指引 • Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance • This guidance document is being distributed for comment purposes only. • Document issued on: June 14, 2013. • Scope • This guidance provides recommendations to consider and document in FDA medical device premarket submissions to provide effective cybersecurity management and to reduce the risk that device functionality is intentionally or unintentionally compromised. For the purposes of this document, cybersecurity is defined as the process of preventing unauthorized modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. • General Principles • Manufacturers should develop a set of security controls to assure medical device cybersecurity to maintain information confidentiality, integrity, and availability. • Security Capabilities • Limit Access to Trusted Users Only • Ensure Trusted Content • Use Fail Safe and Recovery Features • Cybersecurity Documentation.

範例 Resources; http://www.sagentia.com/sectors/medical/patient-care/connected-health.aspx Resources: http://ihealthtran.com/wordpress/2012/10/proposed-fda-office-of-mobile-health/

Q&A

Thank you !!! 陳維斌/ Roger Chen 02-28967790 ext:62486 Roger.Chen@ul.com Contact Information:

陳維斌 , 亞洲區業務協理生命及醫療健康科學事業 Nov, 2013