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

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

醫療器材法規架構Government Regulatory

AuthorityCertification Body

Quality System

Essential PerformanceFunctionAccuracyStability…etc.

Sterilization

BiocompatibilityRadiationSafety

etc.SoftwareValidation

EMCRisk

Management

Electrical Safety

醫療器材管制分類國別 相關法規 / 文件 分級原則 分級 上市審查要求

Taiwan 衛署藥字第8903425號 I

醫療器材優良製造規範, 查驗登記, 臨床相關資料

USA FD&C Act Section 513 一般管制 I 一般管制一般管制, 特別管制 II 一般管制, 特別管制一般管制, 上市前許可 III 一般管制, 上市前許可EU Medical Device 低風險 I Annex 7

Directive Annex IX 中低風險 IIa Annex 2, 3+4, 3+5, 3+6, 7中高風險 IIb Annex 2, 3+4, 3+5, 3+6高風險 III Annex 2, 3+4, 3+5

Canada GD006 / RevDR-MDB 低風險 I中低風險 II GMP中高風險 III 上市前審查, GMP高風險 IV 上市前審查, GMP

Japan 醫藥發字第827號 輕度危害 I 醫療用具GMP中度危害 II 品質系統, 上市前核准(部分免除)嚴重危害 III 品質系統, 上市前核准, 臨床資料(部分免除)威脅生命 IV 品質系統, 上市前核准, 臨床資料

Australia Australian Medical Device 依據個別產品考慮 Registable 上市前審查, GMPRegulation version 4 Listable 廣告與標示管制, 部分GMP

低風險中風險高風險醫療器材優良製造規範(部分免除 )醫療器材優良製造規範, 查驗登記(部分免除 )II

III

第一類第二類第三類常規管理應予以適當管理嚴格管制

醫療器械監督管理條例China 市級政府藥品部審查省, 自治區, 直轄市政府藥品部門審查, 臨床驗證, 品質系統.國務院藥品部門審查, 臨床驗證, 部分產品須安全認證

法規執行單位US EU Japan Canada Australia

Regulatory Body

Food & Drug Administration (FDA)

Competent Authority (CA)

Ministry of Health and Labor Welfare (MHW)

Health Canada (HC)

Therapeutic Goods Administration (TGA)

Pre-Market Reviewer(for product)

FDA+

Accredited Persons

Notified Body (NB)

PMDA or RCB HC TGA

Quality System Auditor

FDA+

Accredited Persons

NB PMDA or RCB Registrar (3rd Party)

CMDCAS

TGA

Post-Market Compliance & Enforcement

FDA NB+ CA PMDA HC TGA

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

60601-1 60601-1-1

60601-2-1

60601-2-2

60601-2-38

60601-1-2 60601-1-460601-1-3

General Standard Collateral Standards

60601-2-50

Particular Standards

Medical Systems

EMC Radiation Protection

Software

Medical Electron Accelerators

High Frequency Surgical Equipment

Electrically Operated Hospital Beds

Infant Phototherapy Equipment

產品電氣安全標準

何為行動醫療 ?

• 透過使用行動設備為病患提供監測與照護的醫療服務 .

• 結合行動科技與醫療照護服務的相關應用 .

• 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/

法規關注範圍

Resources: http://www.mhealthjournal.com/196623/mhealth-summit-ivt-tech-demo/

Government Regulatory AuthorityCertification Body

Quality System

Essential PerformanceFunctionAccuracyStability

…etc.

Sterilization

BiocompatibilityRadiation

Safety

etc.

SoftwareValidation

EMC

Risk Management

Electrical Safety

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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.

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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.

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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.

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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.

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範例

Resources: http://ihealthtran.com/wordpress/2012/10/proposed-fda-office-of-mobile-health/

Resources; http://www.sagentia.com/sectors/medical/patient-care/connected-health.aspx

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Q&A

Thank you !!!

陳維斌 / Roger Chen02-28967790 ext:62486Roger.Chen@ul.com

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