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CE Marking , FDA Approval and Associated Regulations for Wellness

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Inner Ear
Inner Ear

This document discusses key regulatory considerations for medical device approval in major markets. It provides an overview of regulatory strategies and approval processes in the US, EU, Canada and other countries. Major topics covered include device classification systems, premarket approval requirements, quality management standards, clinical data requirements and post-market obligations. Common mistakes made by companies and the importance of developing a comprehensive regulatory strategy early on are also addressed.

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Overview ,[object Object],[object Object]
Questions you may have!! ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Questions you may have!! ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Similarities/Differences Global Regulatory Approaches 5 Go to Regulatory Body Class (Risk Based) Market Approval Quality System Adverse Event Reporting United States (U.S.) FDA Center for Devices and Radiological Health Class 1, 2, 3 Exempt Clearance Approval letter QS Regulations 21 CFR 820 MDR Canada Health Canada Class I, II, III, IV MD License except Class I CAN/CSA ISO 13485 Vigilance System EU (European Union) Competent Authority Notified Body Class I, IIa, IIb, III CE Marking MDD/IVDD EN ISO 13485 Vigilance System Japan Ministry of Health, Labour and Welfare Class 1, 2, 3, 4 MHLW Approval certificate QMS Ordinance ISO 13485 Vigilance System Australia Therapeutic Goods Administration Similar to EU. Similar to EU ISO 13485 Vigilance System
Background Information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CONFIDENTIAL Page 6
Background Information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CONFIDENTIAL Page 7
US vs. the E.U. and Canada ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CONFIDENTIAL Page 8
US vs. the E.U. and Canada ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CONFIDENTIAL Page 9
US vs. the E.U. and Canada ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CONFIDENTIAL Page 10
Key Differences ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CONFIDENTIAL Page 11
Other Things To Remember ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CONFIDENTIAL Page 12
With so many regulations out there…… where do you start?
Regulatory Strategy Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CONFIDENTIAL Page 14
Regulatory Strategy Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CONFIDENTIAL Page 15
Regulatory Strategy Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CONFIDENTIAL Page 16
Common Mistakes / Misconceptions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CONFIDENTIAL Page 17
Outsourced design and mfg ,[object Object],© 2005 Emergo Group, Inc. Australia > Canada > The Netherlands > United States 1.800.956.6588
Software ,[object Object],[object Object],© 2005 Emergo Group, Inc. Australia > Canada > The Netherlands > United States 1.800.956.6588
EU Device Regulations - WEEE ,[object Object],[object Object],[object Object],© 2005 Emergo Group, Inc. Australia > Canada > The Netherlands > United States 1.800.956.6588
Consider Regulatory Issues Early On ,[object Object],[object Object],[object Object],[object Object]
Reminders to take home..... ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Medical Device Myth’s ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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[object Object],[object Object],www.wellnesshealthinnovation.orgICS Confidential

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CE Marking , FDA Approval and Associated Regulations for Wellness

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  • 6. Similarities/Differences Global Regulatory Approaches 5 Go to Regulatory Body Class (Risk Based) Market Approval Quality System Adverse Event Reporting United States (U.S.) FDA Center for Devices and Radiological Health Class 1, 2, 3 Exempt Clearance Approval letter QS Regulations 21 CFR 820 MDR Canada Health Canada Class I, II, III, IV MD License except Class I CAN/CSA ISO 13485 Vigilance System EU (European Union) Competent Authority Notified Body Class I, IIa, IIb, III CE Marking MDD/IVDD EN ISO 13485 Vigilance System Japan Ministry of Health, Labour and Welfare Class 1, 2, 3, 4 MHLW Approval certificate QMS Ordinance ISO 13485 Vigilance System Australia Therapeutic Goods Administration Similar to EU. Similar to EU ISO 13485 Vigilance System
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  • 14. With so many regulations out there…… where do you start?
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