The obligation of Medical Device Manufacturers doesn’t stop after obtaining clearance and approvals from competent health authorities but they are required to report adverse events to those authorities wherever applicable.

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Implementing Global Adverse Event Reporting Systems
in EU, Canada and US
Presenter
Dr. David Lim
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The purpose of this session is to get you acquainted with adverse event reporting
requirements and systems in EU, Canada and US.

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Disclaimer
• do not represent and should not be
construed to represent the host or policy.
• are my own views, interpretation and
understanding of the relevant and
applicable information (laws, regulations,
standards, rules and/or guidances).
• may be most helpful and effective when
used in conjunction with your professional
judgment and discretion.
• are not all inclusive.
The
contents
of this
presenta
tion:

3. Copyright © 2014 REGULATORY DOCTOR. All Rights Reserved. 3
Objectives
 Applicable and relevant laws and regulations in EU, Canada and US
 Definitions
 Medical device adverse event reporting requirements in EU, Canada and US
 Medical device vigilance system during the post-production phase in EU
 Mandatory medical device problem reporting requirements in Canada
 Mandatory medical device reporting requirements in US
 Review of actual reporting forms in EU, Canada and US
 Applicable and relevant guidance documents
 Common mistakes and how to prevent them
 Best practices
 PASS-IT solutions
 Conclusion

4. Copyright © 2014 REGULATORY DOCTOR. All Rights Reserved. 4
To see the complete presentation check the
below link:
http://www.audioeducator.com/pharma-biotech/implement-global-adverse-
event-reporting.html