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Posted 30 December 2011 | By Alexander Gaffney, RAC
Health Canada (HC) released a new guidance document on Thursday that clarifies the Medical Devices Regulations' mandatory problem reporting for medical devices.
The guidance document aims to conform to the harmonized approach set forth by the Global Harmonization task force in N54 - Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices.
HC also released an updated medical device problem reporting form along with the guidance.
(Health Canada - MPR Guidance for Industry)
(Health Canada - MPR Reporting Form)
Tags: Mandatory Problem Reporting, Guidance for Industry, Latest News, guidance, medical device
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This article provides a variety of websites with important information on recent changes to FDA guidances and tables ...