Health Canada Releases Guidance for Mandatory Medical Device Problem Reporting

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)

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