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Health Canada invites public comments on new post-market reporting regulations
  • Gowling WLG
  • USA, Canada
  • August 9 2018

The medical device industry in America and perceived shortcomings in the US Food and Drug Administration's ("FDA") approval process have recently come


3D-printed food when will the laws take shape?
  • Gowling WLG
  • USA, Canada
  • September 12 2016

3D printing is the new buzz technology being used to replicate human tissues, fighter jet parts, and human prosthetics. The technology is also


Update on Vanessa’s Law: The implementation of Health Canada’s powers under the modernized Food and Drugs Act
  • Gowling WLG
  • Canada
  • July 6 2016

In my earlier article Bill C-17: modernizing the Food and Drugs Act but at what cost?, I described the potential implications of the Protecting


La cybersécurité et les dispositifs médicaux : les données médicales électroniques augmentent le risque de litige en responsabilité du fait du produit pour les fabricants d’appareils médicaux
  • Gowling WLG
  • Canada
  • May 3 2016

La valeur des renseignements médicaux personnels volés est de dix à vingt fois plus importante qu’un numéro de carte de crédit volé1. Alors que


Cybersecurity and medical devices: Electronic medical data increases product liability risk for medical device manufacturers
  • Gowling WLG
  • USA, Canada
  • May 3 2016

The value of stolen personal health information is ten to twenty times greater than a stolen credit card number.1 As the health-care industry


Coming soon to Canadian medical device manufacturers? "Failure to train" cases south of the border
  • Gowling WLG
  • USA, Canada
  • October 21 2014

Medical device manufacturers (“MDMs”) often have to defend against novel theories of liability put forward by plaintiff counsel. The most recent


A medical device has its day in court Andersen v. St. Jude Medical
  • Gowling WLG
  • Canada
  • July 11 2012

On June 26, 2012, the Ontario Superior Court released its much-anticipated decision in Andersen et al. v. St. Jude Medical, Inc. et al.


Security, sabotage and privacy: legal concerns for medical device makers
  • Gowling WLG
  • Canada
  • June 28 2011

Implantable medical devices (IMDs), including pacemakers, neurotransmitters and drug pumps, use embedded computer technology and radios to monitor and treat certain chronic diseases.


Regulatory reform for therapeutic products: drugs, devices and natural health products
  • Gowling WLG
  • Canada
  • June 28 2011

Another year has passed, and still legislation amending the Food and Drugs Act (Act) has not been reintroduced.


Two amendments to pharma legislation come into force
  • Gowling WLG
  • Canada
  • April 14 2011

The Amendments to The Food and Drug Regulations (1319- New Drugs For Extraordinary Use) came into force on March 25, 2011.