Regulatory Open Forum

Hi everyone,

The definition of a recall in Canada is as follows:

A "recall" in respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device:

1. may be hazardous to health
2. may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety
3. may not meet the requirements of the Food and Drugs Act or these regulations

Health Canada also states in GUI-0054: Taking action to fix problems with a device that has been distributed is considered a "correction" and in most cases will meet Health Canada's definition of a recall.

Does this mean ANY correction in the field is reportable to Health Canada?  How does this work for software patch releases or a <g class="gr_ gr_90 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="90" data-gr-id="90">hot fix</g> even when there is NO risk to health and the product is not in violation of the Act? 

FDA's definition of recall is slightly different as it focuses on risk to health and remedying a violation of the Act.  It also talks about reporting exemptions when there is an enhancement, market withdrawal, stock recovery or routine servicing.  Is it possible that a correction to the same 'defective' device could be made in the US and Canada, and be reportable to Health Canada but not to the FDA?  Are there any nuances for software devices in light of patch releases?

Hi everyone,

The definition of a recall in Canada is as follows:

A "recall" in respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device:

1. may be hazardous to health
2. may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety
3. may not meet the requirements of the Food and Drugs Act or these regulations

Health Canada also states in GUI-0054: Taking action to fix problems with a device that has been distributed is considered a "correction" and in most cases will meet Health Canada's definition of a recall.

Does this mean ANY correction in the field is reportable to Health Canada?  How does this work for software patch releases or a <g class="gr_ gr_90 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="90" data-gr-id="90">hot fix</g> even when there is NO risk to health and the product is not in violation of the Act? 

FDA's definition of recall is slightly different as it focuses on risk to health and remedying a violation of the Act.  It also talks about reporting exemptions when there is an enhancement, market withdrawal, stock recovery or routine servicing.  Is it possible that a correction to the same 'defective' device could be made in the US and Canada, and be reportable to Health Canada but not to the FDA?  Are there any nuances for software devices in light of patch releases?