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Medical Device Advice, Inc.

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LINKS TO HEALTH CANADA NEWS, ALERTS & RESOURCES

Drug & vaccine authorizations for COVID-19

COVID-19 Medical Device Establishment Licence suspensions

Update on AstraZeneca, COVISHIELD COVID-19 vaccines

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Update on AstraZeneca, COVISHIELD COVID-19 vaccines

COVID-19 Medical Device Establishment Licence suspensions

Update on AstraZeneca, COVISHIELD COVID-19 vaccines

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COVID-19 Medical Device Establishment Licence suspensions

COVID-19 Medical Device Establishment Licence suspensions

Technical requirements for anti-microbial claims for medical masks

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Technical requirements for anti-microbial claims for medical masks

Technical requirements for anti-microbial claims for medical masks

Technical requirements for anti-microbial claims for medical masks

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Notice to manufacturers, importers & distributors

Technical requirements for anti-microbial claims for medical masks

Importation and sale of Medical Devices for COVID-19

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Importation and sale of Medical Devices for COVID-19

Technical requirements for anti-microbial claims for medical masks

Importation and sale of Medical Devices for COVID-19

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Health Canada will be updating its safety review of breast implants

Health Canada will be updating its safety review of breast implants

Health Canada will be updating its safety review of breast implants

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Health Canada encourages Canadians to report ........

Health Canada will be updating its safety review of breast implants

Health Canada will be updating its safety review of breast implants

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LIFEPAK 15 Monitor/Defibrillator Recall

Health Canada will be updating its safety review of breast implants

LIFEPAK 15 Monitor/Defibrillator Recall

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T2 Femur Instrument Tray Recall

Bio-Medic Synthetic Medical Gloves Recall

LIFEPAK 15 Monitor/Defibrillator Recall

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neoBLUE blanket LED Phototherapy Recall

Bio-Medic Synthetic Medical Gloves Recall

Bio-Medic Synthetic Medical Gloves Recall

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Bio-Medic Synthetic Medical Gloves Recall

Bio-Medic Synthetic Medical Gloves Recall

Bio-Medic Synthetic Medical Gloves Recall

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Health Canada to confirm its priority review

Health Canada Fees for Medical Devices

Health Canada Fees for Medical Devices

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Health Canada Fees for Medical Devices

Health Canada Fees for Medical Devices

Health Canada Fees for Medical Devices

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Medical Device Application Information

Health Canada Fees for Medical Devices

Medical Device Application Information

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Medical Devices - Guidance Documents

Link between Fibristal and risk of liver injury

Medical Device Application Information

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Nokia Blood Pressure Monitor Recall

Link between Fibristal and risk of liver injury

Link between Fibristal and risk of liver injury

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Link between Fibristal and risk of liver injury

Link between Fibristal and risk of liver injury

Link between Fibristal and risk of liver injury

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Recall of Cannabis for Medical Purposes

Health Canada Warning of an Alcohol Substitute

Recall of Cannabis for Medical Purposes

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DUREX RealFeel 20 ct condoms Recall

Health Canada Warning of an Alcohol Substitute

Recall of Cannabis for Medical Purposes

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Health Canada Warning of an Alcohol Substitute

Health Canada Warning of an Alcohol Substitute

Health Canada Warning of an Alcohol Substitute

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Menstrual Tampons Recall

Plasma Pens May Pose Health Risks

Health Canada Warning of an Alcohol Substitute

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Plasma Pens May Pose Health Risks

Plasma Pens May Pose Health Risks

Plasma Pens May Pose Health Risks

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Transition to the MDSAP

Plasma Pens May Pose Health Risks

Plasma Pens May Pose Health Risks

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Health Canada Drug and Medical Device Databases

Inside Health Canada's Medical Device Records (Courtesy of CBC)

Inside Health Canada's Medical Device Records (Courtesy of CBC)

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Inside Health Canada's Medical Device Records (Courtesy of CBC)

Inside Health Canada's Medical Device Records (Courtesy of CBC)

Inside Health Canada's Medical Device Records (Courtesy of CBC)

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Pre-market Requirements for MD Cybersecurity

Inside Health Canada's Medical Device Records (Courtesy of CBC)

Pre-market Requirements for MD Cybersecurity

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How were COVID-19 vaccines developed so quickly?

COVID-19 vaccines were developed quickly without skipping any safety steps thanks to advances in science, international collaboration and increased funding.

How do I know COVID-19 vaccines are safe?

Only vaccines that are safe effective and of the highest quality are authorized by Health Canada. Canada is recognized around the world for its high standards and rigorous vaccine review process.

DO COVID-19 VACCINES HAVE SIDE EFFECTS?

You may feel some mild side effects. It's a sign that your body is building protection and they should resolve within a few days on their own. Severe reactions to a vaccine are very rare.

How do COVID-19 mRNA vaccines work?

The COVID-19 mRNA vaccines provide instructions for how to make a protein that will trigger an immune response. Your body then prepares antibodies and cells that help you fight the virus if it enters your body in the future.

How do I know covid-19 vaccines are safe?

Clinical trials for COVID-19 vaccines have been taking place since the spring of 2020 and millions of people around the world have already been vaccinated.

Canada Consumer Product Safety Act and Food and Drugs Act

Health Canada inspectors from the Consumer Product Safety Program (CPSP) enforce the Canada Consumer Product Safety Act and its associated regulations, as well as the Food and Drugs Act, Cosmetic Regulations.

Mandatory Reporting

The Canada Consumer Product Safety Act, reporting requirement under Section 14, clearly defines industry's obligations, helps consumers to make informed choices about the products they purchase, and provides government with the tools to take action when necessary. 


Drug and medical device post market surveillance

Health Canada closely monitors and responds to emerging ‘signals’ about the drugs and medical devices Canadians are using.


They order changes to drug labels, add new warnings, or advise when certain drugs should not be taken together.

Health Canada aims to improve safety of medical devices

Health Canada announced new measures to improve the safety, effectiveness and quality of medical devices. This comes after an investigation by CBC News and an international consortium of journalists.


This video is courtesy of CBC News : The National.

Clinical trials and special access

Drugs and medical devices that are not approved may also be available through our Special Access Programs.


The Special Access Program for medical devices provides access to custom-made or unlicensed devices.


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