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3D printing and other manufacturing of personal protective equipment in response to COVID-19 Find information on the requirements for getting medical devices authorized in Canada on the medical devices page. Background During the COVID-19 pandemic, the demand for certain medical…

Using a blood glucose meter and test strips On this page Blood glucose meters and test strips Tips for accurate test results Causes of inaccurate readings Blood glucose meters and test strips You can manage your diabetes successfully by testing your blood glucose (sugar) level at…

Vaginal surgical mesh: Overview Overview Risks What you should know Health Canada's role Evidence and safety reviews Report a problem or concern Subscribe to get vaginal surgical mesh updates On this page About vaginal surgical mesh Vaginal surgical mesh in pelvic procedures…

About medical devices Health Canada encourages and invites stakeholders to utilize and benefit from the Device Advice e-learning tool How medical devices are licensed and monitored in Canada. On this page What are medical devices How medical devices are licensed and regulated…

Medical Devices Action Plan – stakeholder meetings and engagement activities A Progress report for Medical Devices Action Plan was published in May 2021. The federal government is committed to providing Canadians with more opportunities to learn about and participate in…

Projects Summary Basis of Decision (SBD) Date: 2004-11-05 Registration and Disclosure of Clinical Trial Information Page details 2017-05-04

Standards The following are links to the list of national and international medical device standards recognized by the Medical Device Directorate (MDD) and related information. Unless otherwise indicated, the complete standard, including appendices and attachments, is recognized.…

Quality Systems ISO 13485 Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued…

Licences Establishment Licence Listings Medical Devices Licence Listings Medical Devices Active Licence Listing (MDALL) Purchase of Licensed Medical Devices for Use in Health Care Date: 2001-01-15 Page details 2017-05-04

Legislation and Guidelines - Medical devices Acts and Regulations The Therapeutic Products Directorate (TPD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to ensure that the pharmaceutical drugs and medical…