Health Canada Medical Device Program

Listing Websites about Health Canada Medical Device Program

Filter Type:

Health Canada's special access programs: Request access to a …

(5 days ago) Through the special access program (SAP) for medical devices, health care professionals can access custom-made and unlicensed medical devices for patients under their care. To be eligible, they must be entitled under the laws of their provinceto provide health services in that province. These medical … See more

https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/medical-devices.html

Category:  Medical Show Health

Medical devices - Canada.ca

(Just Now) WEBThe term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

Category:  Food,  Medical Show Health

Medical Devices Compliance Program – Health Canada - Canada.ca

(1 days ago) WEBThe Medical Devices Compliance Program (MDCP) of the Regulatory Operations and Enforcement Branch oversees post-market compliance and enforcement, recall …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/medical-devices-program.html

Category:  Medical Show Health

Medical Devices Directorate – Health Canada - Canada.ca

(7 days ago) WEBThe Medical Devices Directorate (MDD) is Canada's regulator of medical devices for human use. Before authorizing the sale of a medical device in Canada, we verify that the device …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/medical-devices-directorate.html

Category:  Medical Show Health

Drug and medical device highlights 2020: Medical …

(9 days ago) WEB2020. 122. Through our Special Access Program, we grant access to health care professionals to medical devices that have not been approved for sale in Canada for emergency use or when alternatives are …

https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2020/medical-devices.html

Category:  Medical Show Health

Health Canada is modernizing and transforming the Medical …

(5 days ago) WEBThe Medical Devices and Compliance Program requires manufacturers and importers to report shortages and discontinuations that could lead to a shortage of …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/modernizing-transforming-medical-devices-program.html

Category:  Medical Show Health

Health product highlights 2021: Medical devices

(4 days ago) WEBIn 2021, we licensed 272 new Class III and 45 new Class IV medical devices. These new devices provide patients and health care professionals with new and innovative options for the treatment, prevention and …

https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-product-highlights-2021/medical-devices.html

Category:  Medical Show Health

Guidance on Medical Device Establishment Licensing (MDEL)

(1 days ago) WEBHealth Canada April 1, 2020 April 1, 2020 Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016) version 7 (April …

https://publications.gc.ca/collections/collection_2020/sc-hc/H14-334-2019-eng.pdf

Category:  Medical Show Health

Guidance Document

(2 days ago) WEBTo provide a transparent outline of the processes Health Canada operates to manage medical device licence applications, in accordance with the Medical Devices …

https://publications.gc.ca/collections/collection_2020/sc-hc/H164-268-2019-eng.pdf

Category:  Medical Show Health

Health Canada and FDA eSTAR Pilot FDA

(2 days ago) WEBUPDATE – January 27, 2023: Health Canada and the FDA launch eSTAR pilot Health Canada and U.S. Food and Drug Administration’s joint eSTAR pilot has reached its …

https://www.fda.gov/medical-devices/how-study-and-market-your-device/health-canada-and-fda-estar-pilot

Category:  Food Show Health

Guidance on clinical evidence requirements for medical devices

(4 days ago) WEBGuidance on clinical evidence requirements for medical devices ii Health Canada is the federal department responsible for helping the people of Canada maintain and improve …

https://publications.gc.ca/collections/collection_2023/sc-hc/H164-347-1-2023-eng.pdf

Category:  Medical Show Health

The Medical Devices Special Access Program in Canada: A Scoping …

(9 days ago) WEBAbstract. New health technologies enter Canadian healthcare organizations in various ways, and understanding them is essential to the development of a pan-Canadian …

https://ncbi.nlm.nih.gov/pmc/articles/PMC5863869/

Category:  Health Show Health

Canada: The Canadian Special Access Program For Medical …

(3 days ago) WEBCanada's Special Access Program allows health care professionals to gain access to Class III or IV custom-made devices and Class II, III or IV medical devices that …

https://www.mondaq.com/canada/healthcare/250970/the-canadian-special-access-program-for-medical-devices

Category:  Medical Show Health

Health Canada launches eSTAR pilot programs to simplify medical …

(6 days ago) WEBRecently, Health Canada announced two pilot programs for eSTAR, an interactive PDF form that guides an applicant through the process of preparing a …

https://www.torys.com/our-latest-thinking/publications/2023/02/health-canada-launches-estar-pilot-programs

Category:  Health Show Health

Health Canada’s Special Access Program for Medical Devices

(8 days ago) WEBThere are many such programs available by several regulatory authorities to help protect patient health. To know more about this program or any other Health …

https://emmainternational.com/health-canadas-special-access-program-for-medical-devices/

Category:  Health Show Health

All courses training-formation

(9 days ago) WEBThe intent of the e-learning course, Understanding How Medical Devices are Regulated in Canada – Medical Device Establishment Licensing and Post-market Regulation, is to …

https://training-formation.phac-aspc.gc.ca/course/index.php?categoryid=42⟨=en

Category:  Medical,  Course Show Health

Update from Health Canada’s Medical Devices Directorate

(3 days ago) WEBMedical Device Program -Organization Bureau of Investigational Testing Authorization, Special Access Program, and Post-Market Surveillance Bureau of • impose or amend …

https://capra.ca/_uploads/654ba1063a1be.pdf

Category:  Medical Show Health

Canada Market Access for Medical Devices BSI America

(1 days ago) WEBThe Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit to meet the QMS/GMP requirements of multiple Regulatory Authorities …

https://www.bsigroup.com/en-US/medical-devices/Global-market-access/Canadian-market-access/

Category:  Medical Show Health

HEALTH CANADA - Livingston International

(7 days ago) WEBPGA: Health Canada Program: Medical Devices Implementation of the CBSA Single Window Initiative (SWI) The CBSA assists Health Canada in administering the following …

https://www.livingstonintl.com/livingston-content/uploads/2018/11/Program-sheet_HC_Medical-Devices-ENv2.pdf

Category:  Medical Show Health

9 Ways Canadian Medical Device Regulations Differ From the US

(3 days ago) WEBIn the Canadian regulatory framework, one exciting current change is regarding the Medical Device Single Audit Program (MDSAP). Health Canada was …

https://www.qualio.com/blog/canadian-medical-device-regulations

Category:  Medical Show Health

MDSAP Compliance in Canada Emergo by UL

(4 days ago) WEBAn Emergo quality system complies not only with ISO 13485, but additional medical device regulatory requirements in many other markets. In addition to ISO 13485 consulting, we …

https://www.emergobyul.com/services/mdsap-and-health-canada-iso-13485-qms-compliance

Category:  Medical Show Health

MDSAP Medical Device Single Audit Program Device License

(9 days ago) WEBAnyone looking to manufacture a Class II, III or IV medical device in Canada requires a Medical Device Licence (MDL) for each product they sell. In order to obtain …

https://qualitysmartsolutions.com/blog/mdsap-what-is-it-and-how-does-it-apply-to-my-medical-device/

Category:  Medical Show Health

Health Canada Regulatory Consulting services - mdi Consultants

(2 days ago) WEBIn accordance with Health Canada regulations, all manufacturers of class II, III and IV medical devices must have compliance with the MDSAP (Medical Device …

https://mdiconsultants.com/health-canada-regulatory-consulting-services/

Category:  Medical Show Health

CADTH Is Now Canada’s Drug Agency CDA-AMC

(5 days ago) WEBIn December 2023, it was announced that Canada’s Drug Agency would be built from CADTH. The work of the drug agency expands on CADTH’s existing mandate …

https://www.cadth.ca/news/cadth-now-canadas-drug-agency

Category:  Health Show Health

1 million seniors can now access services under the - canada.ca

(4 days ago) WEBStarting today, the first one million seniors who successfully applied to the Canadian Dental Care Plan (CDCP) and have a May coverage start date in their …

https://www.canada.ca/en/health-canada/news/2024/05/1-million-seniors-can-now-access-services-under-the-canadian-dental-care-plan.html

Category:  Health Show Health

Apple Watch Heart Health Feature Wins First Of Its Kind Approval

(1 days ago) WEBThe Apple Watch’s AFib History feature makes it the first digital health device cleared for an FDA program that qualifies devices for clinical studies.

https://www.forbes.com/sites/davidphelan/2024/05/03/apple-watch-key-health-feature-wins-1st-of-a-kind-approval/

Category:  Health Show Health

Wegovy set to launch in Canada. What to know about the weight …

(1 days ago) WEBHealth Canada approved Wegovy in November 2021 based on studies that “demonstrated a statistically significantly greater amount of weight loss in semaglutide …

https://globalnews.ca/news/10464627/wegovy-canada-launch-what-tok-know/

Category:  Health Show Health

Canada's dental care plan begins today. Here's what you need to …

(3 days ago) WEBCanada’s national dental care plan begins covering 1.9 million seniors today — the first phase of a massive public oral health-care insurance program that …

https://www.cbc.ca/news/politics/canadian-dental-care-plan-cdcp-seniors-coverage-begins-may-1-1.7189717

Category:  Health Show Health

Green upgrades coming to the Michipicoten First Nation Health …

(3 days ago) WEBMichipicoten First Nation, May 1, 2024 — Retrofits and an expansion are coming to the Michipicoten First Nation Health Centre. The federal government is …

https://www.canada.ca/en/office-infrastructure/news/2024/04/green-upgrades-coming-to-the-michipicoten-first-nation-health-centre.html

Category:  Health Show Health

Canada to introduce new rules around off-campus work hours for

(1 days ago) WEBApril 29, 2024—Ottawa—International students enrich Canada’s social, cultural and economic fabric.That is why, in recent months, Immigration, Refugees and …

https://www.canada.ca/en/immigration-refugees-citizenship/news/2024/04/canada-to-introduce-new-rules-around-off-campus-work-hours-for-international-students.html

Category:  Health Show Health

What consumers should know as Philips agrees to $1.1 billion …

(1 days ago) WEBThe medical device maker Philips has agreed to a $1.1 billion settlement to address claims brought by thousands of people with sleep apnea who say they were …

https://www.npr.org/2024/04/29/1247774390/cpap-philips-sleep-apnea-injury-lawsuit

Category:  Medical Show Health

Changes to the Start-up Visa and Self-Employed Persons …

(2 days ago) WEBImmigrants account for about one third of business owners with paid staff in Canada.. Canada ranked number one as the most attractive destination for start-up …

https://www.canada.ca/en/immigration-refugees-citizenship/news/2024/04/changes-to-the-start-up-visa-and-self-employed-persons-programs-to-help-reduce-backlogs-and-improve-processing-times.html

Category:  Health Show Health

Black youth face multiple barriers accessing mental health care

(9 days ago) WEB2:10 CMAJ publishes first edition of anti-black racism series Black youth in Canada face multiple barriers in getting access to mental health services — and health …

https://globalnews.ca/news/10469585/black-youth-barriers-to-mental-health-care/

Category:  Health Show Health

Filter Type: