Health Canada Medical Device Review Timelines

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Management of Applications for Medical Device Licences

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-licences-investigational-authorizations.html

2.14.3 Impact on Review Process; View complete guide. Download PDF (287 KB, 22 pages) Details and history. Published: 2001-03-27 Date Posted: 2019/11/08 Effective Date: 2020/04/01 Part of topic(s): Guidance on legislation. For assistance Contact Us: Application and Invoice Inquiries Medical Device … See more

Guidance Document: Management of Applications for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-guidance-2019/document.html

A Class III, IV application is considered grossly deficient when there is an omission of review components (as applicable) in the application as listed and described …

Service Standards for Medical Device Submission …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/service-standards-high-volume-regulatory-authorizations/service-standards-medical-device-submission-evaluations-under-medical-device-regulations.html

The evaluation of medical device submissions is a service with a high volume of regulatory transactions used by industry and health care professionals for all medical devices …

Frequently asked questions: Medical device …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/annual-review-documents/frequently-asked-questions-medical-device-establishment-licensing-fees.html

What is a medical device? The term 'medical device' covers a wide-range of …

What MDEL holders need to know about annual licence …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2022.html

To continue doing business, holders of an active medical device establishment licence (MDEL) must apply to have their licence reviewed every year …

Guidance Document: The Management of …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html

The Medical Devices Directorate (MDD) is responsible for reviewing scientific information to assess the safety, effectiveness and quality of medical …

Drug and medical device highlights 2020: Medical …

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

We review applications to allow companies to conduct investigational testing (clinical trials) on medical devices in Canada. New trials mean Canadians may have access to more …

Aligned reviews between Health Canada …

https://www.canada.ca/en/health-canada/corporate/transparency/regulatory-transparency-and-openness/improving-review-drugs-devices/notice-aligned-reviews-health-canada-health-technology-assessment-organizations.html

Health Canada's Regulatory Review of Drugs and Devices initiative aims to provide more timely access to drugs and devices. We are therefore giving the option to sponsors to …

THE DRUG REVIEW AND APPROVAL …

https://spharm-inc.com/the-drug-review-and-approval-process-in-canada-an-eguide/

It can take anywhere from 6 months to 2 years for Health Canada to review drug safety and efficacy information before providing a decision on whether an NOC is to be granted. …

Health Canada Screening and Review Timelines

https://connect.raps.org/discussion/health-canada-screening-and-review-timelines

Health Canada Screening and Review Timelines | Regulatory Open Forum Regulatory Open Forum Community Home Discussion 48.9K Library Members View Only Related …

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