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Notice: Clinical trials for medical devices and drugs
- https://www.canada.ca/en/health-canada/services/clinical-trials/notice-medical-devices-drugs-covid-19-regulations.html
- A flexible pathwayUnder the Regulations, all authorizations and suspensions for clinical trials issu…Records retentionThe Regulations include amendments to the records retention periods t… See more
Guide on applications for COVID-19 medical device …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/covid-19-clinical-trials.html
- It also provides key information for applicants and authorization holders of COVID-19 medical device clinical trials under IO No. 2. A COVID-19 medical device …
Health Canada's Clinical Trials Database - Canada.ca
- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/health-canada-clinical-trials-database.html
- Clinical trials in healthy volunteers. Health Canada authorizes clinical trials involving healthy volunteers, such as bioavailability or bioequivalence trials, first-in-human trials (that is, …
Clinical Trials Modernization: Consultation Paper
- https://www.canada.ca/en/health-canada/programs/consultation-clinical-trials-regulatory-modernization-initiative/document.html
- Health Canada is proposing to modernize the regulation of clinical trials through the establishment of a common risk-based approach for trials involving any type of health …
Medical devices - Canada.ca
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
- The 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 …
Applications for Medical Device Investigational Testing
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance/guidance-document.html
- The manufacturer and the importer of a medical device are required to report to Health Canada incidents that fall under the scope of section 59 of the Regulations within ten (10) days, if the incident has led …
Applications for Medical Device Investigational Testing
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance.html
- 2.3.3.2 Devices used in drug clinical trials (pharmaceuticals and biologics) 2.3.3.3 Combination products and joint reviews. 2.3.4 Organization of an ITA Application. 2.3.5 …
Health Canada Issues Final Guidance on Clinical …
- https://www.emergobyul.com/news/health-canada-issues-final-guidance-clinical-evidence-requirements-medical-devices
- This guidance outlines the general principles and criteria for clinical evidence that may be required for Class III and IV license applications or requested for certain Class II license applications and …
Draft Guidance Document: Applications for Medical …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/consulation-draft-investigational-testing-authorizations-guidance.html
- To provide assistance to manufacturers and importers in preparing the documentation necessary to obtain an authorization for the sale or importation of a medical device under an Investigational Testing …
Open Government Portal - ouvert.canada.ca
- https://ouvert.canada.ca/data/dataset?collection=publication&frequency=as_needed&keywords=medical+devices&res_type=publication&keywords=&keywords=naics+code
- It provides clinically relevant safety information on pharmaceuticals, biologics, medical devices and natural health products. ... The tables below list the COVID-19-related …
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