Health Canada Reporting Requirements

Listing Websites about Health Canada Reporting Requirements

Filter Type:

Incident reporting for medical devices: Guidance document

(1 days ago) Guidance documents are meant to provide assistance on howto comply with governing statutes and regulations. They also serve to provide assistance to staff on how … See more

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

Category:  Medical Show Health

Reporting adverse reactions to marketed health products

(1 days ago) WEBThe success of Health Canada's AR reporting system depends on the quality, completeness, accuracy, and timeliness of the information submitted. For …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/reporting-adverse-reactions-marketed-health-products-guidance-industry/guidance-document.html

Category:  Health Show Health

Preparing and Submitting Summary Reports for Marketed …

(6 days ago) WEBFor natural health products, in addition to complying with regulatory requirements to report safety and efficacy information, Health Canada encourages …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/preparing-submitting-summary-reports-marketed-drugs-natural-health-products-guidance-industry.html

Category:  Health Show Health

Guidance on summary reports and issue-related analyses …

(1 days ago) WEBDevices can also be grouped in a manner that has been specified in jurisdictions outside Canada to meet similar periodic reporting requirements. It’s possible to use the same …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance/summary.html

Category:  Health Show Health

Mandatory reporting requirements for hospitals - Canada.ca

(7 days ago) WEBThe mandatory reporting requirements for hospitals apply to the following therapeutic products: prescription and non-prescription drugs. medical devices. disinfectants. …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting.html

Category:  Medical Show Health

Canada Gazette, Part 2, Volume 154, Number 26: …

(2 days ago) WEBCurrent ISO standard 13485 (Quality Management Systems for Medical Devices), and post-market reporting requirements in the European Union, instruct …

https://gazette.gc.ca/rp-pr/p2/2020/2020-12-23/html/sor-dors262-eng.html

Category:  Medical Show Health

Industry Guide on Mandatory Reporting under the Canada …

(7 days ago) WEBHealth Canada will communicate a decision with you in a written notice within 5 business days from the date on which the request was received by Health Canada. Because the …

https://www.canada.ca/en/health-canada/services/consumer-product-safety/legislation-guidelines/acts-regulations/canada-consumer-product-safety-act/industry/guide-mandatory-reporting-section-14.html

Category:  Health Show Health

Health Canada Adverse Event Reporting for Medical Devices

(9 days ago) WEBHere are the basic steps you should follow in reporting an adverse event in Canada: Reference Canada's Medical Device Regulations, SOR-98-282, and Guidance …

https://www.emergobyul.com/services/health-canada-adverse-event-reporting-medical-devices

Category:  Medical Show Health

Health Canada on Incident Reporting: Timelines and …

(1 days ago) WEBHealth Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to incident reporting under the new regulatory framework, which …

https://www.regdesk.co/health-canada-on-incident-reporting-timelines-and-content/

Category:  Medical Show Health

Guidance Document: Reporting requirements under the

(4 days ago) WEBIt should be noted that there may be additional reporting requirements for health care professionals reporting in provinces and territories that are designated …

https://www.canada.ca/en/health-canada/services/publications/health-system-services/guidance-document-reporting-requirements-under-regulations-amending-regulations-monitoring-medical-assistance-dying.html

Category:  Health Show Health

Mandatory Reporting of Serious ADRs and MDIs ISMP Canada

(8 days ago) WEBThis conceptual model of serious ADR and MDI reporting by hospitals depicts the information provided in the 4 PowerPoint modules: mandatory reporting requirements, …

https://www.ismp-canada.org/mandatory-reporting/

Category:  Health Show Health

Serious adverse drug reactions and medical device incidents - Canada…

(8 days ago) WEBMandatory reporting by hospitals. When a serious adverse drug reaction ( ADR) or medical device incident ( MDI) is documented in a hospital, the hospital must submit a report to Health Canada within 30 calendar days. Health Canada monitors these reports in the interest of public health and patient safety.

https://health-infobase.canada.ca/hospital-adverse-events-dashboard/

Category:  Medical Show Health

Health Canada - Prince Edward Island

(6 days ago) WEB1/16/2020 6 11 MDI Report -Required Data Elements Submitter: • Contact information: The name of the hospital and the contact information of a representative of that hospital …

https://src.healthpei.ca/sites/src.healthpei.ca/files/Quality%20and%20Patient%20Safety/Health_Canada_Mandatory_Reporting_for_Hospitals_Your_Role_in_Patient_Safety.pdf

Category:  Health Show Health

Health Canada Issues New Reporting Requirements for …

(8 days ago) WEBJun 27, 2019. New regulations that apply to hospitals in Canada will require them to report serious adverse drug reactions and medical device incidents to Health Canada within …

https://ohsonline.com/articles/2019/06/27/health-canada-issues-new-reporting-requirements-for-hospitals.aspx

Category:  Medical Show Health

Guidelines for Safety Reporting Requirements to Health …

(6 days ago) WEBFollow-up reports of fatal or life-threatening reactions must include an assessment of the importance and implication of the findings, including relevant previous experience with …

https://wprod.sickkids.ca/siteassets/research/reb/research-ethics-guidelines/sickkids-safety-reporting-requirements-to-health-canada-2020-2021.pdf

Category:  Health Show Health

Canadian regulators issue new reporting requirements for medical …

(9 days ago) WEBDecember 5, 2021. Health Canada, the Canadian medical device market regulator, has published new guidance covering procedures and criteria for medical device …

https://www.emergobyul.com/news/canadian-regulators-issue-new-reporting-requirements-medical-device-shortages

Category:  Medical Show Health

Canada regulations news for medical devices and IVDs

(4 days ago) WEBThe amendments to the Medical Devices Regulations that published in the Canada Gazette, Part II (CGII) in 2020 are: The preparation, retention and submission …

https://www.medtechdive.com/spons/canada-regulations-news-for-medical-devices-and-ivds/611209/

Category:  Medical Show Health

Recent Changes to Medical Device Regulations in Canada

(6 days ago) WEBHealth Canada now requires notification of Summary Report Requirements. Starting December 2021, medical device license holders are required to …

https://www.regdesk.co/summary-recent-changes-to-medical-device-regulations-in-canada/

Category:  Medical Show Health

Guidance on summary reports and issue-related analyses for …

(2 days ago) WEB8 . Guidance on summary reports and issue-related analyses for medical devices To submit a summary report to us: hc.devicelicensing …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-309-2021-eng.pdf

Category:  Medical Show Health

Health Canada Guidance on Incident Reporting RegDesk

(6 days ago) WEBAdditional Incident Reporting Criteria In order to assist medical device manufacturers and other responsible parties in complying with the regulatory …

https://www.regdesk.co/health-canada-incident-reporting/

Category:  Medical Show Health

Guidance Document on Reporting Requirements under the …

(2 days ago) WEBIf you receive a request in one of the provinces or territories listed below, you will submit your report to Health Canada: Yukon Manitoba New Brunswick Nova Scotia Prince …

https://publications.gc.ca/collections/collection_2019/sc-hc/H22-4-14-2019-eng.pdf

Category:  Health Show Health

Health Canada: new PMS requirements for Medical Devices

(1 days ago) WEBFloor 4. Philadelphia, PA 19104. Tel. +1 215-845-9459. [email protected]. On 23 December 2020, new Post-Market Surveillance (PMS) requirements for Medical Devices were published in the Canada Gazette, Part II (CGII), amending the Medical Devices Regulations. New PMS requirements for Medical Devices published …

https://www.thema-med.com/en/2021/01/25/health-canada-new-pms-requirements-medical-devices/

Category:  Medical Show Health

GUIDANCE NOTES FOR REPORTING UNANTICIPATED …

(6 days ago) WEBFHREB requirements for submitting adverse event reports follow Health Canada’s mandatory reporting requirements for serious and unexpected adverse drug reactions and for incidents involving medical devices. GUIDANCE NOTE #1: REGULATORY REQUIREMENTS In Canada, under the Food and Drug Act Regulations Division 5, …

https://www.fraserhealth.ca/-/media/Project/FraserHealth/FraserHealth/Health-Professionals/Research-and-Evaluation-Services/Forms-guidance-notes-and-templates/Forms_guidance_notes_templates_201902/201902_FHGN_Submission_of_Unanticipated_Problems.pdf?rev=1cc3640d5c464473a03af61dc2c12acc

Category:  Food,  Medical Show Health

Clinical Research Regulation For Canada ClinRegs

(5 days ago) WEBHealth Canada. As per the CanadaFDA, the CanadaFDR, the G-CanadaCTApps, and CAN-29, and the CA-ICH-GCPs, the following definitions …

https://clinregs.niaid.nih.gov/country/canada

Category:  Health Show Health

Filter Type: