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Regulations to allow exceptional importation of medical devices to address shortages as of March 2, 2022 Medical Devices Compliance Program Bulletin, February 16, 2022 Amendments to the Medical Devices Regulations (MDR), published in Canada Gazette, Part II in September 2021,…
Guidance on new regulations for exceptional importation and sale of foreign-authorized drugs in Canada to mitigate drug shortages Drug Establishment Licensing Bulletin 129, February 22, 2022 On this page New guidance Background What this means for DEL holders Contact us New…
Notice of updated guidance: Applications for COVID-19 medical device clinical trials under the Regulations The Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (the Regulations) were published on March 2, 2022, and came into effect on February 27,…
Avis aux intervenants - Énoncé de politique sur l’attribution de noms aux médicaments biologiques Santé Canada remercie tous ceux et celles qui ont répondu à la consultation de 2018 sur l’attribution de noms aux médicaments biologiques. Un rapport « Ce que nous avons entendu »…
Cells, Tissues, and Organs for Transplantation and Assisted Human Reproduction Guidance on the Safety of Human Cells, Tissues and Organs for Transplantation Regulations [2025-03-12] Notice - DRAFT 2 nd Edition " Guidance Document for Cell, Tissue and Organ Establishments: Safety…
ARCHIVED - Executive Summary: Look-Alike Sound-Alike (LA/SA) Health Product Names Consultative Workshop We have archived this page and will not be updating it. You can use it for research or reference. We have archived this page and will not be updating it. You can use it for…
ARCHIVED - Issue Analysis Summary: Look-alike Sound-alike (LA/SA) Health Product Names: The Development of a Comprehensive Policy Recommendation for Look-alike Sound-alike (LA/SA) Health Product Names We have archived this page and will not be updating it. You can use it for…
Look-alike Sound-alike (LA/SA) Health Product Names Comments and Responses to the Related Guidances. Date 2005-08-03 (PDF Version - 75 K) Contact Policy and Promotion Division Biologics and Genetic Therapies Directorate 2nd Floor, Building # 7 Address Locator # 0702E Tunney's…
ARCHIVED - Look-alike Sound-alike Health Product Names: Comments and Responses to the Issue as Presented in the Issue Analysis Summary We have archived this page and will not be updating it. You can use it for research or reference. We have archived this page and will not be…
Templates - Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies In order to help expedite the review process, manufacturers or sponsors are expected to summarize drug submission data related to quality, or safety and efficacy, using the following…
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