Health Canada License Amendment

Listing Websites about Health Canada License Amendment

Filter Type:

Medical Devices Licence Amendment Minor Change Form Canada

(6 days ago) WEB2004 Health Canada form to facilitate the approval of device licence amendments where the change involved consists of a change to the manufacturer's name or address on an existing device licence(s)

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/medical-devices-licence-amendment-back-form-guidance-manufacturer.html

Category:  Health Show Health

Class II medical device licence amendment application form

(8 days ago) WEBHealth Canada pub.: 220285 Protected B when completed Class II medical device licence amendment application form (disponible en français) 1. Name of device licence being …

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/md-im/applic-demande/form/md_licam_im_demmhom_cla2-eng.pdf

Category:  Medical Show Health

Natural health product licence amendment and notification form

(7 days ago) WEBNote that this form applies only to amendments and notifications as described in Part 1 Section 11 and 12 of the Natural Health Products Regulations (NHPR). For information …

https://nnhpd-anf-fmn-dpsnso.hc-sc.gc.ca/nnhpd-forms/landing_atterrissage.htm

Category:  Health Show Health

Guidance on how to complete the application for a new …

(2 days ago) WEBIf additional space is required, photocopy the Item 12 page and attach it to the application form. For a single device: Enter the name of the device in the first column. Enter the …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-315-2021-eng.pdf

Category:  Health Show Health

Guidance on how to complete the application for a new medical …

(5 days ago) WEBCanada. Health Canada, issuing body. Title : Guidance on how to complete the application for a new medical device licence. Publication type : Monograph : Language [English] …

https://www.publications.gc.ca/site/eng/9.897605/publication.html

Category:  Medical Show Health

Health Canada Notice on Interpretation of Significant …

(5 days ago) WEBAt the same time, the requirement related to applying for an amendment medical device license applies only for Class III and IV medical devices. As stated by Health Canada, the document provides a …

https://www.regdesk.co/health-canada-notice-on-interpretation-of-significant-changes/

Category:  Medical Show Health

Update from Health Canada’s Medical Devices Directorate

(3 days ago) WEBAfter 3 years of responding to the pandemic, Health Canada’s Medical Devices Directorate is re-normalizing performance against service standards and is undertaking new …

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

Category:  Medical Show Health

Draft Class II Medical Device Licence Amendment Application …

(5 days ago) WEBApplication forms should be sent to: Device Licensing Services Division Medical Devices Bureau Therapeutic Products Directorate Health Canada 2934 Baseline Road Address …

https://www.fdanews.com/ext/resources/files/10-14/10-04-14-HC-Guidance.pdf?1413990018

Category:  Medical Show Health

Guidance on clinical evidence requirements for medical devices

(4 days ago) WEBA comparator device should be licensed in Canada. If not, please provide objective evidence of safety and effectiveness to Health Canada, along with a side-by-side …

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

Category:  Health Show Health

Medical Devices Licence Amendment Fax-back Form Canada

(8 days ago) WEB2010 Health Canada form to facilitate the approval of device licence amendments where the change involved consists of the addition/deletion of new catalogue/model numbers …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/medical-devices-licence-amendment-form-guidance.html

Category:  Health Show Health

Health Canada Guidance for Private Label Medical Devices

(Just Now) WEBApr 16, 2020. The Health Canada, the Canadian authority responsible for medical devices regulation, issued guidance dedicated to the application for a new license of making …

https://www.regdesk.co/health-canada-guidance-for-private-label-medical-devices/

Category:  Medical Show Health

License Amendment Triggers in Canada rqmplus.com

(8 days ago) WEBWe were concerned specifically how this affected the current license in Canada. I read the Health Canada Guidance for Interpretation of Significant Change of …

https://www.rqmplus.com/blog/2013/10/product-re-registration-canada/

Category:  Health Show Health

Medical Devices Regulations ( SOR /98-282) Site Web de la

(Just Now) WEB35 (1) If the information and documents submitted in respect of an application for a medical device licence or a medical device licence amendment are insufficient to enable the …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-3.html

Category:  Medical Show Health

Does a "Significant Change" apply to Class II Medical Devices?

(2 days ago) WEBIf so, then a Licence Amendment Fax-back form for non-significant additions of catalogue numbers can be filled and sent to Health Canada. This is …

https://elsmar.com/elsmarqualityforum/threads/does-a-significant-change-apply-to-class-ii-medical-devices.52937/

Category:  Health Show Health

Medical device application and report forms Canada.ca

(Just Now) WEBApplication forms listed below must accompany medical device applications filed by a manufacturer or sponsor. Medical Device Licence Application Fee Form [2024 …

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

Category:  Medical Show Health

Medical Devices Regulations ( SOR /98-282) Site Web de la

(9 days ago) WEB43.1 - Obligation to Submit Certificate. 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing. 43.2 - Medical Devices to Be Sold for the …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

Category:  Medical Show Health

Guidance Document publications.gc.ca

(2 days ago) WEBThis document outlines the way in which Health Canada manages applications for medical device licences. 1.2 Scope and Application This guidance document applies to the …

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

Category:  Medical Show Health

Canada Gazette, Part 1, Volume 156, Number 51:

(1 days ago) WEBThe amendments would enhance Health Canada’s capacity for continued oversight, assessment, and communication at both the licensing stage and once …

https://canadagazette.gc.ca/rp-pr/p1/2022/2022-12-17/html/reg1-eng.html

Category:  Health Show Health

Management of Applications for Medical Device Licences

(2 days ago) WEBApplication and Invoice Inquiries. Medical Device Directorate, Device Licensing Services Division. Health Canada. 11 Holland Avenue. Address Locator 3002A. Ottawa, Ontario …

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

Category:  Medical Show Health

Canadian amendments introduce expanded medical device post …

(7 days ago) WEBHealth Canada (HC) published SOR/2020-262 in the Canada Gazette, consisting of significant amendments to the Food and Drug Regulations and the …

https://www.emergobyul.com/news/canadian-regulatory-amendments-introduce-expanded-post-market-surveillance-provisions

Category:  Food Show Health

Guidance for the Interpretation of Significant Change of a Canada

(Just Now) WEBA manufacturer is required to submit a licence amendment to Health Canada for review and authorization once they have determined that the proposed …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-interpretation-significant-change-medical-device.html

Category:  Health Show Health

Filter Type: