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

Harmonized Site Licence and FSRN Application Form - Canada.ca

(1 days ago) WEBSite Licence. Choose this option if you are applying to begin activities with respect to natural health products (NHPs), or if you already hold a valid site licence that you intend …

https://nnhpd-site-licence-dexploitation-dpsnso.hc-sc.gc.ca/websla/en/application

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

Natural health product licence amendment and notification form …

(6 days ago) WEBNatural health product licence amendment and notification form user guide / published by the authorisation of the Minister of Health ; Health Products and Food Branch. : H164 …

https://publications.gc.ca/site/eng/9.853449/publication.html?wbdisable=true

Category:  Food 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

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

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

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

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

GUIDANCE DOCUMENT Guidance on supporting evidence to …

(3 days ago) WEBTo facilitate the submission to Health Canada of scientific and clinical content for medical device licence applications and licence amendment applications for Class III and …

https://www.fdanews.com/ext/resources/files/archives/0/08/08-12-Canada_guidance.pdf

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

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 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 on Significant Changes: Guidance for Implementation

(8 days ago) WEBAug 4, 2021. Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to …

https://www.regdesk.co/health-canada-on-significant-changes-guidance-for-implementation/

Category:  Health 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

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 for the Interpretation of Significant Change of a

(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

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

Fees for Health Canada - Canada.ca

(9 days ago) WEBAnnual fee - Licence for micro-cultivation. (a) If the cannabis revenue is $1 million or less, the greater of 1% of the cannabis revenue, and $2,500; or. (b) if the cannabis revenue is …

https://www.canada.ca/en/health-canada/services/funding/fees-health-canada.html

Category:  Health Show Health

Consultation round for GUI-0046 - Canada.ca

(1 days ago) WEBDrug Establishment Licensing Bulletin 142, September 10, 2024. On this page. How to participate; About the consultation. Health Canada has released Annex …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/notice-consultation-round-gui-0046.html

Category:  Health Show Health

Filter Type: