Health Canada Medical Device Labelling

Listing Websites about Health Canada Medical Device Labelling

Filter Type:

Guidance Document: Guidance for the Labelling of Medical …

(4 days ago) This document provides guidance for the labelling of medical devices, not including in vitro diagnostic devices, such as soft, decorative, contact lenses and menstrual tampons. It includes the … See more

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-labelling-medical-devices-including-vitro-diagnostic-devices-appendices.html

Category:  Medical Show Health

About medical devices - Canada.ca

(2 days ago) WEBTypes of medical devices. Medical devices range from adhesive bandages, toothbrushes and contact lenses to complex devices, such as x-ray units, insulin pumps and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/about-medical-devices.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 on how to complete the application for a new …

(2 days ago) WEBThe device name indicated for a system, medical device family or medical device group family must appear, at least in part, on the label of each member device. Only one name …

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

Category:  Medical Show Health

Guidance Document

(4 days ago) WEBUse the intended use statement and product labelling (e.g. instructions for use/user manual, marketing materials, website) to verify that the software meets the SaMD

https://publications.gc.ca/collections/collection_2020/sc-hc/H164-291-1-2019-eng.pdf

Category:  Health Show Health

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

(6 days ago) WEBMedical Devices Regulations. SOR/98-282. FOOD AND DRUGS ACT. Registration 1998-05-07. Medical Devices Regulations. P.C. 1998-783 1998-05-07. His Excellency the …

https://laws-lois.justice.gc.ca/eng/regulations/SOR%2D98%2D282/FullText.html

Category:  Food,  Medical Show Health

GUIDANCE DOCUMENT

(2 days ago) WEBHow to Complete the Application for a Health Canada New Medical Device Licence Guidance Document 2 Revised Date: 2017/12/29; Effective Date: 2018/03/16

https://publications.gc.ca/collections/collection_2019/sc-hc/H13-9-22-2019-eng.pdf

Category:  Medical Show Health

Guidance for the Interpretation of Significant Change of a Medical …

(Just Now) WEBManufacturers may introduce the modified medical device, or components, for sale in Canada only upon receipt of an amended medical device licence from Health …

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:  Medical Show Health

labl etq dv10-final-eng - canada.ca

(7 days ago) WEBGuidance for the Labelling of Medical Devices Health Canada Guidance Document 2 Date Adopted: 2004/06/12; Effective Date: 2015/07/16 Control Number means a unique …

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/md-im/applic-demande/guide-ld/labl_etq_dv10-final-eng.pdf

Category:  Medical Show Health

List of Recognized Standards for Medical Devices - Canada.ca

(1 days ago) WEBProcessing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/standards/list-recognized-standards-medical-devices-guidance.html

Category:  Medical Show Health

Health Canada drafts guidance on electronic media in labeling

(9 days ago) WEBHealth Canada last week launched a public consultation on its draft guidance for drugmakers on incorporating electronic media, such as websites or mobile …

https://www.raps.org/news-and-articles/news-articles/2021/3/health-canada-drafts-guidance-on-electronic-media

Category:  Health Show Health

Private Label Medical Devices - Canada.ca

(1 days ago) WEBA. Final posting on the Health Canada web site is targeted for June 1, 2005. There will be a six month transition period. Private label manufacturers are expected to have their …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/private-label-medical-devices-questions-answers.html

Category:  Health Show Health

What’s in the FDA Final Rule Regulating Laboratory-Developed …

(2 days ago) WEBLabeling requirements for tests include both the label (including unique device identification to aid in tracking product) and a package insert that describes, among …

https://www.jdsupra.com/legalnews/what-s-in-the-fda-final-rule-regulating-3210849/

Category:  Health Show Health

THAILAND: GUIDELINE FOR EVALUATING DOCUMENTS FOR …

(3 days ago) WEBDevices must have obtained prior approval from recognized reference agencies such as the Australia TGA, Canada HC, European EU NB, Japan MHLW, US …

https://www.qualtechs.com/en-gb/article/thailand-guideline-for-evaluating-documents

Category:  Health Show Health

State Government Sites

(7 days ago) WEBState Government Sites. Alaska Case Law Service. Arizona Court Rules. Arkansas Model Jury Instructions - Civil. Arkansas Regulations. California Code of Regulations. …

https://govt.westlaw.com/nycrr/Browse/Home/NewYork/UnofficialNewYorkCodesRulesandRegulations?contextData=(sc.Default)

Category:  Health Show Health

Filter Type: