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- 16:28, 14 December 2021 diff hist +7 HCmeddev Uploaded V2 of the information session deck Tag: Visual edit
- 16:08, 14 December 2021 diff hist 0 N File:Information session- Regulations amending the Medical Devices Regulations (February 2021) - V2.pdf current
- 15:47, 13 August 2021 diff hist -6 m SCinstrmed Edited email address (removed "hc" and "sc" from beginning and end to reflect the correct address) Tag: Visual edit
- 15:46, 13 August 2021 diff hist -6 m HCmeddev Edited email address (removed "hc" and "sc" from beginning and end to reflect the correct address) Tag: Visual edit
- 12:19, 6 August 2021 diff hist +2 m SCinstrmed Updated Health Canada's Medical Devices Directorate Email Address Tag: Visual edit
- 12:18, 6 August 2021 diff hist +2 m HCmeddev Updated Health Canada's Medical Devices Directorate Email Address Tag: Visual edit
- 16:39, 18 June 2021 diff hist +55 SCinstrmed Addition: Règlement sur les instruments médicaux – Notification des risques survenus à l’étranger (juin 2021) Tag: Visual edit
- 16:38, 18 June 2021 diff hist +107 N File:Règlement post-commercialisation NRE FINAL Juin 2021.pdf Présentation: Règlement sur les instruments médicaux - Exigences de post-commercialisation current
- 15:15, 16 June 2021 diff hist +4 m SCinstrmed →Notification des risques survenus à l'étranger (NRE) Tag: Visual edit
- 15:14, 16 June 2021 diff hist -14 SCinstrmed Type-o correction Tag: Visual edit
- 15:14, 16 June 2021 diff hist -11 m HCmeddev Type-o correction Tag: Visual edit
- 14:52, 14 June 2021 diff hist 0 m SCinstrmed Corrected content Tag: Visual edit
- 14:52, 14 June 2021 diff hist 0 m HCmeddev Corrected content Tag: Visual edit
- 14:10, 10 June 2021 diff hist +41 m SCinstrmed Added FRN form in French Tag: Visual edit
- 14:09, 10 June 2021 diff hist +423 N File:SC instruments medicaux formulaire NRE V1 FR.pdf Ce formulaire est destiné à être utilisé par les fabricants et les importateurs afin de communiquer des renseignements concernant les mesures prises dans certaines juridictions étrangères pour éliminer ou atténuer un risque grave de préjudice à la santé humaine lié à l’utilisation d’un instrument médical, conformément aux articles 61.2 et 61.3 du Règlement sur les instruments médicaux. current
- 13:59, 10 June 2021 diff hist +25 m HCmeddev Uploaded FRN form in EN Tag: Visual edit
- 13:58, 10 June 2021 diff hist +329 N File:HC Medical Device FRN Form V1 EN.pdf This form is intended to be used by manufacturers and importers to report information concerning actions taken in certain foreign jurisdictions to eliminate or mitigate a serious risk of injury to human health related to the use of a medical device, as per sections 61.2 and 61.3 of the Medical Devices Regulations. current
- 16:15, 9 June 2021 diff hist +28 m HCmeddev Tag: Visual edit
- 16:14, 9 June 2021 diff hist +294 SCinstrmed Updated content Tag: Visual edit
- 15:57, 9 June 2021 diff hist +201 HCmeddev Content modifications Tag: Visual edit
- 15:51, 9 June 2021 diff hist 0 N File:Post-market regulations FRN FINAL June 2021.pdf current
- 15:48, 9 June 2021 diff hist +48 HCmeddev →Links to online resources Tag: Visual edit
- 13:15, 9 June 2021 diff hist +6 SCinstrmed Tag: Visual edit
- 13:15, 9 June 2021 diff hist -30 HCmeddev Tag: Visual edit
- 12:38, 9 June 2021 diff hist +696 SCinstrmed Addition of content Tag: Visual edit
- 12:29, 9 June 2021 diff hist -4 m HCmeddev Tag: Visual edit
- 12:28, 9 June 2021 diff hist +129 HCmeddev Addition of content Tag: Visual edit
- 12:13, 9 June 2021 diff hist +432 N File:FRM-0090 Autorisation relative à la présentation des rapports V22 FR.docx Autorisation relative à la présentation des rapports d’incident obligatoires, les communications étrangères relatives aux risques liés aux instruments médicaux et des rapports sur les rappels concernant des instruments médicaux, conformément aux articles 61.1, 61.3 et 65.1 du Règlement sur les instruments médicaux et/ou désignation pour agir à titre de contact en matière de réglementation canadienne current
- 12:09, 9 June 2021 diff hist +252 N File:FRM-0090 Authorization for medical devices mandatory problem foreign risk notification and recall reporting EN v22.docx Authorization for medical devices mandatory problem, foreign risk notification, and recall reporting according to sections 61.1, 61.3 and 65.1 of the Medical Devices Regulations and/or designation to Act as the Canadian regulatory contact current
- 12:06, 9 June 2021 diff hist +401 HCmeddev Uploading content Tag: Visual edit
- 09:39, 9 June 2021 diff hist +93 m HCmeddev Formatting Tag: Visual edit
- 14:50, 2 June 2021 diff hist 0 m SCinstrmed Tag: Visual edit
- 14:49, 2 June 2021 diff hist -28 m SCinstrmed →Diapositives de présentations Tag: Visual edit
- 16:05, 1 June 2021 diff hist -17 SCinstrmed
- 16:04, 1 June 2021 diff hist -17 HCmeddev
- 16:00, 1 June 2021 diff hist -1 m HCmeddev Tag: Visual edit
- 15:52, 1 June 2021 diff hist +35 m SCinstrmed Link to English page "SCmeddev" Tag: Visual edit
- 15:51, 1 June 2021 diff hist +37 m HCmeddev Link to French page "SCinstrmed" Tag: Visual edit
- 15:46, 1 June 2021 diff hist 0 N File:Questions and Answers FRN FINAL FR.pdf current
- 15:45, 1 June 2021 diff hist 0 N File:Deck Info Session Feb 2021 FINAL FR.pdf current
- 15:44, 1 June 2021 diff hist +1,713 N SCinstrmed Content added Tag: Visual edit
- 15:16, 1 June 2021 diff hist +231 HCmeddev Content added Tag: Visual edit
- 15:10, 1 June 2021 diff hist -2 HCmeddev →Links to guidance documents Tag: Visual edit
- 15:07, 1 June 2021 diff hist +329 N File:HC medical device FRN Form FINAL 2021-05-28.pdf This form is intended to be used by manufacturers and importers to report information concerning actions taken in certain foreign jurisdictions to eliminate or mitigate a serious risk of injury to human health related to the use of a medical device, as per sections 61.2 and 61.3 of the Medical Devices Regulations. current
- 15:05, 1 June 2021 diff hist +157 N File:Questions and Answers FRN FINAL EN.pdf A questions & answers document was prepared in response to enquiries received related to the implementation of foreign risk notification (FRN). current
- 15:04, 1 June 2021 diff hist +159 N File:Deck Info Session Feb 2021 FINAL EN.pdf Information sessions were offered by Health Canada in February 2021 on the new post-market regulations. The presentation slide deck is available. current
- 15:02, 1 June 2021 diff hist +86 HCmeddev →Links to guidance documents Tag: Visual edit
- 14:59, 1 June 2021 diff hist +738 HCmeddev Content added Tag: Visual edit
- 14:40, 1 June 2021 diff hist +341 N HCmeddev New page Tag: Visual edit
- 14:23, 1 June 2021 diff hist +293 N File:Guidance document links Post-Market FINAL FR.pdf Quatre ensembles de lignes directrices sont disponibles pour appuyer l'interprétation des dispositions post-commercialisation nouvelles ou mises à jour du Règlement sur les instruments médicaux qui ont été publiées dans la Gazette du Canada Partie II le 23 décembre 2020. current