User contributions
14 December 2021
13 August 2021
SCinstrmed
Edited email address (removed "hc" and "sc" from beginning and end to reflect the correct address)
m-6
HCmeddev
Edited email address (removed "hc" and "sc" from beginning and end to reflect the correct address)
m-6
6 August 2021
SCinstrmed
Updated Health Canada's Medical Devices Directorate Email Address
m+2
HCmeddev
Updated Health Canada's Medical Devices Directorate Email Address
m+2
18 June 2021
SCinstrmed
Addition: Règlement sur les instruments médicaux – Notification des risques survenus à l’étranger (juin 2021)
+55
File:Règlement post-commercialisation NRE FINAL Juin 2021.pdf
Présentation: Règlement sur les instruments médicaux - Exigences de post-commercialisation
16 June 2021
SCinstrmed
Notification des risques survenus à l'étranger (NRE)
m+4
SCinstrmed
Type-o correction
-14
HCmeddev
Type-o correction
m-11
14 June 2021
10 June 2021
SCinstrmed
Added FRN form in French
m+41
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.
HCmeddev
Uploaded FRN form in EN
m+25
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.
9 June 2021
HCmeddev
no edit summary
m+28
SCinstrmed
Updated content
+294
HCmeddev
Content modifications
+201
File:Post-market regulations FRN FINAL June 2021.pdf
no edit summary
HCmeddev
Links to online resources
+48
SCinstrmed
no edit summary
+6
HCmeddev
no edit summary
-30
SCinstrmed
Addition of content
+696
HCmeddev
no edit summary
m-4
HCmeddev
Addition of content
+129
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
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
HCmeddev
Uploading content
+401
HCmeddev
Formatting
m+93
2 June 2021
1 June 2021
SCinstrmed
no edit summary
-17
HCmeddev
no edit summary
-17
HCmeddev
no edit summary
m-1
SCinstrmed
Link to English page "SCmeddev"
m+35
HCmeddev
Link to French page "SCinstrmed"
m+37
File:Questions and Answers FRN FINAL FR.pdf
no edit summary
File:Deck Info Session Feb 2021 FINAL FR.pdf
no edit summary
SCinstrmed
Content added
HCmeddev
Content added
+231
HCmeddev
Links to guidance documents
-2
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.
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).
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.
HCmeddev
Links to guidance documents
+86
HCmeddev
Content added
+738
HCmeddev
New page
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.
File:Guidance document links Post-Market FINAL EN.pdf
Four guidance documents are available to support the interpretation of the new or updated post-market provisions in the Medical Devices Regulations that were published in Canada Gazette Part II on December 23, 2020.