Uploads by Hc.mdd.postmarket-postcommercialisation.dim.sc
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This special page shows all uploaded files.
| Date | Name | Thumbnail | Size | Description | Versions |
|---|---|---|---|---|---|
| 09:57, 7 September 2023 | Questions and Answers FRN FR 2023-09-07.pdf (file) |  |
323 KB | 1 | |
| 09:37, 7 September 2023 | Questions and Answers FRN EN 2023-09-07.pdf (file) | |
317 KB | 1 | |
| 10:12, 25 August 2022 | Rapports de synthèse - Conseils et astuces pour réussir (FR).pdf (file) | |
933 KB | 1 | |
| 10:10, 25 August 2022 | Summary Reports - Tips and Tricks for Success (EN).pdf (file) | |
936 KB | 1 | |
| 11:11, 11 March 2022 | Questions et réponses Rapport de synthèse GCwiki.pdf (file) | |
753 KB | 1 | |
| 11:07, 11 March 2022 | MedTech 2021 Rapports de synthèse GCwiki.pdf (file) | |
1.8 MB | 1 | |
| 10:55, 11 March 2022 | MedTech 2021 Summary Reports GCwiki.pdf (file) | |
1.69 MB | 1 | |
| 10:46, 11 March 2022 | Questions and Answers Summary Report GCwiki.pdf (file) | |
726 KB | 1 | |
| 18:58, 14 December 2021 | HC Medical Device FRN Form V2 FR.pdf (file) | |
2.28 MB | 1 | |
| 18:57, 14 December 2021 | Questions and Answers - FRN V2 FR.pdf (file) | |
898 KB | 1 | |
| 18:55, 14 December 2021 | Deck Post-market regulations - FRN - Jun 2021 V2 FR.pdf (file) | |
965 KB | 1 | |
| 18:54, 14 December 2021 | Deck Information Session - Feb 2021 V2 FR.pdf (file) | |
3.33 MB | 1 | |
| 16:43, 14 December 2021 | Questions and Answers – FRN V2 EN.pdf (file) | |
792 KB | 1 | |
| 16:37, 14 December 2021 | HC medical device FRN Form V2 EN.pdf (file) | |
1.94 MB | 1 | |
| 16:36, 14 December 2021 | Deck Post-market regulations – FRN – Jun 2021 V2 EN.pdf (file) | |
716 KB | 1 | |
| 16:33, 14 December 2021 | Deck Information Session – Feb 2021 V2 EN.pdf (file) | |
3.09 MB | 1 | |
| 16:29, 14 December 2021 | Deck Post-market regulations - FRN - Jun 2021 V2 EN.pdf (file) | |
716 KB | 1 | |
| 16:08, 14 December 2021 | Information session- Regulations amending the Medical Devices Regulations (February 2021) - V2.pdf (file) | |
2.89 MB | 1 | |
| 16:38, 18 June 2021 | Règlement post-commercialisation NRE FINAL Juin 2021.pdf (file) | |
1.27 MB | Présentation: Règlement sur les instruments médicaux - Exigences de post-commercialisation | 1 |
| 14:09, 10 June 2021 | SC instruments medicaux formulaire NRE V1 FR.pdf (file) | |
1.62 MB | 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. | 1 |
| 13:58, 10 June 2021 | HC Medical Device FRN Form V1 EN.pdf (file) | |
1.41 MB | 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. | 1 |
| 15:51, 9 June 2021 | Post-market regulations FRN FINAL June 2021.pdf (file) | |
882 KB | 1 | |
| 12:13, 9 June 2021 | FRM-0090 Autorisation relative à la présentation des rapports V22 FR.docx (file) |  |
113 KB | 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 | 1 |
| 12:09, 9 June 2021 | FRM-0090 Authorization for medical devices mandatory problem foreign risk notification and recall reporting EN v22.docx (file) | |
111 KB | 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 | 1 |
| 15:46, 1 June 2021 | Questions and Answers FRN FINAL FR.pdf (file) | |
1.3 MB | 1 | |
| 15:45, 1 June 2021 | Deck Info Session Feb 2021 FINAL FR.pdf (file) | |
3.1 MB | 1 | |
| 15:07, 1 June 2021 | HC medical device FRN Form FINAL 2021-05-28.pdf (file) | |
1.4 MB | 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. | 1 |
| 15:05, 1 June 2021 | Questions and Answers FRN FINAL EN.pdf (file) | |
1.24 MB | A questions & answers document was prepared in response to enquiries received related to the implementation of foreign risk notification (FRN). | 1 |
| 15:04, 1 June 2021 | Deck Info Session Feb 2021 FINAL EN.pdf (file) | |
2.89 MB | Information sessions were offered by Health Canada in February 2021 on the new post-market regulations. The presentation slide deck is available. | 1 |
| 14:23, 1 June 2021 | Guidance document links Post-Market FINAL FR.pdf (file) | |
707 KB | 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. | 1 |
| 14:20, 1 June 2021 | Guidance document links Post-Market FINAL EN.pdf (file) | |
680 KB | 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. | 1 |
