https://wiki.gccollab.ca/index.php?action=history&feed=atom&title=Classification_des_instruments_m%C3%A9dicaux%2F
Classification des instruments médicaux/ - Revision history
2026-04-23T17:48:08Z
Revision history for this page on the wiki
MediaWiki 1.35.2
https://wiki.gccollab.ca/index.php?title=Classification_des_instruments_m%C3%A9dicaux/&diff=145046&oldid=prev
Diellza.mati at 15:02, 16 March 2026
2026-03-16T15:02:49Z
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Diellza.mati
https://wiki.gccollab.ca/index.php?title=Classification_des_instruments_m%C3%A9dicaux/&diff=145045&oldid=prev
Diellza.mati at 14:59, 16 March 2026
2026-03-16T14:59:26Z
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<td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 14:59, 16 March 2026</td>
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Diellza.mati
https://wiki.gccollab.ca/index.php?title=Classification_des_instruments_m%C3%A9dicaux/&diff=145044&oldid=prev
Diellza.mati at 14:57, 16 March 2026
2026-03-16T14:57:37Z
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<td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 14:57, 16 March 2026</td>
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<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>'<nowiki/>'''''Cliquez ci‑dessous pour lancer l’outil de classification''''''</div></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>'<nowiki/>'''''Cliquez ci‑dessous pour lancer l’outil de classification''''''</div></td></tr>
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Diellza.mati
https://wiki.gccollab.ca/index.php?title=Classification_des_instruments_m%C3%A9dicaux/&diff=145043&oldid=prev
Diellza.mati at 14:15, 16 March 2026
2026-03-16T14:15:47Z
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<td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 14:15, 16 March 2026</td>
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<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div><br></div></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div><br></div></td></tr>
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Diellza.mati
https://wiki.gccollab.ca/index.php?title=Classification_des_instruments_m%C3%A9dicaux/&diff=145042&oldid=prev
Diellza.mati at 14:14, 16 March 2026
2026-03-16T14:14:45Z
<p></p>
<table class="diff diff-contentalign-left diff-editfont-monospace" data-mw="interface">
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<td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 14:14, 16 March 2026</td>
</tr><tr><td colspan="2" class="diff-lineno" id="mw-diff-left-l1" >Line 1:</td>
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<tr><td class='diff-marker'>−</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>'''Cet outil vise à vous aider à déterminer la classification de votre instrument médical''' en vous guidant à travers les règles de classification prévues à l’annexe 1 du [https://laws-lois.justice.gc.ca/fra/reglements/DORS-98-282/TexteComplet.html Règlement sur les <del class="diffchange diffchange-inline">Instruments Médicaux</del>] (le Règlement). </div></td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>'''Cet outil vise à vous aider à déterminer la classification de votre instrument médical''' en vous guidant à travers les règles de classification prévues à l’annexe 1 du [https://laws-lois.justice.gc.ca/fra/reglements/DORS-98-282/TexteComplet.html Règlement sur les <ins class="diffchange diffchange-inline">instruments médicaux</ins>] (le Règlement). </div></td></tr>
<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td></tr>
<tr><td class='diff-marker'>−</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>Il vise uniquement à classer les produits qui répondent à la définition d’«instrument » au sens de la [https://laws-lois.justice.gc.ca/fra/lois/f-27/TexteComplet.html Loi sur les aliments et drogues] et <del class="diffchange diffchange-inline">d’« Instrument Médical » </del>dans l’une des classes I, II, III ou IV.<nowiki>''</nowiki></div></td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>Il vise uniquement à classer les produits qui répondent à la définition d’«instrument » au sens de la [https://laws-lois.justice.gc.ca/fra/lois/f-27/TexteComplet.html Loi sur les aliments et drogues] et <ins class="diffchange diffchange-inline">d’« instrument médical » </ins>dans l’une des classes I, II, III ou IV.<nowiki>''</nowiki></div></td></tr>
<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td></tr>
<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>Il ne permet pas de déterminer si votre produit n’est pas un instrument médical ni s’il relève d’une autre catégorie (p. ex., un médicament ou un produit de consommation).</div></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>Il ne permet pas de déterminer si votre produit n’est pas un instrument médical ni s’il relève d’une autre catégorie (p. ex., un médicament ou un produit de consommation).</div></td></tr>
<tr><td class='diff-marker'>−</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>Vous devez déterminer que votre produit répond à la définition <del class="diffchange diffchange-inline">d’« Instrument Médical » </del>avant d’utiliser cet outil.</div></td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>Vous devez déterminer que votre produit répond à la définition <ins class="diffchange diffchange-inline">d’« instrument médical » </ins>avant d’utiliser cet outil.</div></td></tr>
<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td></tr>
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Diellza.mati
https://wiki.gccollab.ca/index.php?title=Classification_des_instruments_m%C3%A9dicaux/&diff=144686&oldid=prev
Diellza.mati at 19:37, 4 March 2026
2026-03-04T19:37:38Z
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<td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 19:37, 4 March 2026</td>
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<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div><div style="text-align:center;"></div></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div><div style="text-align:center;"></div></td></tr>
<tr><td class='diff-marker'>−</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>'''''' Cliquez ci‑dessous pour lancer l’outil de classification''''''</div></td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>'<ins class="diffchange diffchange-inline"><nowiki/></ins>'''''Cliquez ci‑dessous pour lancer l’outil de classification''''''</div></td></tr>
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Diellza.mati
https://wiki.gccollab.ca/index.php?title=Classification_des_instruments_m%C3%A9dicaux/&diff=144452&oldid=prev
Diellza.mati: Created page with "'''Cet outil vise à vous aider à déterminer la classification de votre instrument médical''' en vous guidant à travers les règles de classification prévues à l’annex..."
2026-03-02T14:27:37Z
<p>Created page with "'''Cet outil vise à vous aider à déterminer la classification de votre instrument médical''' en vous guidant à travers les règles de classification prévues à l’annex..."</p>
<p><b>New page</b></p><div>'''Cet outil vise à vous aider à déterminer la classification de votre instrument médical''' en vous guidant à travers les règles de classification prévues à l’annexe 1 du [https://laws-lois.justice.gc.ca/fra/reglements/DORS-98-282/TexteComplet.html Règlement sur les Instruments Médicaux] (le Règlement). <br />
<br />
Il vise uniquement à classer les produits qui répondent à la définition d’«instrument » au sens de la [https://laws-lois.justice.gc.ca/fra/lois/f-27/TexteComplet.html Loi sur les aliments et drogues] et d’« Instrument Médical » dans l’une des classes I, II, III ou IV.<nowiki>''</nowiki><br />
<br />
Il ne permet pas de déterminer si votre produit n’est pas un instrument médical ni s’il relève d’une autre catégorie (p. ex., un médicament ou un produit de consommation).<br />
Vous devez déterminer que votre produit répond à la définition d’« Instrument Médical » avant d’utiliser cet outil.<br />
<br />
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<div style="text-align:center;"><br />
'''''' Cliquez ci‑dessous pour lancer l’outil de classification''''''<br />
<br><br />
[[File:Outil de classification.png|link=https://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUNDRZMFRVTTFFVlhSWFlJMFlZVFlWMUQ4Ni4u|200px]]<br />
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</div><br />
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'''Veuillez noter''' : l’outil fournira des indications en matière de classification uniquement en fonction des réponses que vous fournissez aux questions. Ces indications ne doivent pas être interprétées comme une décision finale de Santé Canada.<br />
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==Lignes directrices ==<br />
<br />
'''Les documents d’orientation suivants peuvent être consultés pour obtenir des définitions, des exemples et des renseignements supplémentaires sur l’interprétation des règles de classification :'''<br />
<br />
*[https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/information-demandes/lignes-directrices/ligne-directrice-orientation-systeme-classification-instruments.html Ligne directrice - Orientation sur le système de classification fondé sur le risque des instruments autres que les instruments diagnostiques in vitro (IDIV)]<br />
<br />
*[https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/information-demandes/lignes-directrices/ligne-directrice-orientation-systeme-classification-instruments-vitro.html Ligne directrice : Orientation pour le système de classification fondé sur le risque des instruments diagnostiques in vitro]<br />
<br />
'''''Pour les logiciels en tant qu’instruments médicaux (SaMD):''''<br />
<br />
'''Lorsque vous utilisez cet outil pour classifier les logiciels à titre d’instruments médicaux (SaMD), veuillez consulter les documents d’orientation sur les SaMD ci‑dessous afin de comprendre l’interprétation qu’a Santé Canada de termes tels que "danger immédiat" dans ce contexte.''' <br />
<br />
'''Vous pouvez souhaiter consulter la Direction des instruments médicaux afin de confirmer la classification de votre SaMD.'''<br />
<br />
*[https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/information-demandes/lignes-directrices/logiciels-titre-instruments-medicaux-ligne-directrice-document.html Ligne Directrice: Logiciels à titre d’instruments médicaux: Définition et Classification]<br />
*[https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/information-demandes/lignes-directrices/logiciels-titre-instruments-medicaux-ligne-directrice-document/exemples.html Ligne Directrice: Logiciels à titre d’instruments médicaux: Exemples de Classification]<br />
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*</div>
Diellza.mati