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Medical devices – market authorization time / Instruments médicaux - temps d'autorisation de mise en marché (view source)
Revision as of 11:15, 13 January 2025
, 13 JanuaryDecember 2024
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<th style="text-align:center" bgcolor="#E8E8E8" height="150"> Application Type / Type de demande </th>
<th style="text-align:center"bgcolor="#E8E8E8" height = "150"> Application Type / Type de demande </th>
<th style="text-align:center" bgcolor="#E8E8E8" height="150"> Average Market Authorizaton Time (days) <br> <br> Temps moyen d'autorisation de mise en marché (jours) <br> <br> November / novembre 2024
<th style="text-align:center"bgcolor="#E8E8E8" height = "150"> Average Market Authorizaton Time (days) <br> <br> Temps moyen d'autorisation de mise en marché (jours) <br> <br> December / décembre 2024
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<td style="text-align:left;"> Class II New Application / Demande d'homologation classe II </td>
<td style="text-align:left;"> Class II New Application / Demande d'homologation classe II </td>
<td style="text-align:center;"> 42.9 </td>
<td style="text-align:center;"> 36.2 </td>
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<td style="text-align:left;"> Class II Amendment Application / Demande de modification d'homologation classe II </td>
<td style="text-align:left;"> Class II Amendment Application / Demande de modification d'homologation classe II </td>
<td style="text-align:center;"> 20.9 </td>
<td style="text-align:center;"> 16.7 </td>
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<td style="text-align:left;"> Private label New and Amendment Application / Marque privée - demande d'homologation ou demande de modification</td>
<td style="text-align:left;"> Private label New and Amendment Application / Marque privée - demande d'homologation ou demande de modification </td>
<td style="text-align:center;"> 37.6 </td>
<td style="text-align:center;"> 15.9 </td>
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<td style="text-align:left;"> Class III New Application / Demande d'homologation classe III </td>
<td style="text-align:left;"> Class III New Application / Demande d'homologation classe III </td>
<td style="text-align:center;"> 212.0 </td>
<td style="text-align:center;"> 171.2 </td>
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<td style="text-align:left;"> Class III New Application (near patient IVDD) / Demande d'homologation classe III(Instrument diagnostique clinique in vitro) </td>
<td style="text-align:left;"> Class III New Application (near patient IVDD) / Demande d'homologation classe III(Instrument diagnostique clinique in vitro) </td>
<td style="text-align:center;"> 338.0 </td>
<td style="text-align:center;"> 223.6 </td>
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<td style="text-align:left;"> Class III Amendment Application (significant change) / Demande de modification d'homologation classe III (modification importante) </td>
<td style="text-align:left;"> Class III Amendment Application (significant change) / Demande de modification d'homologation classe III (modification importante) </td>
<td style="text-align:center;"> 131.4 </td>
<td style="text-align:center;"> 162.9 </td>
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<td style="text-align:left;"> Class III Amendment Application(change in manufacturing) / Demande de modification d'homologation classe III (Fabrication) </td>
<td style="text-align:left;"> Class III Amendment Application(change in manufacturing) / Demande de modification d'homologation classe III (Fabrication) </td>
<td style="text-align:center;"> 98.0 </td>
<td style="text-align:center;"> 76 </td>
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<td style="text-align:left;"> Class IV New Application / Demande d'homologation classe IV </td>
<td style="text-align:left;"> Class IV New Application / Demande d'homologation classe IV </td>
<td style="text-align:center;"> 293.4 </td>
<td style="text-align:center;"> 338 </td>
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<td style="text-align:left;"> Class IV Amendment Application (significant change) / Demande de modification d'homologation classe IV (modification importante) </td>
<td style="text-align:left;"> Class IV Amendment Application (significant change) / Demande de modification d'homologation classe IV (modification importante) </td>
<td style="text-align:center;"> 182.7 </td>
<td style="text-align:center;"> 181 </td>
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<td style="text-align:left;"> Class IV Amendment Application(change in manufacturing) / Demande de modification d'homologation classe IV(Fabrication) </td>
<td style="text-align:left;"> Class IV Amendment Application(change in manufacturing) / Demande de modification d'homologation classe IV(Fabrication) </td>
<td style="text-align:center;"> 73.6 </td>
<td style="text-align:center;"> 71 </td>
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<td style="text-align:left;"> Minor change / Modification mineure </td>
<td style="text-align:left;"> Minor change / Modification mineure </td>
<td style="text-align:center;"> 3.5 </td>
<td style="text-align:center;"> 2 </td>
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