27
edits
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Medical devices – market authorization time / Instruments médicaux - temps d'autorisation de mise en marché (view source)
Revision as of 09:30, 4 April 2025
, 4 AprilMarch 2025
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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> February/février 2025
<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> March/mars 2025
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</tr><td style="text-align:left;"> Class II New Application / Demande d'homologation classe II </td>
<td style="text-align:center;"> 34.6 </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;"> 11.6 </td>
<td style="text-align:center;"> 15.5 </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;"> 18.7 </td>
<td style="text-align:center;"> 53.4 </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;"> 153 </td>
<td style="text-align:center;"> 191.8 </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;"> 428 </td>
<td style="text-align:center;"> N/A </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;"> 137.7 </td>
<td style="text-align:center;"> 189.5 </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;"> 101 </td>
<td style="text-align:center;"> 56.6 </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;"> 260.6 </td>
<td style="text-align:center;"> 150.6 </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;"> 132.3 </td>
<td style="text-align:center;"> 114.7 </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;"> 157.5 </td>
<td style="text-align:center;"> 37 </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;"> 1.5 </td>
<td style="text-align:center;"> 2.6 </td>
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