27
edits
Changes
Medical devices – market authorization time / Instruments médicaux - temps d'autorisation de mise en marché (view source)
Revision as of 10:25, 7 February 2025
, 7 FebruaryJanuary 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> December / décembre 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> January / janvier 2025</th>
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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;"> 36.2 </td>
<td style="text-align:center;"> 29.3 </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;"> 16.7 </td>
<td style="text-align:center;"> 10.8 </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;"> 15.9 </td>
<td style="text-align:center;"> 20.8 </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;"> 171.2 </td>
<td style="text-align:center;"> 203.8 </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;"> 223.6 </td>
<td style="text-align:center;"> 203 </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;"> 162.9 </td>
<td style="text-align:center;"> 107.9 </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;"> 76 </td>
<td style="text-align:center;"> 146 </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;"> 338 </td>
<td style="text-align:center;"> 444.6 </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;"> 181 </td>
<td style="text-align:center;"> 174.6 </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;"> 71 </td>
<td style="text-align:center;"> 127 </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;"> 2 </td>
<td style="text-align:center;"> 1.2 </td>
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