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Medical devices – market authorization time / Instruments médicaux - temps d'autorisation de mise en marché (view source)
Revision as of 13:04, 26 June 2025
, 26 JuneMay 2025
<tr>
<tr>
<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> April/avril 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> May/mai 2025
</th>
</th>
</tr>
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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;"> 31.5 </td>
<td style="text-align:center;"> 23.6 </td>
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</tr>
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<tr>
<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;"> 16.6 </td>
<td style="text-align:center;"> 20.9 </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;"> 31.2 </td>
<td style="text-align:center;"> 22.5 </td>
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</tr>
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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;"> 274.5 </td>
<td style="text-align:center;"> 137.6 </td>
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</tr>
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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;"> 227 </td>
<td style="text-align:center;"> 330.7 </td>
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<tr>
<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;"> 144.9 </td>
<td style="text-align:center;"> 120.7 </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;"> 76.7 </td>
<td style="text-align:center;"> 134 </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;"> 152 </td>
<td style="text-align:center;"> 240.2 </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;"> 134.5 </td>
<td style="text-align:center;"> 141.4 </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;"> 105.2 </td>
<td style="text-align:center;"> 63.5 </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;"> 3.9 </td>
<td style="text-align:center;"> 4.6 </td>
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</tr>
</table>
</table>'''Combination Products / Produits mixtes'''<table border="1" cellspacing="0" cellpadding="0" width="800" align="center">
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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"> Average Market Authorizaton Time (days) <br> <br> Temps moyen d'autorisation de mise en marché (jours) <br>
</th><th style="text-align:center" bgcolor="#E8E8E8" height="150">Number of Decisions/ Nombre de décisions
May 2024 to May 2025 / De mai 2024 à mai 2025
</th></tr>
<tr>
<td style="text-align:left;"> Combination Products / <br> Produits mixtes </td>
<td style="text-align:center;"> 301.25 </td><td style="text-align:center;">4</td></tr></table>
