27
edits
Changes
Medical devices – market authorization time / Instruments médicaux - temps d'autorisation de mise en marché (view source)
Revision as of 10:10, 10 October 2025
, 10:10September 2025
<th style="text-align:center"bgcolor="#E8E8E8" height = "150" width="550"> Application Type <br><br> Type de demande </th>
<th style="text-align:center"bgcolor="#E8E8E8" height = "150" width="550"> Application Type <br><br> Type de demande </th>
<th style="text-align:center"bgcolor="#E8E8E8" height = "150" widt="225"> Average Market Authorizaton Time (days) <br> <br> Temps moyen d'autorisation de mise en marché (jours)
<th style="text-align:center"bgcolor="#E8E8E8" height = "150" widt="225"> Average Market Authorizaton Time (days) <br> <br> Temps moyen d'autorisation de mise en marché (jours)
<th style="text-align:center"bgcolor="#E8E8E8" height = "150"> Number of Decisions / Nombre de décisions <br> <br> August/août 2025</th>
<th style="text-align:center"bgcolor="#E8E8E8" height = "150"> Number of Decisions / Nombre de décisions <br> <br> September/septembre 2025</th>
</th>
</th>
</tr>
</tr>
<tr>
<tr>
<td style="text-align:left;"> Class II New Application / <br>Demande d'homologation classe II </td>
<td style="text-align:left;"> Class II New Application / <br>Demande d'homologation classe II </td>
<td style="text-align:center;"> 16.3 </td>
<td style="text-align:center;"> 14.1 </td>
<td style="text-align:center;"> 98 </td>
<td style="text-align:center;"> 91 </td>
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</tr>
<tr>
<tr>
<td style="text-align:left;"> Class II Amendment Application / <br>Demande de modification d'homologation classe II </td>
<td style="text-align:left;"> Class II Amendment Application / <br>Demande de modification d'homologation classe II </td>
<td style="text-align:center;"> 22.9 </td>
<td style="text-align:center;"> 22.7 </td>
<td style="text-align:center;"> 85 </td>
<td style="text-align:center;"> 91 </td>
</tr>
</tr>
<tr>
<tr>
<td style="text-align:left;"> Private label New and Amendment Application / <br>Marque privée - demande d'homologation ou demande de modification </td>
<td style="text-align:left;"> Private label New and Amendment Application / <br>Marque privée - demande d'homologation ou demande de modification </td>
<td style="text-align:center;"> 32 </td>
<td style="text-align:center;"> 38.3 </td>
<td style="text-align:center;"> 55 </td>
<td style="text-align:center;"> 46 </td>
</tr>
</tr>
<tr>
<tr>
<td style="text-align:left;"> Class III New Application / <br>Demande d'homologation classe III </td>
<td style="text-align:left;"> Class III New Application / <br>Demande d'homologation classe III </td>
<td style="text-align:center;"> 205.5 </td>
<td style="text-align:center;"> 209.3 </td>
<td style="text-align:center;"> 13 </td>
<td style="text-align:center;"> 16 </td>
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</tr>
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<td style="text-align:left;"> Class III New Application (near patient IVDD) / <br>Demande d'homologation classe III(Instrument diagnostique clinique in vitro) </td>
<td style="text-align:left;"> Class III New Application (near patient IVDD) / <br>Demande d'homologation classe III (Instrument diagnostique clinique in vitro)</td>
<td style="text-align:center;"> 378 </td>
<td style="text-align:center;"> NA </td>
<td style="text-align:center;"> 1 </td>
<td style="text-align:center;"> 0 </td>
</tr>
</tr>
<tr>
<tr>
<td style="text-align:left;"> Class III Amendment Application (significant change) / <br>Demande de modification d'homologation classe III (modification importante) </td>
<td style="text-align:left;"> Class III Amendment Application (significant change) / <br>Demande de modification d'homologation classe III (modification importante) </td>
<td style="text-align:center;"> 149.1 </td>
<td style="text-align:center;"> 131.0 </td>
<td style="text-align:center;"> 29 </td>
<td style="text-align:center;"> 21 </td>
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<td style="text-align:left;"> Class III Amendment Application(change in manufacturing) / <br>Demande de modification d'homologation classe III (Fabrication) </td>
<td style="text-align:left;"> Class III Amendment Application(change in manufacturing) / <br>Demande de modification d'homologation classe III (Fabrication) </td>
<td style="text-align:center;"> 179.6 </td>
<td style="text-align:center;"> 154 </td>
<td style="text-align:center;"> 5 </td>
<td style="text-align:center;"> 1 </td>
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</tr>
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<td style="text-align:left;"> Class IV New Application / <br>Demande d'homologation classe IV </td>
<td style="text-align:left;"> Class IV New Application / <br>Demande d'homologation classe IV </td>
<td style="text-align:center;"> 217.6 </td>
<td style="text-align:center;"> 225.8 </td>
<td style="text-align:center;"> 5 </td>
<td style="text-align:center;"> 5 </td>
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</tr>
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<td style="text-align:left;"> Class IV Amendment Application (significant change) / <br>Demande de modification d'homologation classe IV (modification importante) </td>
<td style="text-align:left;"> Class IV Amendment Application (significant change) / <br>Demande de modification d'homologation classe IV (modification importante) </td>
<td style="text-align:center;"> 117.1 </td>
<td style="text-align:center;"> 48 </td>
<td style="text-align:center;"> 14 </td>
<td style="text-align:center;"> 1 </td>
</tr>
</tr>
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<td style="text-align:left;"> Class IV Amendment Application(change in manufacturing) / <br>Demande de modification d'homologation classe IV(Fabrication) </td>
<td style="text-align:left;"> Class IV Amendment Application (change in manufacturing) / <br>Demande de modification d'homologation classe IV (Fabrication) </td>
<td style="text-align:center;"> 131 </td>
<td style="text-align:center;"> NA </td>
<td style="text-align:center;"> 7 </td>
<td style="text-align:center;"> 0 </td>
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<td style="text-align:left;"> Minor change / <br>Modification mineure </td>
<td style="text-align:left;"> Minor change / <br>Modification mineure </td>
<td style="text-align:center;"> 8.9 </td>
<td style="text-align:center;"> 13.5 </td>
<td style="text-align:center;"> 150 </td>
<td style="text-align:center;"> 134 </td>
</tr>
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</table>
</table>
<th style="text-align:center" bgcolor="#E8E8E8" height="150" width="550"> Application Type <br> <br> Type de demande </th>
<th style="text-align:center" bgcolor="#E8E8E8" height="150" width="550"> Application Type <br> <br> Type de demande </th>
<th style="text-align:center" bgcolor="#E8E8E8" height="150" width="225"> 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" width="225"> 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 <br> <br> August 2024 to August 2025 / De août 2024 à août 2025 </th>
<th style="text-align:center" bgcolor="#E8E8E8" height="150">Number of Decisions / Nombre de décisions <br> <br> September 2024 to September 2025 / De septembre 2024 à septembre 2025 </th>
</tr>
</tr>
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<tr>
<td style="text-align:left;"> Combination Products / Produits mixtes </td>
<td style="text-align:left;"> Combination Products / Produits mixtes </td>
<td style="text-align:center;"> 347 </td><td style="text-align:center;">4</td></tr></table>
<td style="text-align:center;"> 416.3 </td><td style="text-align:center;">3</td></tr></table>