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Medical devices – market authorization time / Instruments médicaux - temps d'autorisation de mise en marché (view source)
Revision as of 10:16, 15 December 2025
, 15 DecemberNovember 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> October/octobre 2025</th>
<th style="text-align:center"bgcolor="#E8E8E8" height = "150"> Number of Decisions / Nombre de décisions <br> <br> November/novembre 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;"> 13.6 </td>
<td style="text-align:center;"> 15.8 </td>
<td style="text-align:center;"> 128 </td>
<td style="text-align:center;"> 108 </td>
</tr>
</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;"> 22.1 </td>
<td style="text-align:center;"> 21.4 </td>
<td style="text-align:center;"> 101 </td>
<td style="text-align:center;"> 74 </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;"> 33.2 </td>
<td style="text-align:center;"> 28 </td>
<td style="text-align:center;"> 67 </td>
<td style="text-align:center;"> 32 </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;"> 175.8 </td>
<td style="text-align:center;"> 167.6 </td>
<td style="text-align:center;"> 34 </td>
<td style="text-align:center;"> 22 </td>
</tr>
</tr>
<tr>
<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;"> NA </td>
<td style="text-align:center;"> 239 </td>
<td style="text-align:center;"> 0 </td>
<td style="text-align:center;"> 1 </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;"> 123.3 </td>
<td style="text-align:center;"> 129.4 </td>
<td style="text-align:center;"> 33 </td>
<td style="text-align:center;"> 30 </td>
</tr>
</tr>
<tr>
<tr>
<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;"> 88 </td>
<td style="text-align:center;"> 195.6 </td>
<td style="text-align:center;"> 5 </td>
<td style="text-align:center;"> 3 </td>
</tr>
</tr>
<tr>
<tr>
<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;"> 276.8 </td>
<td style="text-align:center;"> 260.5 </td>
<td style="text-align:center;"> 8 </td>
<td style="text-align:center;"> 2 </td>
</tr>
</tr>
<tr>
<tr>
<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;"> 128.7 </td>
<td style="text-align:center;"> 231.6 </td>
<td style="text-align:center;"> 11 </td>
<td style="text-align:center;"> 9 </td>
</tr>
</tr>
<tr>
<tr>
<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;"> 78.4 </td>
<td style="text-align:center;"> 92.6 </td>
<td style="text-align:center;"> 9 </td>
<td style="text-align:center;"> 3 </td>
</tr>
</tr>
<tr>
<tr>
<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;"> 18.1 </td>
<td style="text-align:center;"> 6.8 </td>
<td style="text-align:center;"> 347 </td>
<td style="text-align:center;"> 184 </td>
</tr>
</tr>
</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> October 2024 to October 2025 / D'octobre 2024 à octobre 2025 </th>
<th style="text-align:center" bgcolor="#E8E8E8" height="150">Number of Decisions / Nombre de décisions <br> <br> December 2024 to November 2025 / De décembre 2024 à novembre 2025 </th>
</tr>
</tr>
<tr>
<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;"> 416.3 </td><td style="text-align:center;">3</td></tr></table>
<td style="text-align:center;"> 416.3 </td><td style="text-align:center;">3</td></tr></table>
