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Medical devices – market authorization time / Instruments médicaux - temps d'autorisation de mise en marché (view source)
Revision as of 16:21, 8 August 2025
, 8 AugustJuly 2025
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<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"> 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" width="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> June/juin 2025</th>
<th style="text-align:center"bgcolor="#E8E8E8" height = "150"> Number of Decisions / Nombre de décisions <br> <br> July/juillet 2025</th>
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<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;"> 10.1 </td>
<td style="text-align:center;"> 14.6 </td>
<td style="text-align:center;"> 113 </td>
<td style="text-align:center;"> 98 </td>
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<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;"> 19 </td>
<td style="text-align:center;"> 22 </td>
<td style="text-align:center;"> 85 </td>
<td style="text-align:center;"> 111 </td>
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<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;"> 12.5 </td>
<td style="text-align:center;"> 31.7 </td>
<td style="text-align:center;"> 61 </td>
<td style="text-align:center;"> 42 </td>
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<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;"> 163.2 </td>
<td style="text-align:center;"> 243.25 </td>
<td style="text-align:center;"> 35 </td>
<td style="text-align:center;"> 12 </td>
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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;"> NA </td>
<td style="text-align:center;"> NA </td>
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<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;"> 134.8 </td>
<td style="text-align:center;"> 133.9 </td>
<td style="text-align:center;"> 48 </td>
<td style="text-align:center;"> 36 </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;"> 86.7 </td>
<td style="text-align:center;"> 101 </td>
<td style="text-align:center;"> 4 </td>
<td style="text-align:center;"> 3 </td>
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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;"> 271.7 </td>
<td style="text-align:center;"> 59 </td>
<td style="text-align:center;"> 4 </td>
<td style="text-align:center;"> 2 </td>
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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;"> 92.9 </td>
<td style="text-align:center;"> 138.9 </td>
<td style="text-align:center;"> 12 </td>
<td style="text-align:center;"> 20 </td>
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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;"> 170 </td>
<td style="text-align:center;"> 115 </td>
<td style="text-align:center;"> 1 </td>
<td style="text-align:center;"> 3 </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;"> 7.1 </td>
<td style="text-align:center;"> 6.2 </td>
<td style="text-align:center;"> 221 </td>
<td style="text-align:center;"> 284 </td>
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<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"> 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> June 2024 to June 2025 / De juin 2024 à juin 2025 </th>
<th style="text-align:center" bgcolor="#E8E8E8" height="150">Number of Decisions / Nombre de décisions <br> <br> July 2024 to July 2025 / De juillet 2024 à juillet 2025 </th>
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<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;"> 301.25 </td><td style="text-align:center;">4</td></tr></table>
<td style="text-align:center;"> 307.8 </td><td style="text-align:center;">5</td></tr></table>