臺灣核心實作指引(TW Core IG)
0.3.0 - Ci-Build Trial Use

臺灣核心實作指引(TW Core IG), published by 衛生福利部. This guide is not an authorized publication; it is the continuous build for version 0.3.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cctwFHIRterm/MOHW_TWCoreIG_Build/ and changes regularly. See the Directory of published versions

: 臺灣食藥署醫療器材許可證 - XML Representation

Active as of 2024-06-06

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="medication-device-fda-tw"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem medication-device-fda-tw</b></p><a name="medication-device-fda-tw"> </a><a name="hcmedication-device-fda-tw"> </a><a name="medication-device-fda-tw-en-US"> </a><p><b>Properties</b></p><p><b>This code system defines the following properties for its concepts</b></p><table class="grid"><tr><td><b>Name</b></td><td><b>Code</b></td><td><b>URI</b></td><td><b>Type</b></td><td><b>Description</b></td></tr><tr><td>effectiveDate</td><td>effectiveDate</td><td>http://hl7.org/fhir/concept-properties#effectiveDate</td><td>dateTime</td><td>生效日期</td></tr><tr><td>status</td><td>status</td><td>http://hl7.org/fhir/concept-properties#status</td><td>code</td><td>狀態</td></tr></table><p><b>Concepts</b></p><p>This case-sensitive code system <code>https://twcore.mohw.gov.tw/ig/twcore/CodeSystem/medication-device-fda-tw</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>effectiveDate</b></td><td><b>status</b></td></tr><tr><td style="white-space:nowrap">許可證字號<a name="medication-device-fda-tw-.35377.21487.35657.23383.34399"> </a></td><td>中文品名</td><td>2024-06</td><td>active</td></tr><tr><td style="white-space:nowrap">衛部罕醫器輸字第000001號<a name="medication-device-fda-tw-.34907.37096.32597.37291.22120.36664.23383.31532000001.34399"> </a></td><td>&quot;沛佳&quot;法斯樂-杜瓦伸縮式髓內釘系統</td><td>2022-08</td><td>active</td></tr><tr><td style="white-space:nowrap">衛部醫器陸輸字第000506號<a name="medication-device-fda-tw-.34907.37096.37291.22120.38520.36664.23383.31532000506.34399"> </a></td><td>&quot;康德萊&quot;胰島素筆配套用針</td><td>2022-08</td><td>active</td></tr><tr><td style="white-space:nowrap">衛部醫器陸輸字第000507號<a name="medication-device-fda-tw-.34907.37096.37291.22120.38520.36664.23383.31532000507.34399"> </a></td><td>優盛電子體溫計</td><td>2022-08</td><td>active</td></tr><tr><td style="white-space:nowrap">衛部醫器陸輸字第000508號<a name="medication-device-fda-tw-.34907.37096.37291.22120.38520.36664.23383.31532000508.34399"> </a></td><td>&quot;勤達&quot;一次性使用無菌注射器帶針/不帶針</td><td>2022-08</td><td>active</td></tr><tr><td style="white-space:nowrap">衛部醫器陸輸字第000509號<a name="medication-device-fda-tw-.34907.37096.37291.22120.38520.36664.23383.31532000509.34399"> </a></td><td>&quot;帝寶&quot;紅外線耳溫槍</td><td>2022-08</td><td>active</td></tr><tr><td style="white-space:nowrap">衛部醫器陸輸字第000510號<a name="medication-device-fda-tw-.34907.37096.37291.22120.38520.36664.23383.31532000510.34399"> </a></td><td>&quot;華爾怡&quot;一次性使用全自動回縮型注射器(帶針)</td><td>2022-08</td><td>active</td></tr><tr><td style="white-space:nowrap">衛部醫器陸輸字第000521號<a name="medication-device-fda-tw-.34907.37096.37291.22120.38520.36664.23383.31532000521.34399"> </a></td><td>醫佳一次性使用真空採血管(無添加)</td><td>2022-08</td><td>active</td></tr><tr><td style="white-space:nowrap">衛部醫器陸輸字第000522號<a name="medication-device-fda-tw-.34907.37096.37291.22120.38520.36664.23383.31532000522.34399"> </a></td><td>嘉鎂一次性使用人體靜脈血樣採集容器(普通管)</td><td>2022-08</td><td>active</td></tr><tr><td style="white-space:nowrap">衛部醫器陸輸字第000523號<a name="medication-device-fda-tw-.34907.37096.37291.22120.38520.36664.23383.31532000523.34399"> </a></td><td>亞培輔理善越捷型血糖監測系統</td><td>2022-08</td><td>active</td></tr><tr><td style="white-space:nowrap">衛部醫器陸輸字第000524號<a name="medication-device-fda-tw-.34907.37096.37291.22120.38520.36664.23383.31532000524.34399"> </a></td><td>亞培輔理善越佳型血糖血酮監測系統</td><td>2022-08</td><td>active</td></tr><tr><td style="white-space:nowrap">衛部醫器陸輸字第000525號<a name="medication-device-fda-tw-.34907.37096.37291.22120.38520.36664.23383.31532000525.34399"> </a></td><td>醫凡一次性使用真空採血管(無添加)</td><td>2022-08</td><td>active</td></tr></table></div>
  </text>
  <url
       value="https://twcore.mohw.gov.tw/ig/twcore/CodeSystem/medication-device-fda-tw"/>
  <version value="2024-06-06"/>
  <name value="TWMedicationDeviceFDA"/>
  <title value="臺灣食藥署醫療器材許可證"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2024-06-06"/>
  <contact>
    <name value="衛生福利部"/>
    <telecom>
      <system value="url"/>
      <value value="https://www.mohw.gov.tw/"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="CCYU@mohw.gov.tw"/>
    </telecom>
  </contact>
  <description
               value="臺灣食藥署醫療器材許可證，參照自[https://data.fda.gov.tw/frontsite/data/DataAction.do?method=doDetail&amp;infoId=68](https://data.fda.gov.tw/frontsite/data/DataAction.do?method=doDetail&amp;infoId=68)  
代碼出版日期：2022-08-08；資料所屬單位：衛生福利部食品藥物管理署。

*因原始資料無代碼版本資訊，故使用其「更新日期」作為版本資訊。*

因代碼量較大會使載入頁面時間較長，為方便使用者瀏覽，此處(本頁、XML、JSON、TTL)僅擷取部分代碼，完整代碼可至[全國專門術語服務平臺－臺灣食藥署醫療器材許可證](https://fhir.mohw.gov.tw/ts/codesystemRead.jsp?id=medication-device-fda-tw&amp;status=active&amp;version=2022-08-08&amp;metaId=1&amp;codeStatus=use&amp;show=Y)查閱


* 2024/7/8異動說明：2024-06-06版的臺灣食藥署醫療器材許可證代碼中新增、刪除、修改代碼量較大會使載入頁面時間較長，完整異動代碼說明請至[全國專門術語服務平臺－臺灣食藥署醫療器材許可證](https://fhir.mohw.gov.tw/ts/codesystemRead.jsp?id=medication-device-fda-tw&amp;status=active&amp;version=2022-08-08&amp;metaId=1&amp;codeStatus=use&amp;show=Y)查閱。
"/>
  <copyright value="衛生福利部食品藥物管理署"/>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <count value="12"/>
  <property>
    <code value="effectiveDate"/>
    <uri value="http://hl7.org/fhir/concept-properties#effectiveDate"/>
    <description value="生效日期"/>
    <type value="dateTime"/>
  </property>
  <property>
    <code value="status"/>
    <uri value="http://hl7.org/fhir/concept-properties#status"/>
    <description value="狀態"/>
    <type value="code"/>
  </property>
  <concept>
    <code value="許可證字號"/>
    <display value="中文品名"/>
    <property>
      <code value="effectiveDate"/>
      <valueDateTime value="2024-06"/>
    </property>
    <property>
      <code value="status"/>
      <valueCode value="active"/>
    </property>
  </concept>
  <concept>
    <code value="衛部罕醫器輸字第000001號"/>
    <display value="&quot;沛佳&quot;法斯樂-杜瓦伸縮式髓內釘系統"/>
    <property>
      <code value="effectiveDate"/>
      <valueDateTime value="2022-08"/>
    </property>
    <property>
      <code value="status"/>
      <valueCode value="active"/>
    </property>
  </concept>
  <concept>
    <code value="衛部醫器陸輸字第000506號"/>
    <display value="&quot;康德萊&quot;胰島素筆配套用針"/>
    <property>
      <code value="effectiveDate"/>
      <valueDateTime value="2022-08"/>
    </property>
    <property>
      <code value="status"/>
      <valueCode value="active"/>
    </property>
  </concept>
  <concept>
    <code value="衛部醫器陸輸字第000507號"/>
    <display value="優盛電子體溫計"/>
    <property>
      <code value="effectiveDate"/>
      <valueDateTime value="2022-08"/>
    </property>
    <property>
      <code value="status"/>
      <valueCode value="active"/>
    </property>
  </concept>
  <concept>
    <code value="衛部醫器陸輸字第000508號"/>
    <display value="&quot;勤達&quot;一次性使用無菌注射器帶針/不帶針"/>
    <property>
      <code value="effectiveDate"/>
      <valueDateTime value="2022-08"/>
    </property>
    <property>
      <code value="status"/>
      <valueCode value="active"/>
    </property>
  </concept>
  <concept>
    <code value="衛部醫器陸輸字第000509號"/>
    <display value="&quot;帝寶&quot;紅外線耳溫槍"/>
    <property>
      <code value="effectiveDate"/>
      <valueDateTime value="2022-08"/>
    </property>
    <property>
      <code value="status"/>
      <valueCode value="active"/>
    </property>
  </concept>
  <concept>
    <code value="衛部醫器陸輸字第000510號"/>
    <display value="&quot;華爾怡&quot;一次性使用全自動回縮型注射器(帶針)"/>
    <property>
      <code value="effectiveDate"/>
      <valueDateTime value="2022-08"/>
    </property>
    <property>
      <code value="status"/>
      <valueCode value="active"/>
    </property>
  </concept>
  <concept>
    <code value="衛部醫器陸輸字第000521號"/>
    <display value="醫佳一次性使用真空採血管(無添加)"/>
    <property>
      <code value="effectiveDate"/>
      <valueDateTime value="2022-08"/>
    </property>
    <property>
      <code value="status"/>
      <valueCode value="active"/>
    </property>
  </concept>
  <concept>
    <code value="衛部醫器陸輸字第000522號"/>
    <display value="嘉鎂一次性使用人體靜脈血樣採集容器(普通管)"/>
    <property>
      <code value="effectiveDate"/>
      <valueDateTime value="2022-08"/>
    </property>
    <property>
      <code value="status"/>
      <valueCode value="active"/>
    </property>
  </concept>
  <concept>
    <code value="衛部醫器陸輸字第000523號"/>
    <display value="亞培輔理善越捷型血糖監測系統"/>
    <property>
      <code value="effectiveDate"/>
      <valueDateTime value="2022-08"/>
    </property>
    <property>
      <code value="status"/>
      <valueCode value="active"/>
    </property>
  </concept>
  <concept>
    <code value="衛部醫器陸輸字第000524號"/>
    <display value="亞培輔理善越佳型血糖血酮監測系統"/>
    <property>
      <code value="effectiveDate"/>
      <valueDateTime value="2022-08"/>
    </property>
    <property>
      <code value="status"/>
      <valueCode value="active"/>
    </property>
  </concept>
  <concept>
    <code value="衛部醫器陸輸字第000525號"/>
    <display value="醫凡一次性使用真空採血管(無添加)"/>
    <property>
      <code value="effectiveDate"/>
      <valueDateTime value="2022-08"/>
    </property>
    <property>
      <code value="status"/>
      <valueCode value="active"/>
    </property>
  </concept>
</CodeSystem>