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 - JSON Representation

Active as of 2024-06-06

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{
  "resourceType" : "CodeSystem",
  "id" : "medication-device-fda-tw",
  "text" : {
    "status" : "generated",
    "div" : "<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>"
  },
  "url" : "https://twcore.mohw.gov.tw/ig/twcore/CodeSystem/medication-device-fda-tw",
  "version" : "2024-06-06",
  "name" : "TWMedicationDeviceFDA",
  "title" : "臺灣食藥署醫療器材許可證",
  "status" : "active",
  "experimental" : false,
  "date" : "2024-06-06",
  "contact" : [
    {
      "name" : "衛生福利部",
      "telecom" : [
        {
          "system" : "url",
          "value" : "https://www.mohw.gov.tw/"
        },
        {
          "system" : "email",
          "value" : "CCYU@mohw.gov.tw"
        }
      ]
    }
  ],
  "description" : "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&infoId=68](https://data.fda.gov.tw/frontsite/data/DataAction.do?method=doDetail&infoId=68)  \n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。\n\n*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。*\n\n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&status=active&version=2022-08-08&metaId=1&codeStatus=use&show=Y)查閱\n\n\n* 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&status=active&version=2022-08-08&metaId=1&codeStatus=use&show=Y)查閱。\n",
  "copyright" : "衛生福利部食品藥物管理署",
  "caseSensitive" : true,
  "content" : "complete",
  "count" : 12,
  "property" : [
    {
      "code" : "effectiveDate",
      "uri" : "http://hl7.org/fhir/concept-properties#effectiveDate",
      "description" : "生效日期",
      "type" : "dateTime"
    },
    {
      "code" : "status",
      "uri" : "http://hl7.org/fhir/concept-properties#status",
      "description" : "狀態",
      "type" : "code"
    }
  ],
  "concept" : [
    {
      "code" : "許可證字號",
      "display" : "中文品名",
      "property" : [
        {
          "code" : "effectiveDate",
          "valueDateTime" : "2024-06"
        },
        {
          "code" : "status",
          "valueCode" : "active"
        }
      ]
    },
    {
      "code" : "衛部罕醫器輸字第000001號",
      "display" : "\"沛佳\"法斯樂-杜瓦伸縮式髓內釘系統",
      "property" : [
        {
          "code" : "effectiveDate",
          "valueDateTime" : "2022-08"
        },
        {
          "code" : "status",
          "valueCode" : "active"
        }
      ]
    },
    {
      "code" : "衛部醫器陸輸字第000506號",
      "display" : "\"康德萊\"胰島素筆配套用針",
      "property" : [
        {
          "code" : "effectiveDate",
          "valueDateTime" : "2022-08"
        },
        {
          "code" : "status",
          "valueCode" : "active"
        }
      ]
    },
    {
      "code" : "衛部醫器陸輸字第000507號",
      "display" : "優盛電子體溫計",
      "property" : [
        {
          "code" : "effectiveDate",
          "valueDateTime" : "2022-08"
        },
        {
          "code" : "status",
          "valueCode" : "active"
        }
      ]
    },
    {
      "code" : "衛部醫器陸輸字第000508號",
      "display" : "\"勤達\"一次性使用無菌注射器帶針/不帶針",
      "property" : [
        {
          "code" : "effectiveDate",
          "valueDateTime" : "2022-08"
        },
        {
          "code" : "status",
          "valueCode" : "active"
        }
      ]
    },
    {
      "code" : "衛部醫器陸輸字第000509號",
      "display" : "\"帝寶\"紅外線耳溫槍",
      "property" : [
        {
          "code" : "effectiveDate",
          "valueDateTime" : "2022-08"
        },
        {
          "code" : "status",
          "valueCode" : "active"
        }
      ]
    },
    {
      "code" : "衛部醫器陸輸字第000510號",
      "display" : "\"華爾怡\"一次性使用全自動回縮型注射器(帶針)",
      "property" : [
        {
          "code" : "effectiveDate",
          "valueDateTime" : "2022-08"
        },
        {
          "code" : "status",
          "valueCode" : "active"
        }
      ]
    },
    {
      "code" : "衛部醫器陸輸字第000521號",
      "display" : "醫佳一次性使用真空採血管(無添加)",
      "property" : [
        {
          "code" : "effectiveDate",
          "valueDateTime" : "2022-08"
        },
        {
          "code" : "status",
          "valueCode" : "active"
        }
      ]
    },
    {
      "code" : "衛部醫器陸輸字第000522號",
      "display" : "嘉鎂一次性使用人體靜脈血樣採集容器(普通管)",
      "property" : [
        {
          "code" : "effectiveDate",
          "valueDateTime" : "2022-08"
        },
        {
          "code" : "status",
          "valueCode" : "active"
        }
      ]
    },
    {
      "code" : "衛部醫器陸輸字第000523號",
      "display" : "亞培輔理善越捷型血糖監測系統",
      "property" : [
        {
          "code" : "effectiveDate",
          "valueDateTime" : "2022-08"
        },
        {
          "code" : "status",
          "valueCode" : "active"
        }
      ]
    },
    {
      "code" : "衛部醫器陸輸字第000524號",
      "display" : "亞培輔理善越佳型血糖血酮監測系統",
      "property" : [
        {
          "code" : "effectiveDate",
          "valueDateTime" : "2022-08"
        },
        {
          "code" : "status",
          "valueCode" : "active"
        }
      ]
    },
    {
      "code" : "衛部醫器陸輸字第000525號",
      "display" : "醫凡一次性使用真空採血管(無添加)",
      "property" : [
        {
          "code" : "effectiveDate",
          "valueDateTime" : "2022-08"
        },
        {
          "code" : "status",
          "valueCode" : "active"
        }
      ]
    }
  ]
}