HL7 Vietnam VN Core FHIR Implementation Guide

Bộ Hướng dẫn Triển khai Core FHIR cho Việt Nam
0.5.0 - Draft for Community Review

Bộ Hướng dẫn Triển khai Core FHIR cho Việt Nam - Local Development build (v0.5.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

## Phần mở rộng: Số lưu hành thiết bị y tế — VN Device Registration Number - Hồ sơ XML

Draft tại thời điểm 2026-04-25

Biểu diễn XML của vn-ext-device-registration-number phần mở rộng.

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    <StructureDefinition xmlns="http://hl7.org/fhir">
      <id value="vn-ext-device-registration-number"/>
      <language value="vi"/>
      <text>
        <status value="extensions"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition vn-ext-device-registration-number</b></p><a name="vn-ext-device-registration-number"> </a><a name="hcvn-ext-device-registration-number"> </a><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description &amp; Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64, " alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-vn-ext-device-registration-number-definitions.html#Extension" title="Số lưu hành (registration number) của thiết bị y tế tại Việt Nam.

    **Căn cứ pháp lý**: NĐ 98/2021/NĐ-CP Điều 21 (Phân nhóm số lưu hành), Chương III (Điều 17-33) về đăng ký lưu hành TBYT, đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP (03/03/2023) và NĐ 04/2025/NĐ-CP (hiệu lực 01/01/2025).

    **Phân nhóm theo NĐ 98/2021 Điều 21**:

    1. **Loại A &amp; B — Số công bố tiêu chuẩn áp dụng** (Sở Y tế tỉnh/TP tiếp nhận):
       - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBA` (loại A)
       - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBB` (loại B)
       - PCBA/PCBB = Phiếu công bố loại A / loại B
       - Ví dụ: `2300001/23/HN-PCBA` (Hồ sơ số 1 năm 2023, Sở Y tế Hà Nội tiếp nhận)

    2. **Loại C &amp; D — Số Giấy chứng nhận đăng ký lưu hành** (Bộ Y tế cấp):
       - Format chuẩn: `[STT cấp]/[Năm cấp 2 số]/BYT-ĐKLH`
       - Format rút gọn: `[STT cấp]/BYT-ĐKLH`
       - ĐKLH = Đăng ký lưu hành
       - Ví dụ: `2300055/BYT-ĐKLH` hoặc `2300055/23/BYT-ĐKLH`

    **Phạm vi**:
    - Bắt buộc cho loại B/C/D trước khi đưa ra thị trường
    - Loại A chỉ công bố tiêu chuẩn áp dụng (vẫn dùng PCBA format)
    - Đây là định danh ở mức sản phẩm/model/regulatory context, KHÔNG phải định danh per-instance

    **Lưu ý phân biệt**: Extension này độc lập với:
    - UDI (định danh per-instance theo HL7 best practice)
    - MA_VAT_TU (mã nghiệp vụ BHYT theo QĐ 3176)
    - Serial number (per-instance physical)
    - Mã tài sản BV (internal facility code)">Extension</a><a name="Extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Số lưu hành thiết bị y tế — VN Device Registration Number</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a style="text-decoration:line-through; text-decoration:line-through" href="StructureDefinition-vn-ext-device-registration-number-definitions.html#Extension.extension">extension</a><a name="Extension.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Extension</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-vn-ext-device-registration-number-definitions.html#Extension.url">url</a><a name="Extension.url"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number&quot;</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-vn-ext-device-registration-number-definitions.html#Extension.value[x]">value[x]</a><a name="Extension.value_x_"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R4/conformance-rules.html#constraints" title="This element has or is affected by constraints ( vn-device-regnum-format )">C</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Số lưu hành TBYT (PCBA/PCBB cho loại A/B, ĐKLH cho loại C/D)<br class="constraint"/><span title="null" class="constraint">Constraints: </span><span style="font-weight:bold" title="Số lưu hành TBYT phải đúng 1 trong 3 format theo NĐ 98/2021 Điều 21:
    - Loại A (Sở Y tế cấp): [STT]/[Năm 2 số]/[Mã tỉnh]-PCBA — ví dụ 2300001/23/HN-PCBA
    - Loại B (Sở Y tế cấp): [STT]/[Năm 2 số]/[Mã tỉnh]-PCBB — ví dụ 2300002/23/HN-PCBB
    - Loại C/D (Bộ Y tế cấp): [STT]/[Năm 2 số]/BYT-ĐKLH hoặc [STT]/BYT-ĐKLH — ví dụ 2300055/23/BYT-ĐKLH" class="constraint">vn-device-regnum-format</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-vn-ext-device-registration-number-definitions.html#Extension.value[x].system">system</a><a name="Extension.value_x_.system"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The namespace for the identifier value</span><br/><span style="font-weight:bold">Fixed Value: </span><span style="color: darkgreen">http://fhir.hl7.org.vn/core/sid/medical-device-registration-number</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-vn-ext-device-registration-number-definitions.html#Extension.value[x].value" title="Format theo NĐ 98/2021 Điều 21: PCBA (loại A), PCBB (loại B) do Sở Y tế cấp; ĐKLH (loại C/D) do Bộ Y tế cấp.">value</a><a name="Extension.value_x_.value"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Giá trị số lưu hành</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-vn-ext-device-registration-number-definitions.html#Extension.value[x].assigner">assigner</a><a name="Extension.value_x_.assigner"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4/organization.html">Organization</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Cơ quan cấp (Sở Y tế cho A/B, Bộ Y tế cho C/D)</td></tr>
    <tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64, " alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
      </text>
      <url
           value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number"/>
      <version value="0.5.0"/>
      <name value="VNCoreExtDeviceRegistrationNumber"/>
      <title value="Số lưu hành thiết bị y tế — VN Device Registration Number"/>
      <status value="draft"/>
      <date value="2026-04-25"/>
      <publisher value="Omi HealthTech / VN Core FHIR Community Initiative"/>
      <contact>
        <name value="Omi HealthTech / VN Core FHIR Community Initiative"/>
        <telecom>
          <system value="url"/>
          <value value="https://hl7.org.vn"/>
        </telecom>
        <telecom>
          <system value="email"/>
          <value value="info@hl7.org.vn"/>
        </telecom>
      </contact>
      <contact>
        <name value="Omi HealthTech (OmiGroup)"/>
        <telecom>
          <system value="url"/>
          <value value="https://omihealthtech.vn"/>
        </telecom>
        <telecom>
          <system value="url"/>
          <value value="https://omigroup.vn"/>
        </telecom>
        <telecom>
          <system value="email"/>
          <value value="healthtech@omigroup.vn"/>
        </telecom>
      </contact>
      <description
                   value="Số lưu hành (registration number) của thiết bị y tế tại Việt Nam.

    **Căn cứ pháp lý**: NĐ 98/2021/NĐ-CP Điều 21 (Phân nhóm số lưu hành), Chương III (Điều 17-33) về đăng ký lưu hành TBYT, đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP (03/03/2023) và NĐ 04/2025/NĐ-CP (hiệu lực 01/01/2025).

    **Phân nhóm theo NĐ 98/2021 Điều 21**:

    1. **Loại A &amp; B — Số công bố tiêu chuẩn áp dụng** (Sở Y tế tỉnh/TP tiếp nhận):
       - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBA` (loại A)
       - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBB` (loại B)
       - PCBA/PCBB = Phiếu công bố loại A / loại B
       - Ví dụ: `2300001/23/HN-PCBA` (Hồ sơ số 1 năm 2023, Sở Y tế Hà Nội tiếp nhận)

    2. **Loại C &amp; D — Số Giấy chứng nhận đăng ký lưu hành** (Bộ Y tế cấp):
       - Format chuẩn: `[STT cấp]/[Năm cấp 2 số]/BYT-ĐKLH`
       - Format rút gọn: `[STT cấp]/BYT-ĐKLH`
       - ĐKLH = Đăng ký lưu hành
       - Ví dụ: `2300055/BYT-ĐKLH` hoặc `2300055/23/BYT-ĐKLH`

    **Phạm vi**:
    - Bắt buộc cho loại B/C/D trước khi đưa ra thị trường
    - Loại A chỉ công bố tiêu chuẩn áp dụng (vẫn dùng PCBA format)
    - Đây là định danh ở mức sản phẩm/model/regulatory context, KHÔNG phải định danh per-instance

    **Lưu ý phân biệt**: Extension này độc lập với:
    - UDI (định danh per-instance theo HL7 best practice)
    - MA_VAT_TU (mã nghiệp vụ BHYT theo QĐ 3176)
    - Serial number (per-instance physical)
    - Mã tài sản BV (internal facility code)"/>
      <jurisdiction>
        <coding>
          <system value="urn:iso:std:iso:3166"/>
          <code value="VN"/>
          <display value="Viet Nam"/>
        </coding>
      </jurisdiction>
      <copyright
                 value="Bộ Y tế Việt Nam — NĐ 98/2021/NĐ-CP ngày 08/11/2021 Chương III, đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP ngày 03/03/2023 và NĐ 04/2025/NĐ-CP hiệu lực 01/01/2025."/>
      <fhirVersion value="4.0.1"/>
      <mapping>
        <identity value="rim"/>
        <uri value="http://hl7.org/v3"/>
        <name value="RIM Mapping"/>
      </mapping>
      <kind value="complex-type"/>
      <abstract value="false"/>
      <context>
        <type value="element"/>
        <expression value="Device"/>
      </context>
      <context>
        <type value="element"/>
        <expression value="DeviceDefinition"/>
      </context>
      <type value="Extension"/>
      <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      <derivation value="constraint"/>
      <snapshot>
        <extension
                   url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version">
          <valueString value="4.0.1"/>
        </extension>
        <element id="Extension">
          <path value="Extension"/>
          <short
                 value="Số lưu hành thiết bị y tế — VN Device Registration Number"/>
          <definition
                      value="Số lưu hành (registration number) của thiết bị y tế tại Việt Nam.

    **Căn cứ pháp lý**: NĐ 98/2021/NĐ-CP Điều 21 (Phân nhóm số lưu hành), Chương III (Điều 17-33) về đăng ký lưu hành TBYT, đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP (03/03/2023) và NĐ 04/2025/NĐ-CP (hiệu lực 01/01/2025).

    **Phân nhóm theo NĐ 98/2021 Điều 21**:

    1. **Loại A &amp; B — Số công bố tiêu chuẩn áp dụng** (Sở Y tế tỉnh/TP tiếp nhận):
       - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBA` (loại A)
       - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBB` (loại B)
       - PCBA/PCBB = Phiếu công bố loại A / loại B
       - Ví dụ: `2300001/23/HN-PCBA` (Hồ sơ số 1 năm 2023, Sở Y tế Hà Nội tiếp nhận)

    2. **Loại C &amp; D — Số Giấy chứng nhận đăng ký lưu hành** (Bộ Y tế cấp):
       - Format chuẩn: `[STT cấp]/[Năm cấp 2 số]/BYT-ĐKLH`
       - Format rút gọn: `[STT cấp]/BYT-ĐKLH`
       - ĐKLH = Đăng ký lưu hành
       - Ví dụ: `2300055/BYT-ĐKLH` hoặc `2300055/23/BYT-ĐKLH`

    **Phạm vi**:
    - Bắt buộc cho loại B/C/D trước khi đưa ra thị trường
    - Loại A chỉ công bố tiêu chuẩn áp dụng (vẫn dùng PCBA format)
    - Đây là định danh ở mức sản phẩm/model/regulatory context, KHÔNG phải định danh per-instance

    **Lưu ý phân biệt**: Extension này độc lập với:
    - UDI (định danh per-instance theo HL7 best practice)
    - MA_VAT_TU (mã nghiệp vụ BHYT theo QĐ 3176)
    - Serial number (per-instance physical)
    - Mã tài sản BV (internal facility code)"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <condition value="ele-1"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <xpath
                   value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
        </element>
        <element id="Extension.id">
          <path value="Extension.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="Extension.extension">
          <path value="Extension.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Extension"/>
          <definition value="An Extension"/>
          <min value="0"/>
          <max value="0"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <xpath
                   value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="Extension.url">
          <path value="Extension.url"/>
          <representation value="xmlAttr"/>
          <short value="identifies the meaning of the extension"/>
          <definition
                      value="Source of the definition for the extension code - a logical name or a URL."/>
          <comment
                   value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Extension.url"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="uri"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <fixedUri
                    value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="Extension.value[x]">
          <path value="Extension.value[x]"/>
          <short
                 value="Số lưu hành TBYT (PCBA/PCBB cho loại A/B, ĐKLH cho loại C/D)"/>
          <definition
                      value="Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list)."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Extension.value[x]"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Identifier"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="vn-device-regnum-format"/>
            <severity value="warning"/>
            <human
                   value="Số lưu hành TBYT phải đúng 1 trong 3 format theo NĐ 98/2021 Điều 21:
    - Loại A (Sở Y tế cấp): [STT]/[Năm 2 số]/[Mã tỉnh]-PCBA — ví dụ 2300001/23/HN-PCBA
    - Loại B (Sở Y tế cấp): [STT]/[Năm 2 số]/[Mã tỉnh]-PCBB — ví dụ 2300002/23/HN-PCBB
    - Loại C/D (Bộ Y tế cấp): [STT]/[Năm 2 số]/BYT-ĐKLH hoặc [STT]/BYT-ĐKLH — ví dụ 2300055/23/BYT-ĐKLH"/>
            <expression
                        value="value.empty() or value.matches('^\\d+/\\d{2}/[A-Z]{2,3}-PCB[AB]$') or value.matches('^\\d+(/\\d{2})?/BYT-ĐKLH$')"/>
            <source
                    value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="Extension.value[x].id">
          <path value="Extension.value[x].id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="Extension.value[x].extension">
          <path value="Extension.value[x].extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <xpath
                   value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="Extension.value[x].use">
          <path value="Extension.value[x].use"/>
          <short value="usual | official | temp | secondary | old (If known)"/>
          <definition value="The purpose of this identifier."/>
          <comment
                   value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
          <requirements
                        value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Identifier.use"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="code"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one."/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="IdentifierUse"/>
            </extension>
            <strength value="required"/>
            <description
                         value="Identifies the purpose for this identifier, if known ."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/>
          </binding>
          <mapping>
            <identity value="v2"/>
            <map value="N/A"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="Role.code or implied by context"/>
          </mapping>
        </element>
        <element id="Extension.value[x].type">
          <path value="Extension.value[x].type"/>
          <short value="Description of identifier"/>
          <definition
                      value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
          <comment
                   value="This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.   Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
          <requirements
                        value="Allows users to make use of identifiers when the identifier system is not known."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Identifier.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="IdentifierType"/>
            </extension>
            <strength value="extensible"/>
            <description
                         value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type|4.0.1"/>
          </binding>
          <mapping>
            <identity value="v2"/>
            <map value="CX.5"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="Role.code or implied by context"/>
          </mapping>
        </element>
        <element id="Extension.value[x].system">
          <path value="Extension.value[x].system"/>
          <short value="The namespace for the identifier value"/>
          <definition
                      value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/>
          <comment value="Identifier.system is always case sensitive."/>
          <requirements
                        value="There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Identifier.system"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="uri"/>
          </type>
          <fixedUri
                    value="http://fhir.hl7.org.vn/core/sid/medical-device-registration-number"/>
          <example>
            <label value="General"/>
            <valueUri value="http://www.acme.com/identifiers/patient"/>
          </example>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="CX.4 / EI-2-4"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="II.root or Role.id.root"/>
          </mapping>
          <mapping>
            <identity value="servd"/>
            <map value="./IdentifierType"/>
          </mapping>
        </element>
        <element id="Extension.value[x].value">
          <path value="Extension.value[x].value"/>
          <short value="Giá trị số lưu hành"/>
          <definition
                      value="Format theo NĐ 98/2021 Điều 21: PCBA (loại A), PCBB (loại B) do Sở Y tế cấp; ĐKLH (loại C/D) do Bộ Y tế cấp."/>
          <comment
                   value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Identifier.value"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <example>
            <label value="General"/>
            <valueString value="123456"/>
          </example>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="CX.1 / EI.1"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map
                 value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
          </mapping>
          <mapping>
            <identity value="servd"/>
            <map value="./Value"/>
          </mapping>
        </element>
        <element id="Extension.value[x].period">
          <path value="Extension.value[x].period"/>
          <short value="Time period when id is/was valid for use"/>
          <definition
                      value="Time period during which identifier is/was valid for use."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Identifier.period"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Period"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="CX.7 + CX.8"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="Role.effectiveTime or implied by context"/>
          </mapping>
          <mapping>
            <identity value="servd"/>
            <map value="./StartDate and ./EndDate"/>
          </mapping>
        </element>
        <element id="Extension.value[x].assigner">
          <path value="Extension.value[x].assigner"/>
          <short value="Cơ quan cấp (Sở Y tế cho A/B, Bộ Y tế cho C/D)"/>
          <definition value="Organization that issued/manages the identifier."/>
          <comment
                   value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Identifier.assigner"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Organization|4.0.1"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <xpath value="@value|f:*|h:div"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="CX.4 / (CX.4,CX.9,CX.10)"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map
                 value="II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper"/>
          </mapping>
          <mapping>
            <identity value="servd"/>
            <map value="./IdentifierIssuingAuthority"/>
          </mapping>
        </element>
      </snapshot>
      <differential>
        <element id="Extension">
          <path value="Extension"/>
          <short
                 value="Số lưu hành thiết bị y tế — VN Device Registration Number"/>
          <definition
                      value="Số lưu hành (registration number) của thiết bị y tế tại Việt Nam.

    **Căn cứ pháp lý**: NĐ 98/2021/NĐ-CP Điều 21 (Phân nhóm số lưu hành), Chương III (Điều 17-33) về đăng ký lưu hành TBYT, đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP (03/03/2023) và NĐ 04/2025/NĐ-CP (hiệu lực 01/01/2025).

    **Phân nhóm theo NĐ 98/2021 Điều 21**:

    1. **Loại A &amp; B — Số công bố tiêu chuẩn áp dụng** (Sở Y tế tỉnh/TP tiếp nhận):
       - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBA` (loại A)
       - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBB` (loại B)
       - PCBA/PCBB = Phiếu công bố loại A / loại B
       - Ví dụ: `2300001/23/HN-PCBA` (Hồ sơ số 1 năm 2023, Sở Y tế Hà Nội tiếp nhận)

    2. **Loại C &amp; D — Số Giấy chứng nhận đăng ký lưu hành** (Bộ Y tế cấp):
       - Format chuẩn: `[STT cấp]/[Năm cấp 2 số]/BYT-ĐKLH`
       - Format rút gọn: `[STT cấp]/BYT-ĐKLH`
       - ĐKLH = Đăng ký lưu hành
       - Ví dụ: `2300055/BYT-ĐKLH` hoặc `2300055/23/BYT-ĐKLH`

    **Phạm vi**:
    - Bắt buộc cho loại B/C/D trước khi đưa ra thị trường
    - Loại A chỉ công bố tiêu chuẩn áp dụng (vẫn dùng PCBA format)
    - Đây là định danh ở mức sản phẩm/model/regulatory context, KHÔNG phải định danh per-instance

    **Lưu ý phân biệt**: Extension này độc lập với:
    - UDI (định danh per-instance theo HL7 best practice)
    - MA_VAT_TU (mã nghiệp vụ BHYT theo QĐ 3176)
    - Serial number (per-instance physical)
    - Mã tài sản BV (internal facility code)"/>
        </element>
        <element id="Extension.extension">
          <path value="Extension.extension"/>
          <max value="0"/>
        </element>
        <element id="Extension.url">
          <path value="Extension.url"/>
          <fixedUri
                    value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number"/>
        </element>
        <element id="Extension.value[x]">
          <path value="Extension.value[x]"/>
          <short
                 value="Số lưu hành TBYT (PCBA/PCBB cho loại A/B, ĐKLH cho loại C/D)"/>
          <type>
            <code value="Identifier"/>
          </type>
          <constraint>
            <key value="vn-device-regnum-format"/>
            <severity value="warning"/>
            <human
                   value="Số lưu hành TBYT phải đúng 1 trong 3 format theo NĐ 98/2021 Điều 21:
    - Loại A (Sở Y tế cấp): [STT]/[Năm 2 số]/[Mã tỉnh]-PCBA — ví dụ 2300001/23/HN-PCBA
    - Loại B (Sở Y tế cấp): [STT]/[Năm 2 số]/[Mã tỉnh]-PCBB — ví dụ 2300002/23/HN-PCBB
    - Loại C/D (Bộ Y tế cấp): [STT]/[Năm 2 số]/BYT-ĐKLH hoặc [STT]/BYT-ĐKLH — ví dụ 2300055/23/BYT-ĐKLH"/>
            <expression
                        value="value.empty() or value.matches('^\\d+/\\d{2}/[A-Z]{2,3}-PCB[AB]$') or value.matches('^\\d+(/\\d{2})?/BYT-ĐKLH$')"/>
            <source
                    value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number"/>
          </constraint>
        </element>
        <element id="Extension.value[x].system">
          <path value="Extension.value[x].system"/>
          <min value="1"/>
          <fixedUri
                    value="http://fhir.hl7.org.vn/core/sid/medical-device-registration-number"/>
        </element>
        <element id="Extension.value[x].value">
          <path value="Extension.value[x].value"/>
          <short value="Giá trị số lưu hành"/>
          <definition
                      value="Format theo NĐ 98/2021 Điều 21: PCBA (loại A), PCBB (loại B) do Sở Y tế cấp; ĐKLH (loại C/D) do Bộ Y tế cấp."/>
          <min value="1"/>
        </element>
        <element id="Extension.value[x].assigner">
          <path value="Extension.value[x].assigner"/>
          <short value="Cơ quan cấp (Sở Y tế cho A/B, Bộ Y tế cho C/D)"/>
        </element>
      </differential>
    </StructureDefinition>