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Medical Device Import & Export in Vietnam

Risk-classified import and export of medical devices and IVDs under Decree 98/2021/NĐ-CP as amended by Decree 07/2023/NĐ-CP and Decree 04/2025/NĐ-CP, the IMDA registration regime, the Hague Apostille Convention from 11 September 2026, and the open WTO regime for foreign-invested distributors — a fully separate legal chain from the drug regime.

Overview

Medical-device import and export in Vietnam runs on a wholly separate legal chain from the drug regime described in the Medibase Drug Import & Export page. The directorate, the governing decree, the marketing-authorisation document, the risk-classification framework, the dossier format, the customs workflow, and — most consequentially for foreign sponsors — the foreign-invested-enterprise (FIE) commercial scope are all different. Practitioners who project the drug regime onto medical devices will get the rules systematically wrong.

Two key differences from the drug regime:

  • Different directorate. Medical-device regulation is led by Cục Hạ tầng và Thiết bị y tế (IMDA), the medical-device directorate under the Ministry of Health — not the Drug Administration of Vietnam (DAV). IMDA was renamed in 2025 from the prior Cục Cơ sở Hạ tầng và Thiết bị y tế and earlier from the Vụ Trang thiết bị và Công trình y tế; its current portal is imda.moh.gov.vn, live since 1 January 2025 (the legacy dmec.moh.gov.vn portal ran in parallel through end-2024).
  • Open FIE commercial scope. Foreign-invested enterprises may directly import, wholesale, retail, lease, install, warranty and service medical devices in Vietnam — there is no WTO-commitment restriction equivalent to the pharmacy regime's Article 53a. Law 44/2024/QH15, which restricts pharma-FIE rights, does not extend to medical devices.

See: Medibase Drug Import & Export — for the parallel pharmaceutical framework — at /medicine/import-export/.

Scope of this page:

  • Authority structure: IMDA, Sở Y tế, customs, and the 2024–2025 directorate reorganisation.
  • Legal stack: Decree 98/2021 + amendments 07/2023 and 04/2025; Circulars 05/2022 (classification), 19/2021 and 10/2023 (dossier), and 44/2025 (decentralisation).
  • Risk classification A–D under the ASEAN AMDD-aligned 16-rule self-classification regime in Circular 05/2022.
  • Marketing-authorisation registration: Class A/B self-declaration of conformity and Class C/D Marketing Authorisation Certificate, including the ASEAN CSDT mandatory format and the Reference-Country fast-track pathway.
  • Import requirements per class, plus non-commercial imports (clinical trial, research, donation, exhibition, personal use).
  • Foreign-owner-authorised representative requirement.
  • Documentary requirements (CFS, ISO 13485, foreign approval evidence) and the apostille milestone of 11 September 2026.
  • Open FIE commercial scope.
  • Customs procedure and sanctions.
  • Export — Vietnamese-issued CFS by IMDA.

Authority structure:

  • Cục Hạ tầng và Thiết bị y tế (IMDA), Bộ Y tế — the central medical-device directorate. Issues Class C/D Marketing Authorisation Certificates, maintains the device registry at imda.moh.gov.vn, runs the Reference-Country fast-track pathway, and issues the Vietnamese CFS for exports.
  • Sở Y tế cấp tỉnh — receives Class A/B self-declarations of conformity ("công bố tiêu chuẩn áp dụng") and issues the corresponding number ("số lưu hành Class A/B").
  • Tổng cục Hải quan — clears import shipments against the registration number declared in the customs dossier; under Decree 04/2025/NĐ-CP, customs verifies the classification result on the MOH portal before release.

Legal stack (current):

  • Decree 98/2021/NĐ-CP — primary medical-device decree. Issued 8 November 2021; effective 1 January 2022. Ten chapters covering definitions, classification, manufacture, registration (số lưu hành) and standard declaration, trading conditions, import and export (Chapter VI, Articles 46–48 plus transitional Article 76), clinical trials, price management, information and advertising, and transitional provisions.
  • Decree 07/2023/NĐ-CP — amends Decree 98/2021. Issued 3 March 2023. Extended validity of pre-2022 import permits and IVD registration numbers; reformed the price-declaration regime; revised Articles 46 and 48 on import management; clarified that the Ministry of Health does not issue import permits for used devices.
  • Decree 04/2025/NĐ-CP — further amends Decree 98/2021 (as already amended). Issued and effective 1 January 2025. Amends Article 76: customs cross-verifies classification on the MOH portal; legacy IVD registration numbers (granted 2014–2019) and old import permits extended to 30 June 2025.
  • Circular 05/2022/TT-BYT — classification rules. Issued 2 August 2022. Sixteen classification rules in Part II of Appendix I; superseded the earlier Circular 39/2016/TT-BYT.
  • Circular 19/2021/TT-BYT — registration dossier templates. Issued 16 November 2021. Amended by Circular 10/2023/TT-BYT (11 May 2023). The ASEAN Common Submission Dossier Template (CSDT) format has been mandatory for Class C/D dossiers since January 2024.
  • Circular 44/2025/TT-BYT — decentralisation of Ministry of Health administrative procedures for medical devices. Issued 22 November 2025.

Risk classification (A, B, C, D): Article 4 of Decree 98/2021/NĐ-CP aligns Vietnamese classification with the ASEAN Medical Device Directive (AMDD): four classes from A (lowest risk — e.g. gauze, basic examination instruments) through B (e.g. syringe, glucose meter), C (e.g. infusion pump, ventilator, dental implant), to D (highest risk — e.g. implantable cardiac devices, life-support equipment). Classification is performed by the registration holder using the sixteen rules in Part II of Appendix I to Circular 05/2022/TT-BYT — Vietnam moved from Ministry-assigned to self-classification with the 2022 circular. The result is recorded on the MOH portal and verified by customs under Decree 04/2025.

Marketing-authorisation registration:

  • Class A and B: Self-declaration of conformity (công bố tiêu chuẩn áp dụng) filed via the MOH electronic portal. Sở Y tế of the province where the registration holder is based issues the số lưu hành. Application form templates in Circular 19/2021/TT-BYT as amended.
  • Class C and D: Marketing Authorisation Certificate (Giấy chứng nhận đăng ký lưu hành) issued by IMDA. Standard pathway uses the ASEAN Common Submission Dossier Template (CSDT) — mandatory for Class C/D since January 2024.
  • Reference-Country fast-track: Decree 98/2021 (as amended) provides a shortened review for Class C/D devices that hold authorisation in a recognised Reference Country — currently US FDA, EU CE, Japan PMDA, Australia TGA, Health Canada, China NMPA, and Korea MFDS. Reference-Country approval does not waive Vietnamese registration; it shortens the review timeline.

Import requirements: A Vietnamese registration number (số lưu hành) is the baseline. A separate import permit beyond the registration number is required only for legacy categories listed under Article 48 of Decree 98/2021 as amended by Decree 07/2023/NĐ-CP. At customs:

  • Class A/B: số lưu hành / công bố number plus classification result verified on the MOH portal.
  • Class C/D: số lưu hành Class C/D number; for fast-track imports, the corresponding fast-track permit.
  • Used medical devices: the Ministry of Health does not issue import permits for used devices; the general foreign-trade management law prohibits commercial and personal import of used medical devices.
  • Non-commercial imports (clinical trial, scientific research, donation, exhibition, personal use): governed by Article 47 of Decree 98/2021 with separate Ministry of Health-issued permits and case-specific dossiers.

Foreign-owner-authorised representative: Foreign manufacturers cannot directly hold a Vietnamese số lưu hành. Eligible registration holders under Decree 98/2021 are: a Vietnamese enterprise that owns the device; a Vietnamese enterprise expressly authorised by the foreign owner ("đại diện được chủ sở hữu số lưu hành ủy quyền"); or a permanent representative office in Vietnam of the foreign merchant. The authorisation document is part of the dossier. The public registry of all registered devices and their authorised representatives is available at imda.moh.gov.vn.

Documentary requirements and the apostille milestone: Foreign dossiers for Class C/D imports typically include a Certificate of Free Sale (CFS) from the country of manufacture (two-year validity), the device-specific regulatory approval evidence (FDA 510(k)/PMA, CE certificate, PMDA approval, TGA, Health Canada or equivalent), and an ISO 13485 quality-system certificate. The CFS must be legalised or apostilled for use in Vietnam.

Apostille milestone — 11 September 2026: Vietnam deposited its instrument of accession to the 1961 Hague Apostille Convention on 31 December 2025; the Convention enters into force for Vietnam on 11 September 2026. Until that date, foreign-issued CFS and related public documents must continue to be legalised by Vietnamese consular missions in the issuing country. From 11 September 2026, an apostille issued by the competent authority of a Convention member state replaces consular legalisation for documents originating from that state. Documents from non-member states continue to require consular legalisation. The same milestone applies to both medical-device documents and pharmaceutical documents — there is no medical-device carve-out.

Open FIE commercial scope (the contrast with drugs): 100 %-foreign-owned enterprises may directly engage in every commercial stage of the medical-device value chain in Vietnam — import, wholesale, retail, lease, install, warranty, and after-sales service. There is no WTO-commitment restriction equivalent to the pharmacy regime's Article 53a (which requires foreign-sponsor distribution to flow through Vietnamese-owned wholesalers). Decree 98/2021 and its amendments operate on the assumption of open FIE access; the Investment Law and the Enterprise Law govern the establishment of FIE entities. This is the single most consequential strategic difference for foreign device manufacturers planning their Vietnamese market entry.

Customs procedure and sanctions:

  • Most medical devices are classified under HS Chapter 90 (optical, photographic, measuring, checking, precision and medical or surgical instruments and apparatus). Some IVD reagents fall under HS Chapter 38 (miscellaneous chemical products) and certain dressings under HS Chapter 30. The customs declaration includes the registration number, the classification result that customs verifies on the MOH portal (per Decree 04/2025), the legalised or apostilled CFS, and the authorised-representative documentation.
  • Administrative penalties: Decree 117/2020/NĐ-CP, as amended by Decree 124/2021/NĐ-CP, covers medical-equipment violations in the healthcare sector, with maximum penalty of VND 100 million for an individual and VND 200 million for an organisation, plus corrective measures including revocation of import permits.
  • Customs penalties: Decree 128/2020/NĐ-CP covers mis-declaration, HS-code error and labelling breaches at clearance, with penalties up to three times the evaded tax.

Export: IMDA issues a Vietnamese Certificate of Free Sale (CFS) for Class C/D medical devices manufactured in Vietnam that hold a Vietnamese số lưu hành. CFS validity is three years; IMDA issues within three working days of a complete dossier via imda.moh.gov.vn and the national public-services portal dichvucong.gov.vn. ISO 13485 quality-system certification is issued by accredited third-party certification bodies — the Ministry of Health does not run a national ISO 13485 scheme.

Key documents

Primary decree and amendments:

  • Decree 98/2021/NĐ-CP — primary medical-device decree. Issued 8 November 2021; effective 1 January 2022. Ten chapters; Chapter VI (Articles 46–48 + transitional Article 76) covers import and export.
  • Decree 07/2023/NĐ-CP — amends Decree 98/2021. Issued 3 March 2023. Revised Articles 46 and 48; extended legacy permit validity; clarified that the Ministry of Health does not issue import permits for used devices.
  • Decree 04/2025/NĐ-CP — further amends Decree 98/2021 (as amended). Issued and effective 1 January 2025. Amends Article 76 to require customs to cross-verify classification on the MOH portal; extended legacy registration and permit validity to 30 June 2025.

Circulars:

  • Circular 05/2022/TT-BYT — classification rules. Issued 2 August 2022. Sixteen rules in Part II of Appendix I; superseded Circular 39/2016/TT-BYT.
  • Circular 19/2021/TT-BYT — registration dossier templates. Issued 16 November 2021. Amended by Circular 10/2023/TT-BYT (11 May 2023). ASEAN CSDT format for Class C/D dossiers from January 2024.
  • Circular 10/2023/TT-BYT — amends Circular 19/2021 dossier templates. Issued 11 May 2023.
  • Circular 44/2025/TT-BYT — decentralisation of Ministry of Health administrative procedures for medical devices. Issued 22 November 2025.

Customs:

  • Customs Law 54/2014/QH13 — effective 1 January 2015; the umbrella statute for customs clearance.

International:

  • 1961 Hague Apostille Convention. Vietnam acceded 31 December 2025; in force from 11 September 2026. Replaces consular legalisation of CFS and similar documents from Convention member states for medical-device imports.

Penalties:

  • Decree 117/2020/NĐ-CP — administrative penalties in the healthcare field; medical-equipment chapter with maximum VND 100 million / VND 200 million fines plus corrective measures including revocation of import permits. Amended by Decree 124/2021/NĐ-CP.
  • Decree 128/2020/NĐ-CP — administrative penalties in customs.

Source documents

Direct links to the official text on government portals.

Decrees:

Circulars:

  • Circular 05/2022/TT-BYT (classification) — see IMDA portal and thuvienphapluat.vn.
  • Circular 19/2021/TT-BYT (dossier templates) — see IMDA portal.
  • Circular 10/2023/TT-BYT (amends TT 19/2021) — see thuvienphapluat.vn.
  • Circular 44/2025/TT-BYT (decentralisation) — see Bộ Y tế portal.

Operational portals:

Customs:

International:

Penalties:

Medibase cross-references:

  • Reference — Drug Import & Export (parallel framework) — /medicine/import-export/
  • Reference — Risk Classification — /medical-device/risk-classification/
  • Reference — Market Access & Licensing — /medical-device/market-access/
  • Reference — Registration Process — /medical-device/registration/

Recent updates

8 November 2021 — Government issues Decree 98/2021/NĐ-CP, the primary medical-device decree.

16 November 2021 — Ministry of Health issues Circular 19/2021/TT-BYT on registration dossier templates.

1 January 2022 — Decree 98/2021 enters into force.

2 August 2022 — Ministry of Health issues Circular 05/2022/TT-BYT setting the sixteen classification rules; supersedes Circular 39/2016/TT-BYT.

3 March 2023 — Government issues Decree 07/2023/NĐ-CP amending Decree 98/2021.

11 May 2023 — Ministry of Health issues Circular 10/2023/TT-BYT amending Circular 19/2021 on dossier templates.

January 2024 — ASEAN Common Submission Dossier Template (CSDT) format becomes mandatory for Class C/D dossiers.

1 January 2025 — Decree 04/2025/NĐ-CP enters into force; IMDA portal imda.moh.gov.vn goes live (legacy dmec.moh.gov.vn parallel through end-2024).

30 June 2025 — Legacy IVD registration numbers and old import permits expire (extended by Decree 04/2025).

22 November 2025 — Ministry of Health issues Circular 44/2025/TT-BYT decentralising medical-device administrative procedures.

31 December 2025 — Vietnam deposits its instrument of accession to the 1961 Hague Apostille Convention.

11 September 2026 — Apostille Convention enters into force for Vietnam; apostille replaces consular legalisation for medical-device CFS originating from Convention member states.

Resources & links

Operational portals:

  • IMDA — Cục Hạ tầng và Thiết bị y tế (Infrastructure and Medical Device Administration, Ministry of Health) — https://imda.moh.gov.vn — main agency portal for Class C/D registration, classification verification, foreign-manufacturer registry, and Vietnamese CFS export.
  • Legacy DMEC portal (run in parallel through 31 December 2024) — https://dmec.moh.gov.vn
  • Sở Y tế cấp tỉnh — Class A/B self-declaration of conformity reception; e.g. Sở Y tế Hà Nội (https://soyte.hanoi.gov.vn), Sở Y tế TP. HCM (https://medinet.gov.vn).
  • Vietnam General Department of Customs — https://www.customs.gov.vn — customs procedure, HS-code lookup, and clearance support.
  • Cục Lãnh sự (Consular Department, Ministry of Foreign Affairs) — https://lanhsuvietnam.gov.vn — consular legalisation procedure (through 10 September 2026); from 11 September 2026, designated apostille issuing authorities.
  • National public-services portal — https://dichvucong.gov.vn — Vietnamese CFS export application interface.

Legal text portals:

  • Cổng thông tin điện tử Chính phủ — văn bản pháp luật — https://vanban.chinhphu.vn
  • Công báo điện tử — https://congbao.chinhphu.vn
  • Thư viện pháp luật — https://thuvienphapluat.vn
  • Cổng pháp luật quốc gia (Bộ Tư pháp) — https://vbpl.vn

International:

  • Hague Conference on Private International Law (HCCH) — https://www.hcch.net — 1961 Apostille Convention depository and competent-authority lists.

Medibase cross-references:

  • Reference — Drug Import & Export (parallel framework for contrast) — /medicine/import-export/
  • Reference — Risk Classification — /medical-device/risk-classification/
  • Reference — Market Access & Licensing — /medical-device/market-access/
  • Reference — Registration Process — /medical-device/registration/

Frequently asked questions

医療機器制度と医薬品制度の根本的な相違は何か？

3つ。第一に、所管局：医療機器規制は IMDA（Cục Hạ tầng và Thiết bị y tế）が主導し、DAV ではない。第二に、法令体系：Nghị định 98/2021/NĐ-CP（Nghị định 07/2023 および 04/2025 により改正）と Thông tư 05/2022、19/2021、10/2023、44/2025 — Luật Dược 105/2016、Luật 44/2024、Nghị định 163/2025 は適用されない。第三に、FIE 商業範囲：外資系企業は医療機器を直接、輸入、卸売、小売、リース、設置、保証、保守することができ、医薬品制度第53a条に相当する WTO 約束による制限はない。

医療機器の販売承認はどの機関が発給するか？

Class A および B 機器については、登録保有者の所在地の省 Sở Y tế が適合自己宣言を受領し số lưu hành を発給する。Class C および D 機器については、IMDA（Cục Hạ tầng và Thiết bị y tế）が販売承認証（Giấy chứng nhận đăng ký lưu hành）を発給する。Reference Country ファストトラックも IMDA が処理する。通関は保健省ポータルで分類結果を検証する Tổng cục Hải quan が実施する。

A/B/C/D リスク区分はどう運用されるか？

ベトナムは ASEAN AMDD の4区分方式に従う：A（最低、例：ガーゼ、基本器具）、B（例：注射器、血糖計）、C（例：輸液ポンプ、人工呼吸器）、D（最高、例：埋込型心臓装置、生命維持装置）。分類は登録保有者が Thông tư 05/2022/TT-BYT 附属書 I 第II部の16規則を用いて行う — ベトナムは2022年通達で保健省指定方式から自己分類方式に移行した。区分は機器が Class A/B 自己宣言経路に従うか Class C/D 販売承認経路に従うかを決定する。

外資系企業は直接医療機器を輸入し小売できるか？

はい。医薬品制度と異なり、医療機器制度には外資系商業範囲について WTO 約束による制限はない。100 % 外国所有企業はベトナムで医療機器を直接、輸入、卸売、小売、リース、設置、保証、保守することができる。Nghị định 98/2021 は開放的な FIE アクセスを前提に運用される；Luật Đầu tư（投資法）および Luật Doanh nghiệp（企業法）が事業者設立を規律する。Luật 44/2024（医薬品 FIE 制限）は医療機器には適用されない。

アポスティーユは医療機器 CFS の領事認証をいつから代替するか？

2026年9月11日から — 2025年12月31日の加盟書寄託後、1961年ハーグ・アポスティーユ条約がベトナムに対し発効する日。条約加盟国の権限機関により発行されたアポスティーユは、その国を発行国とする文書について領事認証を代替する。非加盟国からの文書はベトナム在外公館による領事認証を引き続き要する。同じマイルストンが医療機器 CFS と医薬品 CPP の両方に適用される — 医療機器の carve-out はない。医療機器固有の実施を明確化する保健省または IMDA の移行通知は2026年内の公表が見込まれる。

Page changelog

2026-06-28: Initial publication. Reflects Decree 98/2021/NĐ-CP (as amended by Decree 07/2023 and Decree 04/2025), Circulars 05/2022/TT-BYT (classification), 19/2021/TT-BYT and 10/2023/TT-BYT (dossier templates), and 44/2025/TT-BYT (decentralisation), the Customs Law 54/2014/QH13, and the 1961 Hague Apostille Convention (in force for Vietnam 11 September 2026).

Effective from:
2025-01-01
Last reviewed:
2026-06-28
Page updated:
2026-06-28

Reference information only; not legal or medical advice.