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Ministry of Health · structured requirements

🇻🇳 Vietnam IVD regulatory data

Explore the IVD requirements currently available for Vietnam, organized by topic and linked to official sources.

13 facts7 dimensions4 official sourceslatest verification 2026-10-21

Changes after registration

Explore questions and sources →

Common questions about changing a registered IVD in Vietnam. Each question separates published rules from details still awaiting verification.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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A/B cessation or bankruptcy is a separate stock procedure

answers.ab-cessation-stock
Fact-level verified

The retained A/B procedure in2075/QĐ-BYT requires the holder/distributor commitment dossier no later than60 days after the specified cessation, bankruptcy or dissolution event. The provincial health authority answers within 15 working days of a valid dossier; continued circulation is limited to24 months under the stated warranty/maintenance/material-support commitments, including the eight-year support wording and its exceptions. This is not an ordinary rename or transfer grace.

Conditions
  • This record is A/B only; it does not inherit a C/D procedure.
  • Use the current prescribed form where applicable; the historical administrative decision and later form framework are distinct.
Văn bản hợp nhất số 08/VBHN-BYT hợp nhất Nghị định 98/2021/NĐ-CP quy định về quản lý thiết bị y tế

Class A/B updates and fresh-declaration triggers

answers.ab-name-office-label-route
Fact-level verified

For Class A/B devices and IVDs, Article28(4) lists name/address updates for the product owner or circulation-number holder and manufacturer name/address information, plus qualifying label/IFU changes. Notify with related documents and update the public dossier within five working days after the change. A new product owner, device kind/type/purpose, added manufacturing site or added product code instead triggers a fresh declaration under 28(3).

Conditions
  • Label/IFU route requires unchanged intended purpose and indications.
  • A commercial brand is not automatically a new device type or product owner.

Class C/D updates and new-registration triggers

answers.cd-name-office-label-route
Fact-level verified

For Class C/D devices and IVDs, Article 32(7) lists owner/holder name and address, manufacturer name/address, packaging, warranty and qualifying label/IFU updates. Notify with related documents and update the public dossier within ten working days. Article29(1)(b) requires a new circulation number for the listed substantive changes, including a new product owner or added product code, and changes outside32(7).

Conditions
  • Label/IFU updates require unchanged purpose, indications, functionality and performance.
  • Ten working days is the holder notification deadline, not an authority approval SLA.

Existing stock after a qualifying label notice

answers.label-stock-predicate
Fact-level verified

Articles28(4)(e) and32(7)(e) permit devices manufactured before the holder gives the qualifying label-change notice to continue circulating with the information declared/registered and updated at manufacture. A/B must keep intended purpose and indications unchanged; C/D must also keep functionality and performance unchanged. This is not a general stock grace after a new product-owner transfer or a substantive code/type change.

REF mapping and an actual registered code change

answers.ref-code-trigger
Fact-level verified

First map a commercial order REF to the declared or registered product code/type and label. An added product code triggers a fresh A/B declaration or C/D circulation-number application under 28(3)/29(1)(b); A/B reductions are specifically listed under 28(4)(g). Article 32a permits a priority request where the old code was discontinued and the prescribed device-type facts remain unchanged. Its ten-working-day decision is priority acceptance, not final registration approval.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Separate A/B export CFS application

answers.ab-export-cfs
Fact-level verified

The retained A/B CFS procedure in2075/QĐ-BYT uses the provincial health authority, an application with owner/manufacturer/device/brand/code/circulation-number information and valid ISO 13485 evidence in the prescribed form. The procedure gives up to three working days from a complete proper dossier, with inspection possible where document review is insufficient. It is an export certificate requested to meet an importing-country requirement, not an automatic reissue after every logo or name edit.

Conditions
  • This A/B procedure is retained separately from the replaced C/D procedures.
  • The printed ISO1348 typo on physical16 is read with ISO 13485 on17; no raw text rewritten.
Văn bản hợp nhất số 08/VBHN-BYT hợp nhất Nghị định 98/2021/NĐ-CP quy định về quản lý thiết bị y tế

Separate C/D export CFS application

answers.cd-export-cfs
Fact-level verified

The C/D CFS procedure in3618/QĐ-BYT directs Form 11 under Circular44/2025 and the quality-certificate evidence to IMDA. It gives up to three working days from a complete proper dossier, allows inspection where needed and lists a VND 500000 export-dossier fee in the temporary fee framework. The form distinguishes owner, applicant, manufacturer, device type/code and circulation number. It is separate from change notification and does not itself require CFS reissue for every change.

Conditions
  • The listed VND 500000 is read in the 64/2025 reduction window through31 December2026, not a perpetual fee.
Văn bản hợp nhất số 08/VBHN-BYT hợp nhất Nghị định 98/2021/NĐ-CP quy định về quản lý thiết bị y tế

Documents when the change triggers a new route

answers.new-route-materials
Fact-level verified

A fresh A/B dossier under 26-27 includes the applicable ISO 13485, owner authorisation, warranty evidence, technical description/standards, IFU, label and current imported-device CFS. Reagent/calibrator/control IVDs have their specifically listed technical and quality evidence. A new C/D dossier follows its Article 30 route and31 document/legalisation requirements, including the applicable CSDT and IVD quality certificate branches. Apply current Circular44 forms and owner-LOA/warranty templates.

Conditions
  • Only apply a new-dossier checklist where the actual change triggers that route; it is not the materials list for every label notification.
  • Warranty and route-specific exemptions must be preserved.
Thông tư 44/2025/TT-BYT quy định về phân cấp và mẫu văn bản, báo cáo trong lĩnh vực thiết bị y tế

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

Compare countries

A new product owner is different from a name update

answers.owner-transfer-new-route
Fact-level verified

A real change of product owner triggers a fresh A/B declaration or C/D circulation-number application under 28(3)/29(1)(b); a name-only update of the same owner is different. The local declarant/registrant must be eligible under Article 25 and hold the applicable owner authorisation and warranty support. A different local importer or registrant is separately recognised in the conditional priority process of32a; it is not an unrestricted transfer of the existing number.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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IVD labels and Vietnamese instructions

answers.ivd-label-language
Fact-level verified

An IVD circulating in Vietnam must meet Article22 label requirements and have Vietnamese instructions for use, with the stated warranty-information exceptions. Where IFU or warranty information is provided electronically rather than accompanying the device, the label must clearly show how to retrieve it. A brand, owner or REF change must be aligned with the actual label and current dossier; the language rule does not itself decide the filing route.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Current update forms and supporting evidence

answers.update-form-materials
Fact-level verified

Circular44/2025 Form 13(A/B) and Form 14(C/D) identify the existing number and show previously declared/issued information beside updated information, with related documents and a signed/stamped or digital-signature commitment. Update all affected dossier evidence consistently; these forms are not a transfer approval or a replacement for a new application when Article28(3) or29(1)(b) is triggered.

Văn bản hợp nhất số 08/VBHN-BYT hợp nhất Nghị định 98/2021/NĐ-CP quy định về quản lý thiết bị y tế

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Vietnam approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Vietnam (7 records)

VietnamUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

Yes

Benefit

A US clearance supplies the free sale certificate and the technical evidence the Vietnamese dossier is built on. Decree 98/2021 sets its periods per procedure and class, not by where the device was approved.

Timeline Savings

None published

Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/DVietnam MOH Department of Health Infrastructure and Equipment — published administrative procedures for new circulation numbers, stating the 45-day, 30-day and 1-working-day steps

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

VietnamASEAN

Prior approval / evidence record

ASEAN CSDT

Name

ASEAN CSDT

Description

Common Submission Dossier Template for ASEAN region

Timeline Reduction

20-30% faster

Eligibility
  • ASEAN member state registrations
Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/DVietnam MOH Department of Health Infrastructure and Equipment — published administrative procedures for new circulation numbers, stating the 45-day, 30-day and 1-working-day steps

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

VietnamNMPA

Prior approval / evidence record

China NMPA approval: reliance route

reliance.china-nmpa-reliance-route
Fact-level verified
Statement

Decree 98/2021/NĐ-CP (consolidated text 08/VBHN-BYT of 6 March 2026) names China's NMPA as one of the 'reference countries' (nước tham chiếu): a Class C/D device holding a Certificate of Free Sale or Market Authorization from a reference country qualifies for fast-track issuance of a circulation number under Art. 29(2)(a). The fast-track dossier (Art. 30(3)) consists of the application, legal documents, the reference-country marketing document, a Vietnamese IVD quality certificate where applicable, and the CSDT; the Ministry of Health assesses only the legal documents and must issue the circulation number within 10 working days of a complete dossier (Art. 32(3)(a)). Other reference countries are US FDA, Australia TGA, Health Canada, Japan MHLW/PMDA, EU member states, UK, Switzerland and Korea MFDS.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

Valid Certificate of Free Sale or Market Authorization from China NMPA, as the named reference authority

Target Jurisdiction Id

vietnam

China Classes In Scope

Products holding the qualifying reference-authority document and independently classified as Vietnam Class C or D; do not assume Chinese risk classes map to Vietnam

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Device must hold a CFS or Market Authorization issued by a reference country (NMPA listed) or by an organisation on the list recognised by Vietnam's competent authority
  • Applies to Class C/D registration (Mục 3, Chương IV); Class A/B follow công bố tiêu chuẩn áp dụng
  • Dossier per Art. 30(3): application, documents under Art. 30(1)(b)-(d), reference-country marketing document, Vietnamese quality-assessment certificate for IVDs unless exempt, CSDT
  • MOH reviews legal documents only; 10 working days from complete, valid dossier including fee receipt (Art. 32(3)(a))
  • Imported devices must also supply the import licence/circulation evidence where Art. 29(2)(b) is relied upon
  • The 10-working-day clock is the complete, valid application review clock, not an end-to-end project duration or a guarantee for an incomplete application.

Effective from 2022-01-01

Source passage: 2. Cấp nhanh số lưu hành mới đối với thiết bị y tế thuộc một trong các trường hợp sau đây: a) Đã được một trong các tổ chức hoặc nước sau cấp giấy chứng nhận lưu hành tự do (Certificate of Free Sale) hoặc giấy chứng nhận lưu hành (Market Authorization) (sau đây viết tắt là giấy lưu hành): Cục Quản lý Thực phẩm và Dược phẩm Hoa Kỳ (FDA) - Mỹ; Cục Quản lý hàng hóa trị liệu (TGA) - Úc; Cơ quan quản lý y tế Canada (Health Canada); Bộ Y tế, Lao động và Phúc lợi Nhật Bản (MHLW) hoặc Cơ quan Dược phẩm và Thiết bị y tế (PMDA) - Nhật Bản, các nước thành viên EU, Anh, Thụy Sỹ; Cục Quản lý sản phẩm y tế quốc gia cấp trung ương (National Medical Products Administration - NMPA) - Trung Quốc; Bộ An toàn thực phẩm và dược phẩm (Ministry of Food & Drug Safety - MFDS) - Hàn Quốc hoặc thuộc danh sách các tổ chức cấp giấy lưu hành được cơ quan có thẩm quyền của Việt Nam công nhận (sau đây viết tắt là nước tham chiếu);

VietnamNMPA · US FDA · EU conformity assessment · Australia TGA · Japan MHLW / PMDA · UK MHRA · Swissmedic · South Korea MFDS

Prior approval / evidence record

Class C

Id

class-c

Class Name

Class C

Risk Level

high

Pathway

Circulation number registration (Ministry of Health)

Official Timeline
Min

45

Max

45

Unit

days

Verification Status

official-verified

Official Source
Title

Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D

Url

https://vanban.chinhphu.vn/?pageid=27160&docid=204442

Effective Date

2022-01-01

Accessed Date

2026-08-29

Realistic Timeline
Min

4

Max

5

Unit

months

With Prior Approval
Min

10

Max

10

Unit

working-days

Prior Approval Benefits
  • FDA
  • TGA
  • MHLW
  • EU
  • MHRA
  • Swissmedic
  • NMPA
  • MFDS
Notes
  • Decree 98/2021 Art. 32(5): the Minister of Health must appraise and grant the circulation number within 45 days of a complete and valid dossier, counted only once the appraisal fee receipt is in, and must issue any request for supplementation within 40 days
  • Art. 32(2) shortens this to 30 days, with a 25-day supplementation notice, where a corresponding national technical regulation (QCVN) exists for the device, and the same 30 days applies to measuring instruments that need pattern approval
  • Art. 32(3): the fast track for devices already authorised in a reference country, or previously import-licensed, is decided in 10 working days with a 10-working-day supplementation notice — here the Ministry appraises only the legal documents and verifies the rest after the number is granted
  • Art. 32(4): the emergency route is also 10 working days, with an 8-working-day supplementation notice
  • The clock does not simply run out in the applicant favour: if the dossier is not corrected within 90 days of a request, or fails after five rounds of supplementation, the procedure restarts from the beginning
  • Art. 32(6): the granted number and the dossier are published on the medical device portal within 1 working day
Clinical Trial Required

No

Local Testing Required

No

Gmp Required

Yes

Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

VietnamASEAN

Prior approval / evidence record

ASEAN MRA

Authority

ASEAN MRA

Accepted

Yes

Benefit

Harmonized pathway

Timeline Savings

2-3 months

Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/DVietnam MOH Department of Health Infrastructure and Equipment — published administrative procedures for new circulation numbers, stating the 45-day, 30-day and 1-working-day steps

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

VietnamEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority

EU CE Mark

Accepted

Yes

Benefit

Serves the same role as a US clearance in the dossier, with no recognition route and no published reduction.

Timeline Savings

None published

Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/DVietnam MOH Department of Health Infrastructure and Equipment — published administrative procedures for new circulation numbers, stating the 45-day, 30-day and 1-working-day steps

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

VietnamNMPA · US FDA · EU conformity assessment · Australia TGA · Japan MHLW / PMDA · UK MHRA · Swissmedic · South Korea MFDS

Prior approval / evidence record

Class D

Id

class-d

Class Name

Class D

Risk Level

highest

Pathway

Circulation number registration (Ministry of Health)

Official Timeline
Min

45

Max

45

Unit

days

Verification Status

official-verified

Official Source
Title

Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D

Url

https://vanban.chinhphu.vn/?pageid=27160&docid=204442

Effective Date

2022-01-01

Accessed Date

2026-08-29

Realistic Timeline
Min

4

Max

5

Unit

months

With Prior Approval
Min

10

Max

10

Unit

working-days

Prior Approval Benefits
  • FDA
  • TGA
  • MHLW
  • EU
  • MHRA
  • Swissmedic
  • NMPA
  • MFDS
Notes
  • Decree 98/2021 Art. 32(5): the Minister of Health must appraise and grant the circulation number within 45 days of a complete and valid dossier, counted only once the appraisal fee receipt is in, and must issue any request for supplementation within 40 days
  • Art. 32(2) shortens this to 30 days, with a 25-day supplementation notice, where a corresponding national technical regulation (QCVN) exists for the device, and the same 30 days applies to measuring instruments that need pattern approval
  • Art. 32(3): the fast track for devices already authorised in a reference country, or previously import-licensed, is decided in 10 working days with a 10-working-day supplementation notice — here the Ministry appraises only the legal documents and verifies the rest after the number is granted
  • Art. 32(4): the emergency route is also 10 working days, with an 8-working-day supplementation notice
  • The clock does not simply run out in the applicant favour: if the dossier is not corrected within 90 days of a request, or fails after five rounds of supplementation, the procedure restarts from the beginning
  • Art. 32(6): the granted number and the dossier are published on the medical device portal within 1 working day
Clinical Trial Required

Yes

Local Testing Required

No

Gmp Required

Yes

Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

C/D clocks only after a new-route trigger

answers.new-route-review-clocks
Fact-level verified

Where the change requires a new C/D application, Article 32 distinguishes30 calendar days for the specified Article 30(1)-(2) routes, ten working days for the fast and emergency routes, and45 calendar days for the other-device route, from a complete valid dossier including fee evidence if no amendment is requested. Deficiency-notice periods and90-day applicant-response/repeated-amendment limits are separate. None of these clocks is a review period for a five/ten-day change notification.

Conditions
  • Select the actual new-application category and its complete-dossier conditions.
  • A priority-request decision within ten working days is not a circulation-number grant.

Related structured datasets

Classification systems · 1 record
Open Risk classes A through D. →
Id

vietnam:medical-device

Jurisdiction Id

vietnam

Domains
  • medical-device
  • ivd
Name

Risk classes A through D.

Classes
  • Id

    a

    Label

    Class A

    Normalized Risk Level

    low

  • Id

    b

    Label

    Class B

    Normalized Risk Level

    medium

  • Id

    c

    Label

    Class C

    Normalized Risk Level

    high

  • Id

    d

    Label

    Class D

    Normalized Risk Level

    highest

Regulator

Ministry of Health

Official Domains
  • moh.gov.vn
  • dav.gov.vn
Source Status

official-source-verified

Source Title

Decree 98/2021/NĐ-CP (consolidated text), Arts. 4-9 and Annexes I-IV

Source Url

https://imda.moh.gov.vn/documents/10182/10030594/VB05_NDQLTBYT/aa35210b-dd78-489e-a843-8545b0b17926

Verified On

2026-08-25

Source Supports
  • class-axis
  • classification-rules
  • ivd-class-axis
  • ivd-classification-rules
Notes
  • Art. 5(4): the product owner self-classifies under the rules in Annexes I-IV; Art. 5(2)-(3): where one device falls under several risk levels the highest applies; Art. 5(5): MOH-issued class lists (Arts. 6-9) prevail where they differ from the annex rules.
Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Vietnam registration →
Country

Vietnam

Jurisdiction Id

vietnam

Country Code

VN

Flag

🇻🇳

Regulator

Ministry of Health - Department of Medical Equipment and Health Works

Regulator Abbrev

Ministry of Health

Region

asia-pacific

Tier

2

Risk Classification

4-class (A, B, C, D)

Classes
  • Id

    class-a

    Class Name

    Class A

    Risk Level

    low

    Pathway

    Declaration of applied standards (provincial Department of Health)

    Official Timeline
    Min

    0

    Max

    0

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D

    Url

    https://vanban.chinhphu.vn/?pageid=27160&docid=204442

    Effective Date

    2022-01-01

    Accessed Date

    2026-08-29

    Realistic Timeline
    Min

    1

    Max

    2

    Unit

    weeks

    Notes
    • Decree 98/2021 Art. 28(2): once the provincial Department of Health receives the declaration dossier together with proof of fee payment, it publishes the declaration number on the medical device portal. No appraisal period is prescribed because no appraisal takes place — the number is issued on receipt and the declarant carries responsibility for the file.
    • Decree 148/2025/NĐ-CP moved the Class A and B declaration to the provincial level, so the filing goes to the Department of Health where the business is based rather than to the Ministry
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    class-b

    Class Name

    Class B

    Risk Level

    medium

    Pathway

    Declaration of applied standards (provincial Department of Health)

    Official Timeline
    Min

    0

    Max

    0

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D

    Url

    https://vanban.chinhphu.vn/?pageid=27160&docid=204442

    Effective Date

    2022-01-01

    Accessed Date

    2026-08-29

    Realistic Timeline
    Min

    1

    Max

    2

    Unit

    weeks

    Notes
    • Decree 98/2021 Art. 28(2): once the provincial Department of Health receives the declaration dossier together with proof of fee payment, it publishes the declaration number on the medical device portal. No appraisal period is prescribed because no appraisal takes place — the number is issued on receipt and the declarant carries responsibility for the file.
    • Changes of owner, type, model, intended use or indication, and additions of a manufacturing site or product code, require the declaration to be made again rather than amended
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    class-c

    Class Name

    Class C

    Risk Level

    high

    Pathway

    Circulation number registration (Ministry of Health)

    Official Timeline
    Min

    45

    Max

    45

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D

    Url

    https://vanban.chinhphu.vn/?pageid=27160&docid=204442

    Effective Date

    2022-01-01

    Accessed Date

    2026-08-29

    Realistic Timeline
    Min

    4

    Max

    5

    Unit

    months

    With Prior Approval
    Min

    10

    Max

    10

    Unit

    working-days

    Prior Approval Benefits
    • FDA
    • TGA
    • MHLW
    • EU
    • MHRA
    • Swissmedic
    • NMPA
    • MFDS
    Notes
    • Decree 98/2021 Art. 32(5): the Minister of Health must appraise and grant the circulation number within 45 days of a complete and valid dossier, counted only once the appraisal fee receipt is in, and must issue any request for supplementation within 40 days
    • Art. 32(2) shortens this to 30 days, with a 25-day supplementation notice, where a corresponding national technical regulation (QCVN) exists for the device, and the same 30 days applies to measuring instruments that need pattern approval
    • Art. 32(3): the fast track for devices already authorised in a reference country, or previously import-licensed, is decided in 10 working days with a 10-working-day supplementation notice — here the Ministry appraises only the legal documents and verifies the rest after the number is granted
    • Art. 32(4): the emergency route is also 10 working days, with an 8-working-day supplementation notice
    • The clock does not simply run out in the applicant favour: if the dossier is not corrected within 90 days of a request, or fails after five rounds of supplementation, the procedure restarts from the beginning
    • Art. 32(6): the granted number and the dossier are published on the medical device portal within 1 working day
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    class-d

    Class Name

    Class D

    Risk Level

    highest

    Pathway

    Circulation number registration (Ministry of Health)

    Official Timeline
    Min

    45

    Max

    45

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D

    Url

    https://vanban.chinhphu.vn/?pageid=27160&docid=204442

    Effective Date

    2022-01-01

    Accessed Date

    2026-08-29

    Realistic Timeline
    Min

    4

    Max

    5

    Unit

    months

    With Prior Approval
    Min

    10

    Max

    10

    Unit

    working-days

    Prior Approval Benefits
    • FDA
    • TGA
    • MHLW
    • EU
    • MHRA
    • Swissmedic
    • NMPA
    • MFDS
    Notes
    • Decree 98/2021 Art. 32(5): the Minister of Health must appraise and grant the circulation number within 45 days of a complete and valid dossier, counted only once the appraisal fee receipt is in, and must issue any request for supplementation within 40 days
    • Art. 32(2) shortens this to 30 days, with a 25-day supplementation notice, where a corresponding national technical regulation (QCVN) exists for the device, and the same 30 days applies to measuring instruments that need pattern approval
    • Art. 32(3): the fast track for devices already authorised in a reference country, or previously import-licensed, is decided in 10 working days with a 10-working-day supplementation notice — here the Ministry appraises only the legal documents and verifies the rest after the number is granted
    • Art. 32(4): the emergency route is also 10 working days, with an 8-working-day supplementation notice
    • The clock does not simply run out in the applicant favour: if the dossier is not corrected within 90 days of a request, or fails after five rounds of supplementation, the procedure restarts from the beginning
    • Art. 32(6): the granted number and the dossier are published on the medical device portal within 1 working day
    Clinical Trial Required

    Yes

    Local Testing Required

    No

    Gmp Required

    Yes

Expedited Pathways
  • Name

    ASEAN CSDT

    Description

    Common Submission Dossier Template for ASEAN region

    Timeline Reduction

    20-30% faster

    Eligibility
    • ASEAN member state registrations
Prior Approvals
  • Authority

    FDA 510(k)/PMA

    Accepted

    Yes

    Benefit

    A US clearance supplies the free sale certificate and the technical evidence the Vietnamese dossier is built on. Decree 98/2021 sets its periods per procedure and class, not by where the device was approved.

    Timeline Savings

    None published

  • Authority

    EU CE Mark

    Accepted

    Yes

    Benefit

    Serves the same role as a US clearance in the dossier, with no recognition route and no published reduction.

    Timeline Savings

    None published

  • Authority

    ASEAN MRA

    Accepted

    Yes

    Benefit

    Harmonized pathway

    Timeline Savings

    2-3 months

Key Requirements
  • Vietnam Local Agent
  • Vietnamese labeling
  • ISO 13485 certification
  • Free Sale Certificate
  • Technical documentation
  • Issue-then-verify applies only to the fast-track and emergency routes in Art. 32(3) and 32(4) of Decree 98/2021, where the Ministry appraises the legal documents and checks the remainder after granting; the ordinary Class C/D route in Art. 32(2) and 32(5) is still a full front-loaded appraisal
  • Circular 44/2025/TT-BYT (22 Nov 2025) only delegates the Ministry's Class C/D tasks to the Department of Health Infrastructure and Equipment; it changes who decides, not how long they have
  • Clinical investigations: the Ministry checks dossier validity within 5 working days and forwards a valid dossier to the National Ethics Committee within 2 working days, which then meets and minutes its appraisal within 25 days (Decree 98/2021 Arts. 16-18)
  • Import licence for devices without a circulation number: 15 working days, cut to 2 working days for urgent epidemic-response needs (Art. 48)
  • Changes to a granted circulation number must be notified and the published dossier updated within 10 working days; for a Class A/B declaration the window is 5 working days
Local Rep Required

Yes

Local Rep Name

Vietnam Local Agent

Mdsap Accepted

No

Mdsap Benefit

Not accepted but ISO 13485 required

Registration Validity

5 years

Last Updated

2026-08-29

Verification Status

official-verified

Official Sources
  • Title

    Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D

    Url

    https://vanban.chinhphu.vn/?pageid=27160&docid=204442

    Effective Date

    2022-01-01

    Accessed Date

    2026-08-29

  • Title

    Vietnam MOH Department of Health Infrastructure and Equipment — published administrative procedures for new circulation numbers, stating the 45-day, 30-day and 1-working-day steps

    Url

    https://imda.moh.gov.vn/dich-vu-cong

    Accessed Date

    2026-08-29

Reviewed On

2026-08-29

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Vietnam Local Agent.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    Ministry of Health reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. Ministry of Health may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, Ministry of Health issues Vietnam market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Vietnam fees →
Jurisdiction Id

vietnam

Country

Vietnam

Country Code

VN

Authority

Ministry of Health / IMDA

Low Risk Local
Min

500000

Max

1500000

Currency

VND

Per Product

Yes

High Risk Local
Min

3000000

Max

3000000

Currency

VND

Per Product

Yes

Details
  • Id

    class-a-standard-declaration

    Item

    Class A standards declaration

    Currency

    VND

    Amount Local

    500000

    Amount Local Formatted

    VND 500,000

    Frequency

    Per dossier

    Notes

    Current amount is 50% of the VND 1,000,000 base fee in Circular 59/2023.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://congbao.chinhphu.vn/van-ban/thong-tu-so-64-2025-tt-btc-45348/57287.htm

    Source Title

    Vietnam Ministry of Finance Circular 64/2025/TT-BTC: temporary 50% healthcare-fee reduction

    Source Effective Date

    2025-07-01

    Verified On

    2026-08-25

  • Id

    class-b-standard-declaration

    Item

    Class B standards declaration

    Currency

    VND

    Amount Local

    1500000

    Amount Local Formatted

    VND 1,500,000

    Frequency

    Per dossier

    Notes

    Current amount is 50% of the VND 3,000,000 base fee in Circular 59/2023.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://congbao.chinhphu.vn/van-ban/thong-tu-so-64-2025-tt-btc-45348/57287.htm

    Source Title

    Vietnam Ministry of Finance Circular 64/2025/TT-BTC: temporary 50% healthcare-fee reduction

    Source Effective Date

    2025-07-01

    Verified On

    2026-08-25

  • Id

    class-c-d-circulation-number

    Item

    Class C/D circulation-number application

    Currency

    VND

    Amount Local

    3000000

    Amount Local Formatted

    VND 3,000,000

    Frequency

    Per dossier

    Notes

    Current amount is 50% of the VND 6,000,000 base fee in Circular 59/2023.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://congbao.chinhphu.vn/van-ban/thong-tu-so-64-2025-tt-btc-45348/57287.htm

    Source Title

    Vietnam Ministry of Finance Circular 64/2025/TT-BTC: temporary 50% healthcare-fee reduction

    Source Effective Date

    2025-07-01

    Verified On

    2026-08-25

Notes
  • Circular 59/2023 sets base fees of VND 1,000,000 for Class A, VND 3,000,000 for Class B, and VND 6,000,000 for Class C/D.
  • Circular 64/2025 reduces every healthcare-sector fee under Circular 59/2023 by 50% from 1 July 2025 through 31 December 2026; the table shows these currently payable reduced amounts.
  • Unless a later instrument extends or replaces the reduction, the base amounts resume on 1 January 2027.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    Vietnam Ministry of Finance Circular 64/2025/TT-BTC: temporary 50% healthcare-fee reduction

    Url

    https://congbao.chinhphu.vn/van-ban/thong-tu-so-64-2025-tt-btc-45348/57287.htm

    Effective Date

    2025-07-01

    Accessed Date

    2026-08-25

  • Title

    Vietnam Ministry of Finance Circular 59/2023/TT-BTC: healthcare fee schedule

    Url

    https://vanban.chinhphu.vn/?classid=1&docid=208609&orggroupid=4&pageid=27160

    Effective Date

    2023-10-16

    Accessed Date

    2026-08-25

  • Title

    Vietnam Ministry of Health medical-device procedures and base fees under Circular 59/2023

    Url

    https://moh.gov.vn/tin-lien-quan/-/asset_publisher/vjYyM7O9aWnX/content/bo-y-te-cong-bo-muc-thu-phi-mot-so-linh-vuc-kham-chua-benh-trang-thiet-bi-y-te

    Effective Date

    2023-10-16

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Vietnam certifications →
Slug

vietnam

Market

Vietnam

Confidence

low

Schemes
  • Id

    medical-electrical-evidence

    Name

    Medical electrical evidence

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Decree 98/2021/NĐ-CP (VBHN 08/VBHN-BYT) provides the applied-standards declaration (công bố tiêu chuẩn áp dụng) route for Class A/B devices (Điều 21), with circulation conditions in Điều 23 and exceptions in Điều 24; Class C/D evidence forms part of the registration dossier (corpus anchors sec-21/sec-23/sec-24 of vn-decree-98-vietnamese). These medical-registration provisions do not establish a general exemption from separate product-specific electrical-safety requirements; verify the applicable product and component catalogues for the proposed device.

    Source Binding

    unresolved

  • Id

    moh-import-licence

    Name

    MOH medical device import licence

    Category

    Import Conformity

    Status

    Mandatory If Feature

    Object

    Specific Circumstance Imports

    Note

    Giấy phép nhập khẩu thiết bị y tế: required only for the enumerated cases in Điều 48(1) of Decree 98/2021/NĐ-CP (VBHN 08/VBHN-BYT) — unregistered devices imported for research, testing, evaluation or training (a); urgent epidemic/disaster response (b); aid, humanitarian gifts, exhibitions (c); humanitarian medical treatment (đ); individual-treatment devices (d); and ODA-funded facility procurement (e) — per Điều 46(3) the licence is needed only for these imports while devices already holding a circulation number are imported without MOH approval (corpus anchors sec-46/sec-48 of vn-decree-98-vietnamese). Dossier per Điều 48(2) includes Vietnamese technical description and manufacturer QMS certificate.

    Source Urls
    • https://datafiles.chinhphu.vn/cpp/files/vbpq/2026/3/08-vbhn-byt.pdf
    Source Binding

    reviewed

  • Id

    mic-type-approval-certification-and-declaration-of-conformity

    Name

    MOST/MIC ICT conformity certification and declaration

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Product In Current Mandatory Catalogue

    Note

    MOST Circular 36/2026/TT-BKHCN, signed 30 June 2026 and effective 1 July 2026, replaces Circular 29/2025/TT-BKHCN and the former MIC certification/declaration procedure Circular 30/2011/TT-BTTTT and its amendments. Its high/medium-risk catalogues prescribe product-specific conformity procedures and technical regulations. Apply the exact product description, HS scope, frequency/power thresholds and exceptions to each device or module. For example, the short-range-radio exclusion in Annex II note (3) includes Bluetooth and Zigbee below 60 mW EIRP; Wi-Fi/BLE/cellular functionality alone does not establish coverage. Articles 3–4 require appropriately accredited, designated or legally recognized testing organizations for the applicable conformity route. Relevant evidence locators: Articles 3–6, Annex II ICT rows and note (3) (Gazette p. 113).

    Source Urls
    • https://congbao.chinhphu.vn/van-ban/thong-tu-so-36-2026-tt-bkhcn-469968.htm
    Source Binding

    reviewed

  • Id

    cr-marking

    Name

    CR marking

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Covered Product

    Note

    CR conformity marking continues under the risk-based product-quality framework: Law on Product Quality 05/2007/QH12 as amended by Law 78/2025/QH15, implemented by Decree 37/2026/NĐ-CP (2026-01-23), with the medium/high-risk catalogue now in Thông tư 36/2026/TT-BKHCN (effective 2026-07-01), which repealed the former MIC certification/declaration procedure Circular 30/2011/TT-BTTTT.

    Source Urls
    • https://congbao.chinhphu.vn/van-ban/thong-tu-so-36-2026-tt-bkhcn-469968.htm
    Source Binding

    candidate

  • Id

    varans-radiation-import-use-licence

    Name

    VARANS radiation import/use licence

    Category

    Ionizing Radiation

    Status

    Mandatory If Feature

    Object

    Radiation Product Or Use Site

    Note

    Decree 332/2025/NĐ-CP implements Atomic Energy Law 94/2025/QH15 and replaced Decree 142/2020/NĐ-CP from 1 January 2026 (Điều 107). Điều 22 requires radiation-work licences subject to its specific exemptions; Điều 24 sets conditions for use of medical diagnostic X-ray equipment. The transition in Điều 106(3) preserves existing QCVNs on radiation safety, source grouping and notification/licensing exemptions, together with QCVNs for radiotherapy accelerators and medical X-ray equipment, until replacement. This is not a blanket exemption for those devices. Circular 36/2026/TT-BKHCN separately lists medical diagnostic X-ray equipment (HS 9022.14.00, QCVN 5:2010/BKHCN and 11:2015/BKHCN) and radiotherapy accelerators (including QCVN 13:2017/BKHCN), routing them to atomic-energy-law management rather than the product-quality conformity procedures.

    Source Urls
    • https://congbao.chinhphu.vn/van-ban/nghi-dinh-so-332-2025-nd-cp-467901.htm
    • https://congbao.chinhphu.vn/van-ban/thong-tu-so-36-2026-tt-bkhcn-469968.htm
    Source Binding

    reviewed

  • Id

    environmental-epr

    Name

    Environmental EPR

    Category

    Environmental And Batteries

    Status

    Mandatory If Feature

    Object

    Covered Producer Or Product

    Note

    Producer/importer extended-responsibility duties (recycling of listed products and packaging, waste processing) under the Law on Environmental Protection 2020 as detailed by Decree 08/2022/NĐ-CP and its EPR amendments, with Decree 110/2026/NĐ-CP issued 2026 on producers' and importers' recycling and waste-processing responsibility (trách nhiệm tái chế sản phẩm, bao bì và trách nhiệm xử lý chất thải của nhà sản xuất, nhập khẩu) on the Government Portal. Applies only to devices/packaging on the covered catalogues.

    Source Urls
    • https://vanban.chinhphu.vn?pageid=27160&docid=217544&orggroupid=2
    Source Binding

    candidate

  • Id

    imda-verification-of-in-use-devices

    Name

    IMDA verification of in-use devices

    Category

    Legal Metrology

    Status

    Mandatory For Use Site

    Object

    In Service Medical Equipment

    Note

    Kiểm định (statutory verification) regime: IMDA registers and withdraws verification-facility operation certificates (Art. 56 Decree 98/2021/NĐ-CP) and decides the disposition of devices failing verification (Art. 58) per Circular 44/2025/TT-BYT Art. 2 items 9-10; measuring-inspection devices are also subject to specialized inspection under Decree 217/2025/NĐ-CP (item 11).

    Source Urls
    • https://imda.moh.gov.vn/documents/10182/10030594/TT44.2025/49f088be-1134-46fb-a3c1-81de8a1f2215
    Source Binding

    reviewed

Official Sources
  • Authority

    MOST (Bộ Khoa học và Công nghệ)

    Topic

    Circular 36/2026/TT-BKHCN medium/high-risk product catalogue — ICT radio equipment conformity + radiation/nuclear devices routed to atomic-energy law (replaces TT 29/2025/TT-BKHCN and TT 30/2011/TT-BTTTT, effective 2026-07-01)

    Url

    https://congbao.chinhphu.vn/van-ban/thong-tu-so-36-2026-tt-bkhcn-469968.htm

  • Authority

    Government of Vietnam / Ministry of Health

    Topic

    Decree 98/2021/NĐ-CP consolidation VBHN 08/VBHN-BYT — applied-standards declaration (Điều 21/23/24) and import licence (Điều 46/48)

    Url

    https://datafiles.chinhphu.vn/cpp/files/vbpq/2026/3/08-vbhn-byt.pdf

  • Authority

    Government of Vietnam / VARANS (MOST)

    Topic

    Decree 332/2025/NĐ-CP radiation-safety licensing under Atomic Energy Law 94/2025/QH15 (replaces Decree 142/2020/NĐ-CP, effective 2026-01-01)

    Url

    https://congbao.chinhphu.vn/van-ban/nghi-dinh-so-332-2025-nd-cp-467901.htm

  • Authority

    Government of Vietnam

    Topic

    Decree 110/2026/NĐ-CP producer/importer recycling and waste-processing responsibility (EPR)

    Url

    https://vanban.chinhphu.vn?pageid=27160&docid=217544&orggroupid=2

  • Authority

    IMDA

    Topic

    Circular 44/2025/TT-BYT verification facility certificates and failing-device disposition

    Url

    https://imda.moh.gov.vn/documents/10182/10030594/TT44.2025/49f088be-1134-46fb-a3c1-81de8a1f2215

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