Explore the medical device requirements currently available for Vietnam, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
Device advertising operates via public disclosure (công khai) of intended advertising content and form using form Mẫu 16, filed by the circulation-number owner or its written authorized organization, committing that ad content matches the disclosed version and the A/B declaration or C/D registration dossier.
Effective from 2025-11-22
Circular 09/2015/TT-BYT (25/05/2015) established the prior confirmation regime (xác nhận nội dung quảng cáo) for special products under MOH; current device advertising uses the disclosure mechanism of Circular 44/2025.
What expires, what is retained periodically, and when must renewal start?
Class C/D circulation numbers are issued without expiry (indefinite, subject to ongoing compliance); import licences under the pre-2025 regime were extended only to 31/12/2024.
For Class C/D devices, the owner submits a commitment-and-request for continued circulation (Phụ lục IV Mẫu 01) and IMDA issues a written continuation decision (Mẫu 02); these decisions are decentralized to IMDA under Art. 2 item 5 of Circular 44/2025.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Dossier-information changes are handled by notification on dedicated forms: Mẫu 12 (production-conditions dossier), Mẫu 13 (Class A/B declaration dossier), Mẫu 14 (Class C/D registration dossier) — confirming notification-type change-control outcomes.
Which clinical or IVD performance evidence or study is required and accepted?
Clinical investigations of medical devices operate under an MOH approval regime: dossiers for approval and for amendments to approved trials (phê duyệt thay đổi thử nghiệm lâm sàng) are prescribed; scope/timelines not extracted.
Is the product a device, IVD, accessory, software, or borderline product locally?
An accessory is a product designated by the device owner for a specific purpose together with a specific medical device, to enable or support that device's use for its intended purpose.
'Product owner' (Chủ sở hữu thiết bị y tế) is the organization or individual that supplies the device under its own name/trade name and is responsible for design, manufacture, assembly, processing, packaging, repair, or determining the intended use.
Which evidence, local deltas, formats, and signatures are required?
The contents of the Class A/B declaration-of-applied-standard dossier are specified in a dedicated article (Art. 24) of Decree 98.
Circular 44/2025 prescribes standard templates for the power of attorney (Phụ lục V), warranty-capability certificate (Phụ lục VI), device technical documentation (Phụ lục VII) and export/import/inventory/use reporting (Phụ lục VIII); POAs and warranty certificates issued under TT 19/2021 (as amended by TT 10/2023) remain accepted.
Effective from 2025-11-22
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Regulatory acts (e.g., advertising disclosure) are performed by the circulation-number owner or an organization holding its written authorization; a standard power-of-attorney form (Mẫu giấy ủy quyền, Phụ lục V) and warranty-capability certificate (Phụ lục VI, signed by the owner) are prescribed.
Which establishment licences, importer permissions, and distribution controls apply?
IMDA issues medical-device import licences under Art. 48 of Decree 98 (as amended); the application uses form Mẫu 10 of Circular 44/2025.
Effective from 2025-11-22
A Class C/D circulation number is the legal basis for verification registration, import, export and circulation of the device in Vietnam.
MOH does not issue import licences for used medical devices; import licences valid under the pre-2025 framework were extended only to 31/12/2024.
· Effective until 2024-12-31
What regulator fee applies to this class, route, event, and date?
Health-sector fees, including medical-device dossier fees under the TT 59/2023/TT-BTC schedule, are collected at 50% from 01/07/2025 to 31/12/2026; full rates apply again from 01/01/2027.
Effective from 2025-07-01 · Effective until 2026-12-31
Which label and IFU elements, languages, symbols, and translation controls apply?
Where the Vietnamese instructions for use and the warranty information do not accompany the device, they must be supplied in electronic form, and the device label must clearly show how to look up that information.
Original passage: 'Trường hợp thông tin theo quy định tại các điểm c và d khoản 1 Điều này không kèm theo thiết bị y tế thì phải cung cấp dưới hình thức thông tin điện tử và phải thể hiện rõ hướng dẫn tra cứu thông tin trên nhãn thiết bị y tế'. Anchor: /data/regulations/vietnam/vn-decree-98-vietnamese.vi.html#sec-22.
A medical device may only circulate on the Vietnamese market if it has a label carrying the complete information required by the current goods-labelling legislation and is supplied with instructions for use for the medical device in Vietnamese, together with warranty-service, warranty-condition and warranty-period information where the exceptions in Art. 22(1)(d) and 22(2) do not apply.
Original passages: 'b) Có nhãn với đầy đủ các thông tin theo quy định hiện hành của pháp luật về nhãn hàng hóa; c) Có hướng dẫn sử dụng của thiết bị y tế bằng tiếng Việt; d) Có thông tin về cơ sở bảo hành, điều kiện và thời gian bảo hành'. Anchor: /data/regulations/vietnam/vn-decree-98-vietnamese.vi.html#sec-22 (consolidation PDF re-fetched 2026-09-07, SHA-256 ede593a3…926188 byte-identical).
Warranty-service, warranty-condition and warranty-period information is not required for single-use devices so designated by the product owner, or for devices with documentation showing they carry no warranty scheme; devices holding an import licence under Art. 48(1)(a)-(đ) are also exempt from the warranty-information condition.
Original passages: 'trừ trường hợp thiết bị y tế sử dụng một lần theo quy định của chủ sở hữu thiết bị y tế hoặc có tài liệu chứng minh không có chế độ bảo hành' and 'Trường hợp có giấy phép nhập khẩu theo quy định tại các điểm a, b, c, d và đ khoản 1 Điều 48 Nghị định này không phải đáp ứng điều kiện quy định tại điểm d khoản 1 Điều này'. Anchor: /data/regulations/vietnam/vn-decree-98-vietnamese.vi.html#sec-22.
Which current law, regulation, guidance, and transition provisions apply?
Decree 98/2021/NĐ-CP is in force as amended by Decree 07/2023/NĐ-CP, Decree 96/2023/NĐ-CP and Decree 04/2025/NĐ-CP (consolidated scan published on IMDA's official library).
Decree 98/2021/NĐ-CP on medical device management was issued 08/11/2021 and took effect 01/01/2022.
Effective from 2022-01-01
Circular 44/2025/TT-BYT takes effect 22/11/2025 and repeals Circular 19/2021/TT-BYT (16/11/2021) on administrative-document templates for Decree 98.
Effective from 2025-11-22
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
A statutory reporting template exists for export, import, inventory and use of devices (and manufacturing materials/external-check substances containing narcotics or precursors), directed to health authorities.
Which current form, portal, account, and submission package must be used?
Current administrative forms are Mẫu 01-16 of Circular 44/2025: 01 production-conditions declaration; 02/03 Class A/B standard-application declaration; 04-08 Class C/D new applications (QCVN-based; measuring instruments; fast-track; urgent; other); 09 buy/sell conditions (B/C/D); 10 import licence; 11 free-sale certificate; 12-14 dossier update notifications; 16 advertising disclosure.
Effective from 2025-11-22
Which QMS, audit, inspection, and certificate scope is accepted or required?
Domestic manufacturing establishments must make a declaration of adequate production conditions (công bố đủ điều kiện sản xuất) using form Mẫu 01, with updates to the declared dossier notified on form Mẫu 12.
Which recall, FSCA, notice, and authority-coordination duties apply?
IMDA may suspend and terminate suspension of circulation of device batches (para 3 Art. 34) and order batch recalls (para 4 Art. 34) under Decree 98 as amended.
Effective from 2025-11-22
From Circular 44/2025, IMDA conducts specialized inspection (per para 1 Art. 6 Decree 217/2025/NĐ-CP) over organizations performing classification, manufacture, circulation, trading, export/import, services, information/advertising, and use of devices.
Effective from 2025-11-22
Which registration, notification, listing, reliance, or conformity route applies?
Dedicated application forms exist for fast-track (cấp nhanh, Mẫu 06) and urgent (cấp khẩn cấp, Mẫu 07) Class C/D circulation-number applications under Circular 44/2025.
Class C/D devices may only circulate in Vietnam with a circulation number (số lưu hành) issued by the competent authority; Class A/B devices circulate after declaration of the applied standard (công bố tiêu chuẩn áp dụng), except where exemption applies.
Which foreign decisions or evidence can be reused, with what effect and conditions?
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.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Prior approval / evidence record
FDA 510(k)/PMA
Yes
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.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
ASEAN CSDT
Common Submission Dossier Template for ASEAN region
20-30% faster
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
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.
china
nmpa
Valid Certificate of Free Sale or Market Authorization from China NMPA, as the named reference authority
vietnam
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
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
Yes
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);
Prior approval / evidence record
class-c
Class C
high
Circulation number registration (Ministry of Health)
45
45
days
official-verified
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
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
4
5
months
10
10
working-days
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
ASEAN MRA
Yes
Harmonized pathway
2-3 months
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
EU CE Mark
Yes
Serves the same role as a US clearance in the dossier, with no recognition route and no published reduction.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
Decree 98 contains a dedicated provision (Art. 36) on handling medical devices with foreign elements involving organizations such as the EU and ASEAN; full provision text not extracted.
Regulatory reference
Vietnam's MOH issued Decision 2426/QĐ-BYT (15/05/2021) adopting ASEAN guidance for preparing the common technical dossier for medical devices: harmonized dossier format only; national review and decision retained.
Prior approval / evidence record
class-d
Class D
highest
Circulation number registration (Ministry of Health)
45
45
days
official-verified
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
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
4
5
months
10
10
working-days
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
What review, validation, and applicant stop-clock rules apply?
Where no dossier amendments are requested, the Minister of Health must organise the assessment and grant the marketing number (số lưu hành) within 30 days of receiving a complete and valid dossier, including confirmation of payment of the assessment fee; where the dossier is not complete, MOH must notify the applicant of exactly which documents must be supplemented or corrected within 25 days of receiving the complete, valid dossier, and the applicant must then complete the amendments. If no number is granted, a written reasoned reply must be issued.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
For medical devices serving epidemic prevention and control, natural-disaster or catastrophe remediation in urgent cases on a list issued by the Ministry of Health, MOH grants a new emergency marketing number (cấp khẩn cấp số lưu hành) with a reduced dossier (application letter, a subset of the standard documents, and the free-sale or marketing authorisation certificate). Emergency marketing numbers are the exception to the general rule that marketing numbers are valid without time limit.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Decree 98 designates the authority competent to resolve Class C/D registration dossiers in a dedicated article (Art. 30); since 22/11/2025 this authority is IMDA.
Which UDI, device listing, database, and traceability duties apply?
Decree 98 makes traceability of medical devices (truy xuất nguồn gốc) one of the statutory management principles for devices.
What is reportable, by whom, where, in what format, and by what deadline?
On a warning from a competent Vietnamese or international authority about a latent risk that seriously threatens public health or could cause death, the marketing-number holder must inform the health facilities using the device and complete an investigation and determination of the risk within 30 days of receiving the warning, with a written report to MOH if more time is needed. Where an incident has already occurred that seriously threatens public health or causes death to users, the holder must publish a notice and notify the buyers, users and MOH, suspend circulation of the affected lot, investigate the cause, and report the investigation results to MOH.
vietnam:medical-device
vietnam
Risk classes A through D.
a
Class A
low
b
Class B
medium
c
Class C
high
d
Class D
highest
Ministry of Health
official-source-verified
Decree 98/2021/NĐ-CP (consolidated text), Arts. 4-9 and Annexes I-IV
https://imda.moh.gov.vn/documents/10182/10030594/VB05_NDQLTBYT/aa35210b-dd78-489e-a843-8545b0b17926
2026-08-25
Vietnam
vietnam
VN
🇻🇳
Ministry of Health - Department of Medical Equipment and Health Works
Ministry of Health
asia-pacific
2
4-class (A, B, C, D)
class-a
Class A
low
Declaration of applied standards (provincial Department of Health)
0
0
days
official-verified
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
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
1
2
weeks
No
No
No
class-b
Class B
medium
Declaration of applied standards (provincial Department of Health)
0
0
days
official-verified
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
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
1
2
weeks
No
No
Yes
class-c
Class C
high
Circulation number registration (Ministry of Health)
45
45
days
official-verified
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
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
4
5
months
10
10
working-days
No
No
Yes
class-d
Class D
highest
Circulation number registration (Ministry of Health)
45
45
days
official-verified
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
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
4
5
months
10
10
working-days
Yes
No
Yes
ASEAN CSDT
Common Submission Dossier Template for ASEAN region
20-30% faster
FDA 510(k)/PMA
Yes
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.
None published
EU CE Mark
Yes
Serves the same role as a US clearance in the dossier, with no recognition route and no published reduction.
None published
ASEAN MRA
Yes
Harmonized pathway
2-3 months
Yes
Vietnam Local Agent
No
Not accepted but ISO 13485 required
5 years
2026-08-29
official-verified
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
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
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
https://imda.moh.gov.vn/dich-vu-cong
2026-08-29
2026-08-29
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Vietnam Local Agent.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
Ministry of Health reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, Ministry of Health issues Vietnam market authorization certificate.
1-2 weeks
✅
vietnam
Vietnam
VN
Ministry of Health / IMDA
500000
1500000
VND
Yes
3000000
3000000
VND
Yes
class-a-standard-declaration
Class A standards declaration
VND
500000
VND 500,000
Per dossier
Current amount is 50% of the VND 1,000,000 base fee in Circular 59/2023.
exact-current
official-verified
https://congbao.chinhphu.vn/van-ban/thong-tu-so-64-2025-tt-btc-45348/57287.htm
Vietnam Ministry of Finance Circular 64/2025/TT-BTC: temporary 50% healthcare-fee reduction
2025-07-01
2026-08-25
class-b-standard-declaration
Class B standards declaration
VND
1500000
VND 1,500,000
Per dossier
Current amount is 50% of the VND 3,000,000 base fee in Circular 59/2023.
exact-current
official-verified
https://congbao.chinhphu.vn/van-ban/thong-tu-so-64-2025-tt-btc-45348/57287.htm
Vietnam Ministry of Finance Circular 64/2025/TT-BTC: temporary 50% healthcare-fee reduction
2025-07-01
2026-08-25
class-c-d-circulation-number
Class C/D circulation-number application
VND
3000000
VND 3,000,000
Per dossier
Current amount is 50% of the VND 6,000,000 base fee in Circular 59/2023.
exact-current
official-verified
https://congbao.chinhphu.vn/van-ban/thong-tu-so-64-2025-tt-btc-45348/57287.htm
Vietnam Ministry of Finance Circular 64/2025/TT-BTC: temporary 50% healthcare-fee reduction
2025-07-01
2026-08-25
2026-08-25
official-verified
Vietnam Ministry of Finance Circular 64/2025/TT-BTC: temporary 50% healthcare-fee reduction
https://congbao.chinhphu.vn/van-ban/thong-tu-so-64-2025-tt-btc-45348/57287.htm
2025-07-01
2026-08-25
Vietnam Ministry of Finance Circular 59/2023/TT-BTC: healthcare fee schedule
https://vanban.chinhphu.vn/?classid=1&docid=208609&orggroupid=4&pageid=27160
2023-10-16
2026-08-25
Vietnam Ministry of Health medical-device procedures and base fees under Circular 59/2023
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
2023-10-16
2026-08-25
2026-08-25
exact-current
Yes
vietnam
Vietnam
low
medical-electrical-evidence
Medical electrical evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
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.
unresolved
moh-import-licence
MOH medical device import licence
Import Conformity
Mandatory If Feature
Specific Circumstance Imports
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.
reviewed
mic-type-approval-certification-and-declaration-of-conformity
MOST/MIC ICT conformity certification and declaration
Radio Spectrum
Mandatory If Feature
Product In Current Mandatory Catalogue
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).
reviewed
cr-marking
CR marking
Radio Spectrum
Mandatory If Feature
Covered Product
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.
candidate
varans-radiation-import-use-licence
VARANS radiation import/use licence
Ionizing Radiation
Mandatory If Feature
Radiation Product Or Use Site
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.
reviewed
environmental-epr
Environmental EPR
Environmental And Batteries
Mandatory If Feature
Covered Producer Or Product
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.
candidate
imda-verification-of-in-use-devices
IMDA verification of in-use devices
Legal Metrology
Mandatory For Use Site
In Service Medical Equipment
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).
reviewed
MOST (Bộ Khoa học và Công nghệ)
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)
https://congbao.chinhphu.vn/van-ban/thong-tu-so-36-2026-tt-bkhcn-469968.htm
Government of Vietnam / Ministry of Health
Decree 98/2021/NĐ-CP consolidation VBHN 08/VBHN-BYT — applied-standards declaration (Điều 21/23/24) and import licence (Điều 46/48)
https://datafiles.chinhphu.vn/cpp/files/vbpq/2026/3/08-vbhn-byt.pdf
Government of Vietnam / VARANS (MOST)
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)
https://congbao.chinhphu.vn/van-ban/nghi-dinh-so-332-2025-nd-cp-467901.htm
Government of Vietnam
Decree 110/2026/NĐ-CP producer/importer recycling and waste-processing responsibility (EPR)
https://vanban.chinhphu.vn?pageid=27160&docid=217544&orggroupid=2
IMDA
Circular 44/2025/TT-BYT verification facility certificates and failing-device disposition
https://imda.moh.gov.vn/documents/10182/10030594/TT44.2025/49f088be-1134-46fb-a3c1-81de8a1f2215
