Medical Device Registration Process in Vietnam

Every medical device sold, imported, or used in Vietnam must be on file with the competent authority before circulation. Decree 98/2021/NĐ-CP runs a risk-stratified two-track system:

• Class A — Bản công bố tiêu chuẩn áp dụng (published declaration of applied standards). Filed at the provincial Sở Y tế where the importer or manufacturer is located. The lightest pathway; the published declaration takes effect on submission, with the Sở Y tế publishing the number on its register.
• Class B, C, D — Giấy chứng nhận đăng ký lưu hành (Marketing Authorisation Certificate, MAC; the registration is identified by a Số lưu hành). Filed at the Department of Medical Equipment and Construction (DMEC, Vụ Trang thiết bị y tế và Công trình y tế) at the Ministry of Health. Pre-market review against the ASEAN Common Submission Dossier Template (CSDT) and Decree 98 requirements, culminating in a Số lưu hành with 5-year validity.

An IVD and SaMD layer sits on top of this scheme — covered in detail at /medical-device/ivd-samd/. The risk classification taxonomy itself is covered at /medical-device/risk-classification/. This page is the operational/process page: how a dossier moves through the system, what timelines apply, and where the friction is.

Scope of this page:

• Step-by-step process for each track (Class A vs Class B/C/D).
• ASEAN CSDT modules and how they map onto the Vietnamese dossier.
• Reference-country (SRA) fast-track pathway under Decree 98 Article 30/31 — recognition of decisions from US-FDA, EMA, Japan PMDA, Australia TGA, Health Canada, Korea MFDS for eligible higher-class devices.
• Statutory timelines (typical: 10–15 working days for Class A, 60 working days for Class B/C/D MAC) vs the 2022–2024 backlog reality.
• The reform package: Decree 07/2023 emergency extension, Decree 96/2023 further transition, automatic extension of expiring MACs.
• Practical pitfalls — classification disputes, ATC (Authorised Trading Code) for importers, ISO 13485 recognition, Vietnamese-language labelling, and post-MAC change management.

How to read this page: "Key documents" lists the legal stack in consultation order. "Recent updates" walks the 2022–2024 backlog crisis and the two amending decrees chronologically. "Resources & links" gives the operational portals. The FAQ closes the most frequent sponsor questions.

Validity, renewal, and lifecycle:

• Số lưu hành is valid for 5 years from issue. Renewal is a fresh filing under Decree 98 Article 41.
• Decree 07/2023 introduced automatic extension for MACs in the registration backlog whose renewal dossiers were on file; this was further extended by Decree 96/2023 and absorbed into the operative regime.
• Material changes (manufacturer, indication, design, materials affecting safety) trigger re-registration under Decree 98 Article 33; minor changes are notified rather than re-registered.
• Class A declarations have no fixed validity — they remain in force while the underlying product specification and the declarant's ATC stay current.

Implementing decrees (Nghị định) — currently in force:

• Decree 98/2021/NĐ-CP — the foundational instrument for medical-device management in Vietnam; in force from 1 January 2022. Articles 22–32 govern Class B/C/D registration; Article 23 establishes the Class A published-declaration regime; Articles 30–31 set the reference-country fast track for devices already approved by an SRA.
• Decree 07/2023/NĐ-CP — first major amendment to Decree 98; in force from 3 March 2023. Emergency measure to resolve the 2022–2023 registration backlog: automatic extension of expiring MACs whose renewal dossiers were on file, deferred classification re-checks, and transitional acceptance of in-process Decree 36-era certificates.
• Decree 96/2023/NĐ-CP — second amendment; in force from 15 January 2024. Extended the Decree 07 transitional regime, tightened ATC and import-licence requirements, and rebalanced the inter-departmental responsibilities at MOH.

Implementing circulars:

• Circular 05/2022/TT-BYT — implementing details for classification, registration, recall, post-market vigilance; the operational rulebook companion to Decree 98.
• Circular 19/2021/TT-BYT — classification rules under the ASEAN Medical Device Directive (AMDD) framework; how the Class A/B/C/D taxonomy applies to specific device categories.
• Circular 10/2023/TT-BYT — list of medical devices in Group 2 subject to specific management measures; references specific QCVN technical regulations.

Historical context (cited in older registrations):

• Decree 36/2016/NĐ-CP — predecessor of Decree 98; cited in MAC certificates issued before 2022. Transitional rules under Decree 07/2023 and Decree 96/2023 made these registrations continue to be recognised through 31 December 2024 in defined cases.
• Circular 39/2016/TT-BYT — predecessor of Circular 05/2022; still cited in older variation documents.

Quality-system standards:

• ISO 13485:2016 — quality management system for medical devices; the QMS certificate must be referenced in the dossier. Vietnam accepts ISO 13485 certificates issued by an IAF-recognised body.
• ASEAN CSDT (Common Submission Dossier Template) — the modular dossier structure: administrative, executive summary, risk analysis, design verification & validation, clinical evidence, labelling.

Labelling and import:

• Decree 43/2017/NĐ-CP — labelling of goods; mandatory Vietnamese language for medical devices.
• Decree 111/2021/NĐ-CP — amends Decree 43 on labelling.
• Customs law — ATC (Authorised Trading Code) is required for importers of medical devices; verified at customs clearance against the Số lưu hành.

Note on numbering: Decree, Circular, and Resolution numbers and effective dates should be verified against the official publication on the MOH portal or the Official Gazette (Công báo) before relying on them.

This section walks the workflow end-to-end for each track, then sets out the 2022–2024 backlog crisis and the reform package that absorbed it.

1) Choosing the track — classification first, then dossier:

• Class A: surgical gauze, examination gloves, simple bandages, mechanical wheelchairs, basic infusion stands. Track: published declaration at provincial Sở Y tế.
• Class B: low-to-medium risk; e.g., examination electrodes, reusable surgical instruments, hearing aids. Track: MAC at MOH/DMEC.
• Class C: medium-to-high risk; e.g., infusion pumps, orthopaedic implants, dental implants. Track: MAC at MOH/DMEC.
• Class D: high risk; e.g., pacemakers, heart valves, absorbable sutures, certain IVDs. Track: MAC at MOH/DMEC with reinforced clinical evidence.
• Borderline cases: the classification rules in Circular 19/2021/TT-BYT and the AMDD GHTF rules govern; DMEC issues binding classification opinions on request, but turn-around is months. Plan classification work into the registration timeline.

2) Step-by-step process — Class A published declaration:

• Step 0 — Pre-submission. Identify the applicable national technical regulation (QCVN) or accepted international standard. Confirm the importer/manufacturer has a valid ATC. Prepare the applied standards declaration referencing the manufacturer technical file.
• Step 1 — Submission to provincial Sở Y tế. Online portals are operational in major provinces; smaller provinces still accept paper-and-disc submissions.
• Step 2 — The published declaration takes effect on submission. The Sở Y tế publishes the declaration number on its register typically within 10–15 working days; circulation may begin earlier in practice based on the submission receipt.
• Step 3 — Post-declaration: the declarant maintains the technical file; the Sở Y tế may inspect at any time.

3) Step-by-step process — Class B/C/D MAC at MOH/DMEC:

• Step 0 — Pre-submission. Confirm manufacturer ISO 13485 certificate (IAF-recognised body). For imported devices, confirm a current marketing authorisation or equivalent in the country of origin and prepare a Free Sale Certificate. Confirm the Vietnamese applicant's ATC.
• Step 1 — Online submission via dichvucong.moh.gov.vn. The dossier follows the ASEAN CSDT structure: Module 1 (administrative), Module 2 (executive summary), Module 3 (quality and pre-clinical), Module 4 (design verification & validation), Module 5 (clinical evidence), and labelling.
• Step 2 — Mandatory dossier contents: (i) Application form per Decree 98 annex; (ii) Letter of Authorisation (LoA) from the foreign manufacturer to the Vietnamese applicant, consularised where required; (iii) ISO 13485 QMS certificate; (iv) CSDT modules covering quality, design, and clinical evidence; (v) For reference-country pathway: SRA approval evidence (US-FDA 510(k) / PMA, EMA CE, PMDA approval, TGA ARTG, Health Canada licence, MFDS approval); (vi) Proposed Vietnamese-language label and IFU.
• Step 3 — Completeness review by DMEC: confirms formal completeness. Failure triggers a curing window before substantive evaluation starts.
• Step 4 — Substantive evaluation by DMEC expert groups: classification, design, clinical evidence, labelling, manufacturer qualification.
• Step 5 — Question rounds (yêu cầu bổ sung). Applicant cures within the period in the request; two rounds is typical, three signals risk of refusal.
• Step 6 — MAC issuance. The Số lưu hành is published on the MOH register and the product may circulate. Validity is 5 years.
• Step 7 — Post-MAC: variations under Decree 98 Article 33 (material vs minor); annual maintenance; recall and vigilance reporting under Circular 05/2022/TT-BYT; renewal at the 5-year mark.

4) Reference-country (SRA) fast track:

• Decree 98 Article 30/31 allows DMEC to rely on the technical evaluation of an SRA for eligible higher-class devices. Recognised SRAs: US-FDA, EMA, Japan PMDA, Australia TGA, Health Canada, Korea MFDS.
• Eligibility: the device must have a valid SRA approval for the same indication and substantially the same design; the applicant must still file a Vietnamese dossier incorporating Vietnamese-language labelling, an ATC-holding Vietnamese applicant, and a CFS.
• Practical effect: target timelines drop materially compared to the standard pathway, especially for Class C/D devices that would otherwise require full clinical evidence review.

5) The 2022–2024 backlog crisis (why Decree 07 and Decree 96 happened):

• Decree 98 took effect 1 January 2022. The new ASEAN CSDT structure, the stricter classification rules, and the expiry of many Decree-36-era MACs in 2022–2023 produced a large backlog at DMEC.
• Many MACs reached expiry while their renewal dossiers were still in evaluation; products fell off the market and hospital procurement was disrupted.
• Decree 07/2023/NĐ-CP (3 March 2023) was the emergency measure: automatic extension of MACs whose renewal dossiers were on file, transitional acceptance of in-process Decree 36 certificates, and a 12-month deferral of certain classification re-checks.
• Decree 96/2023/NĐ-CP (15 January 2024) extended the transition further and tightened the ATC regime to address compliance gaps revealed during the crisis.
• Operational impact: by mid-2024, the backlog had been materially reduced; by 2025–2026, DMEC processing for new MAC dossiers had returned closer to the statutory window, though not fully.

6) Practical pitfalls (the questions that most rejection cycles come from):

• Classification disputes: a manufacturer-stated Class B that DMEC reclassifies as Class C invalidates the original dossier and triggers a Class C re-filing — months of rework. Use Circular 19/2021 and the AMDD rules aggressively; request a binding classification opinion before submission for borderline devices.
• ATC currency: the importer/distributor ATC must be current at submission AND at customs clearance. ATC expiry between submission and clearance is a common cause of border-detained shipments after an MAC issuance.
• ISO 13485 issuing body: the certificate must come from an IAF-recognised certification body. Certificates from non-recognised bodies trigger a question round and often a refusal.
• SRA evidence mismatch: a US-FDA 510(k) for a different configuration of the device does not establish SRA eligibility for the Vietnam dossier. The SRA evidence must match the configuration, indication, and labelling of the Vietnamese filing.
• Vietnamese-language IFU: the instructions for use must be in Vietnamese, must mirror the registered indication one-to-one, and must include the manufacturer post-market contact required by Circular 05/2022.
• Material-vs-minor change determination: under Decree 98 Article 33, manufacturers routinely under-classify changes as minor when they are material. A misclassified change discovered at inspection invalidates the registration and triggers re-filing.