Vietnam IVD & SaMD Regulation: Classification, Approval, Labelling

In-vitro diagnostic devices (IVDs) and software as a medical device (SaMD) are both regulated under Decree 98/2021/NĐ-CP, but with different levels of operational maturity. This page walks through Vietnam's current IVD framework end-to-end — classification, approval workflow, expedited pathway, product grouping, testing evidence, and labelling — then covers what SaMD sponsors need to know about the guidance gap.

Scope: what counts as an IVD in Vietnam

Under Decree 98/2021 and Circular 05/2022/TT-BYT, an IVD is a reagent, calibrator, control material, test kit, instrument, apparatus, equipment, receptacle, or software intended by its manufacturer to be used *in vitro* for the examination of specimens (including blood, tissue, urine, and other human-derived samples) for the purpose of:

• Diagnosis or aid in diagnosis of a disease or physiological state
• Screening (asymptomatic populations or blood-donor screening)
• Monitoring of therapy, disease progression, or drug levels
• Determination of a patient's predisposition to a condition (companion diagnostics)
• Selection or exclusion of a therapy (companion diagnostics)

Products marketed only for research use only (RUO) and general-purpose laboratory equipment without an IVD intended use are outside the medical-device regime — but the burden is on the sponsor to demonstrate that RUO framing is genuine (labelling, marketing material, and quality-system documentation must be consistent with RUO status).

Risk classification: A, B, C, D under the AMDD IVD rules

Circular 05/2022/TT-BYT sets out IVD-specific risk-classification rules aligned to the ASEAN Medical Device Directive (AMDD) framework. The four classes reflect combined individual and public-health risk:

• Class A — lowest risk. Examples: general laboratory reagents (buffers, staining solutions) without a specific diagnostic claim, specimen receptacles, reagent-grade water for lab use. Pathway: published declaration at the provincial Sở Y tế.
• Class B — moderate individual risk, low public-health risk. Examples: pregnancy self-tests, cholesterol tests, fertility self-tests, blood-glucose self-monitoring devices, urinalysis strips for professional use. Pathway: MAC at IMDA (formerly DMEC).
• Class C — high individual risk or moderate public-health risk. Examples: PSA tests for cancer diagnosis, HbA1c for diabetes management, most infectious-disease tests other than the highest-risk pathogens, HLA typing for non-transplant use, self-tests for infectious diseases marketed OTC. Pathway: MAC at IMDA with fuller technical and clinical evaluation.
• Class D — highest risk. Examples: HIV, HCV, HBV, HTLV, and syphilis tests intended for blood/organ/tissue donor screening; tests for the highest-consequence public-health pathogens; companion diagnostics that gate access to specific therapies. Pathway: MAC at IMDA with the deepest evidence review.

Classification runs primarily on intended use (what the manufacturer claims), not what the analyte technically is: an HIV screening test used for donor-blood screening is Class D, while the same analyte in a professional-use context might be classified differently. IMDA's classification determination is binding for the Vietnamese market and can differ from a US-FDA or EU-IVDR classification for the same product.

Product grouping — one MAC, multiple SKUs

Vietnam accepts several grouping constructs so sponsors don't need one MAC per SKU:

• IVD Family — a set of products from the same manufacturer that share the same intended use, analyte, and technology (e.g., a range of monoclonal antibody reagents against different tumour markers).
• IVD Kit / Test kit — a set of reagents and components packaged together to perform a specific analysis (e.g., an HIV antibody kit that includes conjugate, substrate, wash buffer, and calibrators).
• IVD Group — a set of IVDs that share the intended use and technology but have different analytes when packaged for a common clinical workflow (e.g., a respiratory-virus multiplex panel).
• System / instrument + dedicated reagents — an analyser plus its dedicated reagent lines can be filed under a single grouped MAC when the manufacturer positions them as an inseparable system.

Grouping decisions materially affect the number of dossiers, the number of MACs to maintain, and the change-control burden. Get grouping right at the start — restructuring after the first MAC is issued is significantly harder than proposing the right structure up front.

Testing and evidence expected in the IVD dossier

An IVD dossier under Decree 98/2021 and Circular 05/2022 typically covers, scaled to class:

• Analytical performance — accuracy, precision (repeatability + reproducibility), analytical sensitivity (LoD/LoQ), analytical specificity (interference, cross-reactivity), linearity, measurement range, matrix effects, sample-stability, and reagent-stability data. Class C/D dossiers are expected to include multi-site precision data.
• Clinical performance — clinical sensitivity and specificity in the intended-use population against a defined reference standard, and for higher-risk classes real-world clinical performance data (studies conducted at Vietnamese sites where such data is available and requested).
• Traceability and calibration — metrological traceability of results to higher-order reference materials or methods where recognised international standards exist.
• Quality-management system — ISO 13485:2016 QMS certificate covering the manufacturing site, plus lot-release procedures for reagent products.
• Labelling and IFU — reviewed against Circular 05/2022 and the general labelling framework in Decree 37/2026/NĐ-CP (in force 23 January 2026; consolidates and replaces Decree 43/2017 + Decree 111/2021).
• Free-sale evidence — CFS from the manufacturer's home market for imported products (see the SRA/reference-country section below).

Expedited / reference-country (SRA) pathway

Decree 98/2021, Articles 30 and 31, provide a reference-country (SRA — Stringent Regulatory Authority) fast track available to IVDs already approved by US-FDA, EMA, Japan PMDA, Australia TGA, Health Canada, or Korea MFDS. Under the SRA pathway, IMDA relies on the reference authority's technical evaluation and focuses its own review on Vietnamese-market specifics: labelling, IFU translation, Vietnamese ATC-holding applicant, CFS, and locally-relevant clinical evidence where the reference approval was granted for a different population.

Two important limits:

• The SRA evidence must match the configuration, intended use, and labelling of the Vietnamese filing. A 510(k) clearance for a different intended use or a different analyte configuration does not qualify.
• The Vietnamese applicant still submits a Vietnamese-language dossier, holds an Authorised Trading Code (ATC), and complies with the labelling and post-market obligations set out on /medical-device/labelling/ and /medical-device/post-market-quality/.

The SRA pathway shortens IMDA's technical evaluation window but does not remove the need for a Vietnamese registration number (Số lưu hành) on the product.

IVD labelling — the short version

IVD labels follow the general medical-device labelling regime detailed on /medical-device/labelling/, with a few IVD-specific additions:

• The registration number (Số lưu hành) issued by IMDA (Class B/C/D) or the provincial Sở Y tế (Class A) must appear on the immediate package in Vietnamese.
• The intended use, specimen type, and analyte must be stated in Vietnamese; discrepancy between the labelled intended use and the registered indication is a top-cited post-market non-conformance.
• Storage conditions, shelf life, lot number, and expiry date are mandatory on the primary and secondary packaging.
• ISO 15223-1 harmonised symbols (in-vitro diagnostic use, single-use, temperature range, batch code, catalogue number, use-by date, manufacturer, authorised representative) are accepted alongside Vietnamese text.
• Instructions for use (IFU) must be in Vietnamese for lay-use IVDs (self-tests). For professional-use IVDs, the IFU may be in Vietnamese plus a second working language, and a controlled electronic IFU (e-IFU) is permitted under Circular 05/2022/TT-BYT when the URL is stable, the version matches the labelled device, and the IFU is freely downloadable.

Software as a Medical Device (SaMD) — current state

Vietnam regulates SaMD as a medical device when the software meets the medical-device definition: intended for diagnosis, monitoring, prevention, or treatment of disease, or for gating clinical decisions such as therapy selection. Standalone consumer wellness apps without a medical purpose are not medical devices and fall outside the regime.

Risk classification for SaMD uses the same A/B/C/D rules that apply to other devices. IMDA has referenced the IMDRF SaMD categorisation framework (N10, N12) in industry consultations, but Vietnam has not codified a SaMD-specific classification rule in Circular 05/2022 or a successor circular.

The main practical gap for SaMD sponsors as of 2026: neither Decree 98/2021 (as amended by Decrees 07/2023, 96/2023 and 04/2025) nor Circular 05/2022 provides operational SaMD-specific guidance on:

• Software change control and how to file variations for algorithm updates
• Cybersecurity requirements for connected devices
• AI/ML model lifecycle — how to register a "locked" versus "adaptive" model, and how to file re-trained model versions
• Real-world performance monitoring and how post-market SaMD updates are treated

In practice, SaMD dossiers are structured following IMDRF, US FDA Digital Health, and EU MDR/IVDR software guidance, and sponsors respond iteratively to IMDA review questions. Companies planning SaMD launches in Vietnam should build in a longer review cycle and be ready to defend design decisions against international guidance where Vietnamese guidance is silent.

Core framework:

• Decree 98/2021/NĐ-CP — foundational instrument for medical-device and IVD management; in force 1 January 2022.
• Decree 07/2023/NĐ-CP — first amendment; auto-extended legacy IVD registration numbers (issued 2014–2019) to 31 December 2024 during the post-pandemic supply pressure.
• Decree 96/2023/NĐ-CP — second amendment; tightened ATC and import-licence requirements.
• Decree 04/2025/NĐ-CP — third amendment; in force 1 January 2025. Preserves the labelling framework and refines classification, registration-dossier requirements and post-market obligations.
• Circular 05/2022/TT-BYT — implementing details for classification, registration, labelling, recall and post-market vigilance; includes IVD-specific risk-classification rules.
• Circular 19/2021/TT-BYT — classification rules under the AMDD framework; the general A/B/C/D taxonomy that IVDs sit within.
• Circular 10/2023/TT-BYT — list of medical devices in Group 2 (specific management measures); includes IVDs subject to closer supervision.

Labelling and technical:

• Decree 37/2026/NĐ-CP — general goods labelling; in force 23 January 2026; consolidates and replaces Decree 43/2017/NĐ-CP + Decree 111/2021/NĐ-CP.
• ISO 15223-1 — internationally harmonised symbols for IVD and medical-device labels.
• ISO 15189 — medical laboratories — requirements for quality and competence (relevant for the clinical-performance context in which the IVD will be used).
• ISO 13485:2016 — QMS for medical-device and IVD manufacturers.
• ISO 17511 — metrological traceability of values assigned to calibrators, control materials, and clinical samples.

SaMD reference (not directly binding in Vietnam, routinely used in dossiers):

• IMDRF SaMD framework — N10 (definition), N12 (categorisation), N23 (QMS for SaMD), N41 (clinical evaluation), and successor documents on AI/ML.
• US FDA Digital Health — SaMD guidance, pre-cert programme lessons, and AI/ML-specific guidance (predetermined change control plan).
• EU MDR (Regulation 2017/745) — Annex VIII Rule 11 for software classification; used as a comparator.
• EU IVDR (Regulation 2017/746) — for IVD software specifically.

Penalty framework:

• Decree 117/2020/NĐ-CP (as amended by Decree 124/2021/NĐ-CP) — administrative penalties covering IVD-registration and labelling non-conformance.

Note: SaMD-specific Vietnamese guidance has been on the IMDA workplan in industry consultations for several cycles; sponsors should monitor for a dedicated circular. Decree, Circular, and Resolution numbers and effective dates should be verified against the MOH portal (moh.gov.vn), the National Legal Database (vbpl.vn), and the Official Gazette (Công báo) before relying on them.

2025 — Decree 04/2025 refinements: The third amendment to Decree 98/2021 (in force 1 January 2025) preserves the IVD framework of Circular 05/2022/TT-BYT and tightens correspondence between the registered intended use and on-label wording. Post-market inspections in 2025 flagged IVD labels that broaden the intended use beyond the registered indication (e.g., extending a professional-use screening test to over-the-counter self-test claims) as a top non-conformance.

2024 — IVD registration-number transition deadline closed: Legacy IVD registration numbers issued 2014–2019 expired on 31 December 2024 unless re-registered under Decree 98/2021. The transitional extension put in place by Decree 07/2023 for the post-pandemic supply period ended; holders that missed the deadline must file new dossiers.

Ongoing — Industry consultation on SaMD: IMDA and MOH have engaged industry on the need for SaMD-specific guidance covering software change control, AI/ML model lifecycle, cybersecurity, and post-market performance monitoring. As of 2026 no formal SaMD-specific circular has been issued. In parallel, sponsors of AI/ML IVDs (image-analysis pathology, clinical decision-support for lab results) are increasingly submitting dossiers structured against IMDRF and US-FDA predetermined-change-control frameworks and responding iteratively to IMDA review questions.

2023 — IVD supply relief in Decree 07/2023: During the post-pandemic supply pressure, Decree 07/2023 explicitly extended IVD registration numbers and import permits to allow continuity of laboratory diagnostic services. This transitional layer has since been superseded, but appears in older MAC certificates that are still valid until renewal.

SRA-pathway adoption: Sponsors increasingly file IVDs through the reference-country (SRA) fast track under Decree 98 Articles 30/31. For high-risk analytes (HIV, HCV, HBV blood-donor screening; oncology companion diagnostics), pairing an EMA/FDA/PMDA approval with a Vietnamese-market dossier and CFS shortens IMDA's technical evaluation window materially — provided the SRA evidence matches the Vietnamese configuration and labelling verbatim.