Vietnam MOH Device Register: 108,600 Valid Registrations and a 3× Decree 98 Surge

Executive Summary

Vietnam is one of Southeast Asia's fastest-growing medical device markets, and its public register reflects both rapid expansion and a heavily fragmented supplier base. Our analysis of the Vietnam Ministry of Health (MOH) device register finds 108,658 valid (in-force) device registrations as of March 2026, held by 21,871 distinct applicants and organized under 108,619 announcement (registration) numbers.

Three structural findings define the market:

1. A regulatory-driven registration surge. The number of new device registrations recorded each year tripled from 7,335 in 2021 to 23,070 in 2022 — a direct consequence of Decree 98/2021/ND-CP, Vietnam's overhaul of medical-device management, which took effect on 1 January 2022 and triggered a wave of new registrations and migration from the prior framework.
2. An extraordinarily fragmented applicant market. The top 10 applicants hold just 9.1% of registrations; the top 50 hold 18.2%. With an Herfindahl-Hirschman Index (HHI) of just 16, Vietnam's register is one of the most fragmented device markets we have analyzed — a long tail of more than 21,000 importers, distributors, and regional representatives.
3. Global majors anchor the top of a domestic-dominated tail. Roche Vietnam (2,601 registrations), Abbott, Siemens Healthineers, B. Braun, Becton Dickinson, Medtronic, and Johnson & Johnson lead the concentration table, but domestic Vietnamese importers (Nam Phương, Vạn Niên, Nhật Anh, Minh Nhật, Phương Đông) and regional representatives (Andaman Medical) occupy the bulk of the long tail.

This article breaks down the Vietnamese register by annual registration volume, applicant concentration, and the regulatory reform that reshaped the market — giving regulatory strategists and market-access teams a quantitative foundation for Vietnam planning.

Data Source and Methodology

All statistics in this article are derived from our direct analysis of the Vietnam Ministry of Health public medical device register (public extract dated 10 March 2026). The dataset contains 108,658 device registration records, all with a status of Còn hiệu lực ("still valid"/in-force). Each record carries a file code, announcement number (the registration mechanism by which MOH publishes approved devices), announcement date, applicant company name, device name, and status.

Annual registration volumes were computed by extracting the year from the announcement date. Applicant concentration was computed using standard Herfindahl-Hirschman Index (HHI) methodology, where each applicant's share (as a percentage) is squared and summed across all 21,871 applicants. Company names appear in Vietnamese in the source; this article provides English identifications alongside the original names. Percentages are calculated against the total record count (108,658) unless otherwise noted. The 2026 figure reflects a partial year (January–March 2026, the extract date).

Vietnam's Regulatory Framework: Decree 98 and the Re-Registration Wave

Vietnam regulates medical devices under Decree 98/2021/ND-CP on the management of medical devices, issued on 8 November 2021 and effective from 1 January 2022. The decree replaced three prior instruments — Decree 36/2016/ND-CP, Decree 169/2018/ND-CP, and Decree 03/2020/ND-CP — and represented a major structural reform of how devices enter the Vietnamese market.

Key features of Decree 98 that reshaped registration volume:

• A shift from pre-inspection to post-inspection for product registration, reducing pre-market administrative procedures.
• A new classification framework aligned with the IMDRF/GHTF four-tier system (Class A through D), replacing the older structure and requiring devices to be mapped to the new classes.
• Re-registration and migration of devices previously authorized under the superseded decrees, driving a one-time surge of registration activity in 2022–2023.
• Price-management measures, including declaration of import cost (CIF) or production cost for certain devices — a provision that drew industry concern during implementation.

The decree has since been amended by Decree 07/2023/ND-CP (3 March 2023) and Decree 04/2025/ND-CP, refining classification, fee, and procedural provisions.

Operationally, Vietnam splits device oversight across bodies: within the Ministry of Health, the Infrastructure and Medical Device Administration (IMDA) — renamed from the former Department of Medical Equipment and Construction (DMEC) in January 2025 — issues import licenses and registration numbers for Class C and D devices and issues certificates of free sale; provincial Departments of Health handle notification of Class A and B devices. The Ministry of Science and Technology (MOST) performs regulatory functions for domestically manufactured devices. Two implementation details shaped the 2022–2025 register dynamics: from 1 January 2024, Class C and D dossiers must be submitted in the ASEAN Common Submission Dossier Template (CSDT) format, and Decree 07/2023 followed by Decree 04/2025 repeatedly auto-extended the validity of import licenses issued under the prior framework (ultimately to 30 June 2025) while very few new Class C/D Market Authorization licenses were issued in the transition. Marketing authorizations themselves do not expire. This split is reflected in the register's announcement-number structure, where many devices appear under applicant companies that act as the local registration and import interface for foreign manufacturers.

Vietnam's medical device market was valued at approximately $1.7 billion in 2024 (the eighth-largest in the Asia-Pacific region), and is projected to reach roughly $2.5 billion by 2029 on mid-single-to-high-single-digit annual growth. More than 90% of medical equipment in use is imported — a statistic that aligns directly with the registration pattern visible in the register: the most prolific applicants are the local entities (Vietnam subsidiaries, domestic importers, and regional representatives) through which foreign manufacturers introduce equipment.

The Decree 98 Surge: Annual Registration Volume 2017–2026

The clearest signal in the Vietnamese register is the discontinuity in annual registration volume at the moment Decree 98 took effect:

Three observations:

• The 2022 step-change is the signature event. Registrations jumped from 7,335 in 2021 to 23,070 in 2022 — a 3.1× increase concentrated in the first year of Decree 98's operation. This is consistent with the re-registration and new-classification migration that the framework change required, on top of baseline market growth.
• The 2020 bump reflects COVID-19. The rise to 7,224 in 2020 (from 3,789 in 2019) tracks the emergency registration of diagnostics, ventilators, and personal protective equipment during the pandemic, before the structural surge two years later.
• 2025 nearly matched the 2022 peak. At 22,734 registrations, 2025 approached the all-time 2022 high, indicating that Vietnam's device market has settled into a sustained high-volume registration rhythm well above its pre-Decree-98 baseline.

For market-access teams, the practical implication is that the register's current size and shape are still partly a regulatory artifact of Decree 98, not purely organic demand. But the sustained 14,000–23,000 annual run-rate from 2023 onward indicates genuine, broad-based registration activity across a large and growing supplier base.

Applicant Concentration: A Fragmented Long Tail

Among 108,658 valid registrations, there are 21,871 distinct applicants — an extraordinarily large and diffuse base. The top applicants are a mix of global-medtech Vietnam subsidiaries and domestic Vietnamese importers:

Concentration metrics:

• Top 5 applicants: 6,822 registrations (6.3%)
• Top 10 applicants: 9,885 registrations (9.1%)
• Top 20 applicants: 13,364 registrations (12.3%)
• Top 50 applicants: 19,776 registrations (18.2%)
• HHI: 16 (highly fragmented)

An HHI of 16 is exceptionally low — far below the 2,500 threshold for high concentration and lower than most comparator markets. The implication is structural: no single applicant — not even the market leader — controls a meaningful share of registrations. Roche's 2.39% is the largest single position, and the combined top 50 reach only 18.2%. The remaining ~81.8% of registrations are spread across more than 21,800 other applicants.

This fragmentation has two drivers. First, Vietnam's market-access model relies heavily on local importers and distributors that register products on behalf of many foreign manufacturers, producing a large population of mid-sized domestic holders. Second, the Decree 98 re-registration wave drew many previously informal or smaller importers into the formal register, expanding the applicant base substantially. The domestic names in the top tier (Nam Phương, Vạn Niên, Nhật Anh, Minh Nhật, Phương Đông) and regional representatives (Andaman Medical) illustrate how the registration layer is held locally.

Implications for market entry. Foreign manufacturers entering Vietnam face a genuinely competitive registration landscape with many viable local partners, but also an environment where registration control is widely dispersed. As in other markets where registrations are held by local entities rather than the manufacturer directly, the choice of registration/import partner is a commercial relationship that affects renewal, modification, and transfer of registrations — and in a market this fragmented, partner due diligence matters more than partner scarcity.

Global Majors vs. the Domestic Long Tail

The register's top tier is dominated by the in-vitro diagnostics and imaging multinationals that supply Vietnam's hospital and laboratory networks. Roche Vietnam alone holds 2,601 registrations — 2.4% of the entire register and more than any other single applicant — reflecting Roche's dominant IVD position in Vietnam's reference-laboratory and hospital-testing market. Siemens Healthineers (imaging and IVD), Abbott (IVD and point-of-care), B. Braun (hospital consumables and infusion), Becton Dickinson (surgical and diagnostic consumables), Medtronic (cardiovascular and neuromodulation), and Johnson & Johnson (surgical and orthopedics) round out the global-major presence.

Yet the named global majors collectively account for only an estimated 9–10% of all registrations. The remainder is held by domestic Vietnamese importers and distributors, smaller regional players, and specialized representatives. This is the defining commercial structure of the Vietnamese device market: global brands supply the high-value diagnostic, imaging, surgical, and cardiovascular categories, while a vast domestic distributor layer handles the broad mid- and low-risk segment — disposables, consumables, basic monitoring, and general hospital supplies.

Vietnam in Regional Context

Within ASEAN, Vietnam occupies a distinctive position. Unlike Singapore (a concentrated, WHO-Maturity-Level-4 reference gateway with a relatively small applicant base) or Malaysia (MDSAP-member with a more consolidated importer layer), Vietnam combines a large population, a reliance-based classification framework that recognizes prior approvals from reference agencies, and a very large, fragmented registration base. Decree 98's alignment with IMDRF classification also means that a well-prepared ASEAN Common Submission Dossier Template (CSDT) can be adapted for Vietnam with reduced incremental effort, and that devices already approved by reference agencies (US FDA, EU, Japan PMDA, Australia TGA) can leverage recognition pathways for faster Class A/B notification.

For manufacturers pursuing an ASEAN strategy, Vietnam's combination of scale and fragmentation makes it a high-volume market that rewards a strong local registration/import partner and an awareness of the post-Decree-98 registration rhythm rather than a market that can be accessed through a single dominant gateway.

Key Takeaways

• 108,658 valid device registrations held by 21,871 distinct applicants as of March 2026
• New registrations tripled from 7,335 (2021) to 23,070 (2022) when Decree 98/2021/ND-CP took effect, and remain elevated (22,734 in 2025)
• The applicant market is highly fragmented (HHI 16) — the top 50 applicants hold only 18.2% of registrations
• Roche Vietnam leads with 2,601 registrations (2.4%), followed by Abbott, Siemens Healthineers, B. Braun, BD, Medtronic, and J&J; domestic importers and regional representatives fill the long tail
• Decree 98/2021/ND-CP shifted Vietnam from pre-inspection to post-inspection and triggered the re-registration wave; amended by Decree 07/2023 and Decree 04/2025
• Vietnam's IMDRF-aligned, reference-agency-recognizing framework makes it a high-volume, partner-dependent market within an ASEAN CSDT strategy

Data Source

Analysis sample: Vietnam Ministry of Health public medical device register, public extract dated 10 March 2026, 108,658 in-force device registration records. Annual volumes computed from announcement-date year. Applicant concentration computed via HHI across all 21,871 applicants. Applicant names identified and transliterated from Vietnamese. Regulatory framework, market size, and Decree 98/2021/ND-CP details sourced from the Vietnam Ministry of Health, Pacific Bridge Medical, Cisema, Emergo by UL, the US Department of Commerce Country Commercial Guide, and AmCham Vietnam; subsequent amendments (Decree 07/2023, Decree 04/2025) and the IMDA (formerly DMEC) rename from public Vietnamese legislative records. All numbers reflect the public register and may differ slightly from MOH's internal records due to the timing of data publication.