Vietnam Device Classification: Class A/B/C/D and Circular 05/2022
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: How many classes does Vietnam use?
A: Four: A (low risk), B (low-to-moderate risk), C (moderate-to-high risk) and D (high risk). Typical examples: Class A, a nasal aspirator; Class B, an infusion line; Class C, a ventilator; Class D, a prosthetic heart valve. Note that Vietnam has no “Class II” band. The classes do not map directly onto EU I/IIa/IIb/III or US I/II/III, so the class must be determined afresh under Vietnam’s own rules.
Q: What is the technical source of the classification rules?
A: Circular 05/2022/TT-BYT (in force 1 August 2022) sets out the Vietnamese classification system: 16 general classification rules, 7 separate rules for in vitro diagnostic (IVD) devices, and annexes with rules for invasive and other devices (for example rules 1 to 4 for non-invasive devices in Annex I). The rules are aligned with GHTF/IMDRF and ASEAN Medical Device Directive (AMDD) principles, which is why classification conclusions are comparable across ASEAN.
Q: Who is responsible for classification?
A: The applicant — the declarant of the Declaration of Applicable Standards or the applicant for circulation registration — classifies the device and publishes the result on the MOH electronic device portal. This differs from the Chinese approach of obtaining an opinion from a classification body: Vietnam places the responsibility on the holder, and the review stage checks it. A classification error is therefore the direct responsibility of the certificate holder.
Q: What exactly does classification determine?
A: Four things: (1) the filing route (Class A/B provincial declaration versus Class C/D national circulation registration); (2) the depth of documentation (Class C/D requires a CSDT, a risk analysis and clinical evidence); (3) the review timeline (as little as 10 working days on the fast track, up to about 90 days otherwise); and (4) the fee band (during the current reduced-fee period, VND 500,000 for Class A, VND 1,500,000 for Class B and VND 3,000,000 for Class C/D).
Q: What are the consequences of a wrong class?
A: At best the file is returned for correction and the clock restarts. At worst an inaccurate declaration affects later variations and the post-market compliance record. The most common error is to copy the class from the country of origin — writing a Chinese Class II device down as Vietnamese Class B — when the two rule sets are not the same.
Practical note: when in doubt, prepare evidence to the higher class rather than gamble on the lower one. If a reviewer upgrades a lower-class filing, the whole file must be redone and the clock restarts, which costs far more than preparing to the higher class from the outset. Citing the rule and clause number behind the classification conclusion in the filing markedly reduces the chance of challenge.
Verification checklist (26 October 2026): (1) Circular No. 05/2022/TT-BYT (1 August 2022), classification rules (16 general rules, the IVD-specific rules and Annex I); (2) the classification chapter of Decree 98/2021/NĐ-CP and the definitions in Article 2; (3) the classification principles of the ASEAN Medical Device Directive (AMDD); (4) the classification publication function on the MOH device portal.
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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