Almost every medical-device compliance failure in Vietnam starts with a classification error: classifying lower than reality to take the fast declaration route, or over-classifying and delaying a project by a year. Reading Decree 98/2021/ND-CP’s A, B, C, D system correctly comes before any market procedure.
Classes A, B, C, D: by potential risk level
Article 5 of Decree 98/2021/ND-CP divides medical devices into four risk classes: class A low risk (dressings, ordinary hospital beds), class B low-medium (syringes, some basic diagnostics), class C medium-high (ventilators, advanced imaging) and class D high risk (cardiovascular implants, implantable materials). Classification is performed by a classification organisation announced as eligible by the Ministry of Health, applying the decree’s principles and rules — the same product can land in different classes depending on the manufacturer’s declared intended use, so the classification file must stay consistent with the later marketing and advertising files.
Two market routes: declaration for A and B, registration for C and D
Article 21 of Decree 98/2021/ND-CP designs two routes: class A and B devices complete a standards declaration at the provincial Department of Health where the declaring organisation is based — once the declaration number issues, the product may circulate; class C and D devices must register for circulation at the Ministry of Health and receive a circulation registration number after technical and, as applicable, clinical appraisal. Declaration and circulation numbers have indefinite validity under the current frame — but the holder must maintain conditions and update on changes to the product, manufacturer or applied standards. Domestically made-to-order devices, aid devices and other special cases have their own procedure routes to check before importing or manufacturing.
Import and advertising: the two most-fined compliance points
An imported device must already carry a valid circulation or declaration number, and the importing and distributing business must meet the medical-device business conditions of Decree 98/2021/ND-CP (for classes C and D, added conditions on warehousing, transport and technical staff). On advertising: device advertising content must match the circulation file and, in statutory cases, obtain advertising-content confirmation before release — inflating functions beyond the registered file is the sector’s most-fined and most-removed violation. A business should lock a single pipeline: classification → market authorisation → advertising, with no team allowed to run ahead of the previous step’s papers.
Frequently asked questions
What are the newest medical-device classes?
Under Article 5 of Decree 98/2021/ND-CP there are four classes by potential risk: A low risk, B low-medium risk, C medium-high risk and D high risk. Classification is performed by an announced eligible classification organisation under the decree’s principles and rules, based on the intended use the manufacturer declares for the product.
How is a circulation number obtained?
It follows the class: classes A and B take the standards-declaration route at the provincial Department of Health; classes C and D must register and obtain a circulation registration number at the Ministry of Health under Article 21 of Decree 98/2021/ND-CP. Only after the declaration or circulation number issues may the device lawfully circulate on the Vietnamese market.
What are the conditions for importing medical devices?
A device imported for circulation must already hold a circulation or declaration number matching its class, and the importer must meet the medical-device business conditions of Decree 98/2021/ND-CP — for classes C and D with added conditions on warehouse facilities, storage and transport conditions, and personnel. Devices under price management or special lists may carry further sector requirements at the time of import.
How is medical-device advertising regulated?
Advertising content must match the device’s circulation file and, in statutory cases, obtain advertising-content confirmation before release. Advertising false functions, exceeding the registered scope, or advertising without required confirmation draws administrative fines and forced removal — businesses should cross-check every advertising asset against the circulation file before running a campaign.
FLAT Law Firm — FLAT Law Firm advises on medical-device compliance: A–D classification, standards-declaration and circulation-registration files under Decree 98/2021, and advertising-content reviews.
This article has been quality-reviewed by the FLAW AI Legal Council