Test kits, reagents and biochemistry analysers form a separate branch of medical device management: in vitro diagnostic (IVD) devices. Although they share the Decree 98/2021/ND-CP frame with medical devices generally, IVDs have their own classification rule set based on the risk of a wrong test result, and that rule set decides whether a product takes the fast declaration route or full registration appraisal.
Legal basis
- Decree 98/2021/ND-CP on medical device management: in vitro diagnostic devices include reagents, calibrators, control materials and instruments used to examine specimens taken from the human body; classification principles by risk level in Articles 4 and 5.
- Circular 05/2022/TT-BYT on medical device classification: a separate IVD classification rule set by risk to the tested individual and risk to public health; the A, B, C, D frame is retained in Circular 24/2026/TT-BYT (effective 01 July 2026).
- Rules on the registration dossier for class C and D devices under the ASEAN common submission dossier template (CSDT) and the standards declaration procedure for classes A and B.
Must test kits be registered like medical devices?
Yes: test kits and IVD reagents are medical devices under the very definition of Decree 98/2021 and must complete circulation procedures before being sold to laboratories and hospitals in Vietnam. But registration here has two different routes by classification result: a product in class A or B performs the standards declaration procedure at the Department of Health of the registration establishment locality, and may circulate once a declaration number is issued; a product in class C or D must file a marketing registration dossier and be granted a registration number by the Ministry of Health after appraisal. A foreign owner performs these procedures through a named establishment in Vietnam (a representative office or an authorised unit meeting prescribed conditions), and that establishment is responsible for classification and in-market quality of the IVD as with any device. A common mistake is importing test kits as samples or research goods and then using them for commercial testing services: a product used for commercial diagnostic purposes needs the corresponding circulation number regardless of imported quantity.
How are IVDs classified A, B, C, D?
The IVD classification rules in Circular 05/2022/TT-BYT assess two risk axes at once: risk to the individual if the test result is wrong, and risk to public health if wrong results spread. On those axes: routine parameter tests with good internal quality control and limited consequences of error (many basic biochemistry and haematology tests) sit in classes A and B; tests whose results decide important treatment, and tests for diseases with medium transmissibility, sit in class C; and class D is for the highest risk tests, typically blood and blood product screening for dangerous infectious agents, and tests for infectious diseases capable of causing death or strong spread where a false negative has serious community consequences. The practical consequence is that the same testing technology can fall into different classes by indication: a rapid home-use kit for an ordinary indication is in a lower class, while a kit on the same principle used to screen donated blood units is in class D. The named establishment classifies under the rules and bears responsibility for the result; where torn between two classes, the legally safe direction is to apply the higher risk class or seek the authority view, because a post-check finding of under-classification is handled as circulating a product without proper procedure.
What does an IVD registration dossier contain?
For class C and D IVDs, the registration dossier is built on the ASEAN common submission dossier template (CSDT) structure, including: product information and intended use; risk management documentation and essential safety and performance requirements; analytical and clinical performance evidence of the test (sensitivity, specificity, detection limit, reagent stability); Vietnamese labels and instructions for use; the certificate of free sale (CFS) and the manufacturer quality management system certification; and documentation on storage and transport conditions, a special point for IVDs because most reagents require a cold chain and have a short in-use shelf life, so the file must show stability data corresponding to Vietnamese climate conditions. Class A and B IVDs on the declaration route still need a corresponding declaration-level file, including the applied standards declared by the establishment and documents evidencing that the product meets those standards. Changes of manufacturer, reagent composition changes or indication extensions after a circulation number is granted are changes requiring change or supplement registration procedures as prescribed and may not be applied unilaterally.
How long does appraisal take?
The declaration route for classes A and B spends most of its time in enterprise dossier preparation. The class C and D registration route at the Ministry of Health has an appraisal period under the authority dossier processing process, and in practice depends heavily on the number of supplementation rounds on performance documentation; IVD dossiers are supplemented most often on sensitivity and specificity evidence on a suitable sample population and on reagent stability data. An IVD importer should build its launch schedule on a scenario with supplementation rounds, and manage cold chain and shelf-life risk during the wait for a registration number: short-shelf-life reagents imported before a number is granted for procedure completion purposes must be managed within the permitted frame and may not be diverted to commercial sale. A product holding reference authority certification (EU CE IVDR, US FDA) has a performance evidence advantage in the dossier but must still complete classification and circulation procedures in Vietnam.
Frequently asked questions
Must test kits be registered like medical devices?
Yes. Test kits and IVD reagents are medical devices under Decree 98/2021 and must complete circulation procedures before sale in Vietnam: classes A and B declare applied standards at the Department of Health; classes C and D register at the Ministry of Health after appraisal. Importing as samples or research goods and then using them for commercial testing services is not a proper procedure.
How are IVDs classified A, B, C, D?
Under the IVD-specific rules in Circular 05/2022, based on risk to the individual and public health risk if a test result is wrong: routine tests in classes A and B; tests deciding important treatment in class C; class D for the highest risk tests such as blood screening for dangerous infectious agents. The same technology can fall into different classes by intended use; the named establishment self-classifies and bears responsibility.
What does an IVD registration dossier contain?
Classes C and D file on the CSDT common dossier structure: product information, risk management, analytical and clinical performance evidence (sensitivity, specificity, stability), Vietnamese labels and instructions, the CFS and manufacturer quality certification, and cold chain storage data. Classes A and B hold a corresponding declaration file including the applied standards.
How long does appraisal take?
Classes A and B take the declaration route and are fast, with most time in enterprise dossier preparation. Classes C and D are appraised at the Ministry of Health and usually face supplementation rounds on performance evidence and reagent stability data, so launch schedules should assume that scenario; CE IVDR or FDA certification is an evidence advantage but does not replace the Vietnam procedure.
This article has been quality-reviewed by the FLAW AI Legal Council