Product group · Medical Devices
Medical Devices HS Code Lookup & Import Procedure
Medical devices are the most tightly managed group because they directly affect human health. Here, getting the HS code right is only half the story — the more important half is the A/B/C/D risk classification of the device, which decides whether it needs a standard-conformity declaration, marketing authorisation, or an import licence. Errors at classification are the leading cause of stuck shipments or penalties. Enter your device in the tool below to find the HS code, duty and specialised-management policy.
Chapter 90Look up the HS code for this product group
Vietnam HS code (HS Code) & import–export tariff lookup
10,800+ HS codes · Import duty / VAT / 16 FTA preferences · Specialized management policies — AI understands plain-language descriptions.
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Overview
Most medical devices sit in Chapter 90 (medical, surgical and dental instruments and parts), with some items in other chapters (e.g. masks, dressings). The core of this group is not duty (most import duty is 0–5%, VAT a preferential 5%) but the Ministry of Health specialised-management system under Decree 98/2021/NĐ-CP. Every medical device must be risk-classified into four classes: A (low), B (low-medium), C (medium-high), D (high). The class drives the whole procedure: A/B usually have simpler declaration/authorisation, C/D require marketing authorisation at the Ministry of Health. Classification must be done by an eligible organisation and obtained before import.
Common HS codes
| HS code | Description |
|---|---|
| 9018 | Instruments for medicine, surgery, dentistry, veterinary use (needles, catheters, monitors…) |
| 9019 | Mechano-therapy appliances, massage apparatus, respiratory therapy devices |
| 9020 | Other breathing appliances, gas masks |
| 9021 | Orthopaedic appliances, splints, artificial teeth, hearing aids, implants |
| 9022 | X-ray apparatus, radiation equipment for medical use |
| 9025 | Thermometers (including clinical thermometers) |
| 9027 | Physical/chemical analysis instruments, diagnostic analysers |
| 9018.90 | Electro-diagnostic apparatus, electronic blood-pressure monitors |
| 3005 / 3006 | Cotton wool, bandages, gauze; pharmaceutical goods for medical use |
| 9026 | Instruments measuring flow/pressure (some medical devices) |
Duty rates & FTA preferences
Medical devices typically carry low MFN duty, commonly 0–5% depending on type; VAT is mostly a preferential 5% for most medical devices. Goods from FTA partners with a valid C/O may receive special preferential duty — ATIGA, EVFTA (many medical devices from the EU), VKFTA, AJCEP/VJEPA, RCEP, CPTPP. Since the duty base is already low, the value of doing it right lies in the specialised procedure rather than duty optimisation. Use the tool above to look up the specific HS code and applicable duty/VAT.
Applicable FTAs
Import procedure
- 1
Risk-classify the medical device (A/B/C/D)
The foundational step, done first. Engage an eligible classification organisation; base it on intended use, operating principle and risk level per the rules in Decree 98/2021/NĐ-CP (detailed in Circular 05/2022/TT-BYT). The classification result is a mandatory document.
- 2
Complete the corresponding declaration/authorisation or import licence
Class A: standard-conformity declaration. Class B/C/D: marketing authorisation (C/D filed at the Ministry of Health). Devices without authorisation imported for special purposes (research, training, aid, epidemic control…) require an import licence under Article 48 of Decree 98/2021/NĐ-CP. Authorised devices may be imported as needed, unlimited in quantity, under post-market management.
- 3
Determine the HS code
Cross-check the Circular 19/2024/TT-BYT list (effective 16/11/2024) and the technical documents for accurate classification.
- 4
Label the goods
Per Decree 98/2021/NĐ-CP and Decree 43/2017/NĐ-CP: the label shows the authorisation or import-licence number, lot/serial number, manufacture date, expiry (for sterilised devices); apply a Vietnamese sub-label if the original is insufficient.
- 5
File the declaration, pay duties & clear
Submit the declaration with the classification result, authorisation/licence (if applicable), CFS, ISO 13485, contract, invoice, C/O (if claiming FTA preference); pay import duty and VAT.
Specialised management & licences
Risk classification and marketing authorisation (Decree 98/2021/NĐ-CP)
All imported medical devices must be risk-classified (A/B/C/D) by an eligible organisation. The class drives the procedure: class A standard-conformity declaration; class B/C/D marketing authorisation (C/D at the Ministry of Health). The authorisation dossier usually includes the classification, ISO 13485 quality certificate, free-sale certificate (CFS) or FDA/CE certification, owner authorisation, and technical documents. Decree 98/2021/NĐ-CP was amended by Decree 07/2023/NĐ-CP and supplemented by Decree 04/2025/NĐ-CP (extending the validity of licences/authorisations).
Import licence (special cases)
An import licence applies only to devices without authorisation imported for special purposes: research, testing, calibration, training, repair, aid, epidemic control, or those on the mandatory-licence list (e.g. X-ray, MRI, life-support, implants). Authorised devices may be imported as needed.
Medical software
Standalone medical software (not bundled with a device), if the manufacturer states it is for diagnosis, treatment, monitoring or medical support, is managed as a medical device under Decree 98/2021/NĐ-CP.
Used medical devices
Importing used medical devices is restricted, allowed only in certain special cases and not for commercial purposes.
Common classification mistakes
Risk classification is the decisive step — not just the HS code
The biggest feature of medical devices: getting the HS code right is not enough; you must also determine the correct A/B/C/D risk class. Real-world example: a business imported an electronic blood-pressure monitor, classified it correctly under heading 9018 and assumed it only needed an ordinary customs declaration like any electronic device. But a blood-pressure monitor is a medical device (usually class B), so before import it needs a classification result from an eligible organisation and completed authorisation/declaration under Decree 98/2021/NĐ-CP. Without this step, the shipment cannot clear or be distributed, incurring storage costs and penalty risk. Lesson: for any item with a medical function, the first task is to determine whether it is a medical device and risk-classify it, in parallel with the HS code.
"Is it a medical device?" — the consumer-goods boundary
Many items sit on the boundary: thermometers, massagers, infrared lamps, masks… Whether a product falls under medical-device management (based on the intended use stated by the manufacturer) decides whether risk classification and authorisation are needed. Read the intended use and technical documents carefully.
Complete device vs parts and accessories
Parts and accessories of a medical device need their own code and policy determination; do not automatically lump them into the main device’s code.
Used medical devices
Importing used medical devices is restricted and not for commercial purposes — check carefully before ordering.
Frequently asked questions
Must every medical device be risk-classified A/B/C/D?
Yes. Under Decree 98/2021/NĐ-CP, all imported medical devices must be risk-classified by an eligible organisation, with the result obtained before import. The class drives whether the procedure is a declaration or marketing authorisation.
When is an import licence needed for a medical device?
When the device has no authorisation and is imported for special purposes (research, training, aid, epidemic control…) or is on the mandatory-licence list. Authorised devices may be imported as needed without a prior licence.
What are the import duty and VAT on medical devices?
Preferential import duty is usually 0–5% depending on type; VAT is mostly a preferential 5% for most medical devices. Goods from FTA partners with a valid C/O may receive special preferential duty. Look up the specific HS code for the rate.
Do blood-pressure monitors and thermometers need medical-device procedures?
Yes. These are medical devices (usually class B), requiring risk classification and completed authorisation/declaration under Decree 98/2021/NĐ-CP before distribution, even though the HS code may sit in heading 9018 or 9025.
Is medical software managed as a medical device?
Yes. Standalone medical software used for diagnosis, treatment, monitoring or medical support is managed as a medical device under Decree 98/2021/NĐ-CP.
Advisory
Need help with your shipment?
The Avenir team helps with HS classification, policy checks and import procedures for each shipment.