Importing medical face masks into Vietnam falls under the medical device management scope of the Ministry of Health, since medical face masks are classified as Class A medical devices (low risk) — making contact only with the skin and mucous membranes, without deep intervention into the body. This is an important distinction from ordinary cloth masks, which are not subject to medical device management.
Since January 1, 2018, the requirement for a Class A medical device import license has been completely replaced by the applicable standard declaration procedure — a point many businesses newly entering the market are not yet aware of, leading them to prepare the wrong type of documentation when carrying out the medical face mask import procedure.
In this article, 3W Logistics presents the complete medical face mask import procedure under the current legal regulations and the latest tariff schedule — from legal conditions, the 8-digit HS code, tax calculation, documentation, a step-by-step process, to real-world risks, from the perspective of a forwarder experienced in handling imported medical device goods.
1. Legal conditions for importing medical face masks into Vietnam
Medical face masks are not on the list of goods prohibited from import; however, as a Class A medical device, they must undergo an applicable standard declaration at the Department of Health before being circulated on the market.
| Condition | Detailed Content |
|---|---|
| Medical device classification | Medical masks (Medical Mask, Surgical Mask) are classified as Class A medical devices — a low-risk category, requiring a classification confirmation document before declaration |
| Applicable standard declaration | Fully replaces the import license, effective January 1, 2018; documentation is submitted to the Department of Health where the importing entity is headquartered, and a Declaration Receipt Form is issued |
| Letter of Authorization from the owner | If the importing entity is not the owner of the declaration number, a Letter of Authorization from the manufacturer, consularly legalized, is required |
| Quality management certification | A certificate confirming the manufacturer meets ISO 13485 (or equivalent) standards, valid at the time of declaration |
| Product labeling | Under Article 54 of the Decree on medical device management: product name, name/address of the responsible organization, origin; if the original label lacks sufficient Vietnamese content, a supplementary label is required |
Practical note: The most important point in the medical face mask import procedure is that businesses no longer need to apply for an import license from the Ministry of Health, as was required before 2018 — instead, they only need to complete the applicable standard declaration at the local Department of Health, which is significantly simpler and faster. However, it’s important to clearly distinguish medical face masks (subject to medical device management, requiring standard declaration) from ordinary cloth masks used in daily life (not subject to this management) — many businesses mistakenly apply the wrong procedure, causing their documentation to be rejected or leading them to prepare unnecessary extra paperwork.
2. 8-digit HS code and import duty for medical face masks
Correctly determining the HS code is a mandatory step in the medical face mask import procedure to apply the correct duty rate and management policy. Medical face masks mainly fall under the technical textiles category, classified according to material composition and actual intended use.
| Product Type | 8-Digit HS Code | Detailed Description | Import Duty (MFN) |
|---|---|---|---|
| Medical masks made of non-woven fabric | 6307.90.40 | Medical/surgical masks made of non-woven material, the most common type among imported medical masks | 0–5% |
| Dust filter/N95 masks for medical use | 6307.90.99 | Masks with a specialized filter membrane, meeting a higher bacteria/fine dust filtration standard than ordinary medical masks | 5–10% |
| Non-woven fabric material (raw material for mask production) | 5603.94.00 | Non-woven fabric in roll form, input material for mask manufacturing, imported separately from the finished product | 0–8% |
Important note on HS code and duty: HS code classification in the medical face mask import procedure must be based on the product’s physical composition and actual intended use, requiring careful cross-checking against the current export-import tariff schedule to apply the correct 8-digit code — this directly determines the duty payable. For goods with a valid C/O, such as Form E (China – ACFTA/RCEP), Form AI/AJ (ASEAN – Japan), or a CPTPP Form, import duty can drop to 0%. Businesses need to declare the correct intended use and product description to avoid a request for re-inspection or being routed to the red channel.
3. Documentation for the medical face mask import procedure
The documentation package for the medical face mask import procedure consists of two parts: legal documentation for the medical device, and standard customs documentation.
| Document | When to Prepare | Important Note |
|---|---|---|
| Sales Contract | Before placing a deposit | Must clearly state the mask type, technical standards, origin, and provision terms for the C/O and ISO 13485 |
| Commercial Invoice & Packing List | Before the goods are shipped | Must fully state the product name, packing specifications, and box/bale quantity for each type |
| Bill of Lading | After the goods are loaded onto the vessel | Medical masks are lightweight but bulky, so they are typically shipped as full container loads by sea, taking 4-7 days from nearby countries |
| Medical device classification document | Before the standard declaration | Confirms the medical mask is a Class A medical device — the basis for carrying out the applicable standard declaration |
| Applicable standard declaration documentation | Before the goods reach port (best done early) | Submitted to the Department of Health where the business is headquartered, together with the Letter of Authorization, ISO 13485, technical catalogue, and label sample |
| Letter of Authorization | Before the standard declaration | Mandatory if the importing entity is not the owner of the declaration number; should be consularly legalized to avoid complications |
| C/O (Certificate of Origin) | Before the goods are shipped | Form E, AI, AJ, CPTPP, etc., to enjoy special preferential import duty, which can drop to 0% |
| Electronic customs declaration (VNACCS/VCIS) | Once documentation is complete | Declare the correct HS code under heading 6307.90, noting the Declaration Receipt Form number and C/O number on the declaration |
4. Step-by-step medical face mask import procedure
Step 1: Determine the medical device classification
Confirm that the medical mask to be imported is a Class A medical device, and prepare the classification document as the basis for the subsequent applicable standard declaration step.
Step 2: Carry out the applicable standard declaration
Submit the applicable standard declaration documentation to the Department of Health where the business is headquartered, together with the Letter of Authorization, ISO 13485, technical catalogue, and label sample — best done before the goods reach port to avoid unnecessary storage and demurrage fees.
Step 3: Negotiate the contract and determine the HS code
Sign the contract to purchase medical masks, clearly stating technical standards and origin; correctly determine the HS code based on material composition and include the C/O requirement in the contract terms.
Step 4: Transport the goods to a Vietnamese port
Medical masks are typically shipped as full container loads by sea due to their lightweight but bulky nature; transit time from nearby countries is about 4-7 days.
Step 5: Customs declaration
Open the VNACCS/VCIS declaration with the complete HS code, the Declaration Receipt Form number, and the C/O number (if applicable). The system classifies the shipment into the green, yellow, or red channel; the yellow/red channel may require supplementary conformity certification or quality test reports.
Step 6: Pay duties, clear customs, and receive the goods
Once the documentation is accepted, pay the import duty and VAT to clear the declaration, and prepare the delivery order and pickup arrangements at port. After clearance, the goods can be transported to the warehouse, distributed to agents, or sold directly on the market.
5. How to calculate import duty for medical face masks
Medical face masks are not subject to special consumption tax, only import duty and the preferential 5% VAT rate for medical devices. For example, take a shipment of 3-layer medical masks imported from China (HS code 6307.90.40), with a CIF value of VND 250 million, comparing the case with and without a C/O Form E:
| Tax / Cost Item | No C/O (MFN 5%) | With C/O Form E (0%) |
|---|---|---|
| CIF Value | VND 250,000,000 | VND 250,000,000 |
| Import duty | 5% × 250M = VND 12,500,000 | 0% × 250M = VND 0 |
| VAT (5%, preferential medical device rate) | 5% × (250+12.5)M = VND 13,125,000 | 5% × (250+0)M = VND 12,500,000 |
| Total tax payable | VND 25,625,000 (~25.6 million) | VND 12,500,000 (~12.5 million) |
| Savings with a C/O | ~VND 13,125,000 — note the preferential 5% VAT rate specific to medical devices, significantly lower than the 10% rate applied to ordinary consumer goods. | |
From 3W Logistics’ real-world experience: With medical masks, the most common mistake we see is businesses applying the 10% VAT rate as if it were an ordinary consumer good, instead of the preferential 5% rate specific to medical devices, leading to miscalculated costs right from the import planning stage. In addition, many businesses wait until the goods reach port before starting the applicable standard declaration documentation, when it should instead be completed in parallel with shipping time to avoid unnecessary storage and demurrage fees. – Ms. Apple, CCO, 3W Logistics
6. Common risks in the medical face mask import procedure
| Risk | Manifestation | Prevention |
|---|---|---|
| Applicable standard declaration not yet completed | Goods arrive at port without a Declaration Receipt Form — the customs documentation is incomplete, incurring container/storage demurrage fees | Submit the applicable standard declaration documentation early, in parallel with the main shipment’s transit time |
| Confusion with ordinary cloth masks | Applying the medical device management procedure to everyday cloth masks, or vice versa — documentation rejected, delayed progress | Clearly determine the product’s intended use and technical standard before selecting the appropriate declaration procedure |
| Wrong HS code within heading 6307.90 | Confusion between ordinary medical masks and dust filter/N95 masks — customs reclassifies and collects the duty difference retroactively | Cross-check the technical catalogue and actual filtration standard before declaring the HS code; consult a forwarder experienced in medical device goods |
| Incorrect VAT rate applied | Calculating 10% VAT instead of the preferential 5% rate for medical devices — inaccurate import cost estimation | Confirm the correct HS code and the applicable preferential VAT scope before calculating shipment costs |
| Product label missing mandatory information | The original label lacks sufficient Vietnamese content under Article 54 of the medical device management Decree — customs holds the goods and requests a supplementary label at the port | Prepare a complete supplementary label sample per regulations before the goods reach port |
FAQ – Frequently asked questions about the medical face mask import procedure
Question 1: What documents does the medical face mask import procedure require?
The complete documentation package for the medical face mask import procedure includes: the Sales Contract; Commercial Invoice and Packing List; Bill of Lading; C/O (if seeking FTA preference); the medical device classification document; the applicable standard declaration Receipt Form; a Letter of Authorization (if needed); ISO 13485; and the VNACCS/VCIS electronic customs declaration.
Question 2: Does importing medical face masks require an import license from the Ministry of Health?
No. As of January 1, 2018, the Class A medical device import license was fully replaced by the applicable standard declaration procedure at the local Department of Health. This is an important point to be aware of when carrying out the medical face mask import procedure, significantly shortening the process compared to the previous license-application procedure.
Question 3: How many types of tax must be paid when importing medical face masks?
Medical face masks are subject to only two layers of tax: (1) Import duty, calculated on the CIF value, ranging from 0-10% under MFN depending on the type, which can drop to 0% with a valid FTA C/O (Form E, AI, AJ, CPTPP, etc.); and (2) VAT at a preferential 5% rate specific to medical devices, lower than the 10% rate for ordinary consumer goods. Medical face masks are not subject to special consumption tax.
Question 4: How long does the medical face mask import procedure take?
The total time from the applicable standard declaration to the goods arriving at the warehouse is typically 15-30 days. Within this: the applicable standard declaration at the Department of Health is usually processed quickly if the documentation is complete; transport from China/Asia takes 4-7 days; and customs declaration and clearance take 1-3 days for the green channel, longer if routed to the yellow/red channel requiring supplementary documentation.
How does 3W Logistics support the medical face mask import procedure?
With experience handling a wide range of imported medical devices and medical supplies, and registered as an OTI-NVOCC with an FMC bond (Federal Maritime Commission) in the United States, 3W Logistics provides a full-package service for businesses on the medical face mask import procedure — from standard declaration advisory through to the goods arriving at the distribution warehouse.
Full-package logistics service at 3W Logistics:
- Advisory on medical device classification and the applicable standard declaration: Correctly determining that the medical mask is a Class A device, and preparing complete declaration documentation at the Department of Health from the earliest stage.
- Accurate HS code determination by product composition: Correctly classifying between ordinary medical masks and dust filter/N95 masks, avoiding the risk of reclassification and retroactive tax collection.
- Calculating actual duty including the preferential 5% VAT rate: Helping businesses arrive at an accurate cost figure before contract negotiation.
- Support obtaining the correct FTA-form C/O from the supplier: Guiding Chinese suppliers in applying for Form E, and Japanese suppliers in applying for Form AJ/CPTPP, to optimize import duty costs.
- Electronic customs declaration via VNACCS/VCIS and resolving issues at the border: Declaring the correct HS code, coordinating to submit standard declaration documentation on time.
Why choose 3W Logistics for your medical face mask import shipment? The medical face mask import procedure requires a clear understanding of Class A medical device regulations, accurate HS code classification, and correct application of the preferential VAT rate. We stand alongside you from the applicable standard declaration step through to the goods arriving at the warehouse — helping your business shorten customs clearance time and avoid unnecessary additional costs. Contact 3W for specific advice before signing your import contract.
Address: 34 Bach Dang, Tan Son Hoa Ward, Ho Chi Minh City
Hotline: +84 28 3535 0087
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3W Logistics Hanoi Branch
Address: 81A Tran Quoc Toan, Cua Nam Ward, Hanoi
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3W Logistics Hai Phong Branch
Address: 8A Lot 28 Le Hong Phong, Gia Vien Ward, Hai Phong
Hotline: +84 225 355 5939
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3W LOGISTICS CO., LTD – We here serve you there!
Email: info@3w-logistics.com
Website: www.3w-logistics.com
Ms. Apple is the CCO (Chief Commercial Officer) at 3W Logistics, with over 10 years of experience in sales and business operations management.
At 3W Logistics, Ms. Apple is responsible for commercial strategy, corporate customer development, managing a team of more than 50 sales professionals, and improving business performance in the logistics sector.
With practical experience in sales management and market development, Ms. Apple shares professional insights on business logistics solutions, international transportation, freight forwarding, customer management, trade lane development, and growth strategies in the logistics industry.
