Medical device export procedures in Vietnam are built on a more streamlined set of principles compared to import procedures, though businesses are still required to fully comply with regulations on risk classification, traceability, and the specific requirements of each destination market.
The current legal framework has been continuously updated through Decree 98/2021/ND-CP, Decree 07/2023/ND-CP, Decree 96/2023/ND-CP, and most recently Decree 04/2025/ND-CP, effective from January 1, 2025, along with Circular 19/2024/TT-BYT, which issued a dedicated HS code list for import/export medical devices.
Vietnam’s medical device manufacturing industry is increasingly diverse, ranging from consumables and basic medical instruments to diagnostic imaging equipment and high-tech devices, creating significant opportunities to expand into export markets. The article below compiles the legal basis, conditions, HS codes, procedures, costs, and common risks involved in medical device export procedures, updated according to the latest applicable regulations.
1. Special characteristics of medical device export procedures
Unlike imports — which are tightly controlled to protect domestic consumers – medical device exports are carried out on the principle that businesses take full responsibility for the quality, quantity, type, and intended use of the products they export, while also complying with general import-export law under Article 46 of Decree 98/2021/ND-CP.
The key point in medical device export procedures lies in the risk classification stage — a mandatory step that forms the foundation for a domestic manufacturer’s entire legal documentation, regardless of whether the final purpose is domestic consumption or export abroad.
2. Legal basis governing medical device export procedures
| Legal document | Content regulated |
|---|---|
| Decree 98/2021/ND-CP | The foundational regulation on medical device management, principles for import/export (Article 46), and risk classification (Appendix I) |
| Decree 07/2023/ND-CP, Decree 96/2023/ND-CP | Amends and supplements several articles of Decree 98/2021/ND-CP, adjusting related administrative procedures |
| Decree 04/2025/ND-CP (effective January 1, 2025) | The latest update, adjusting cases where a separate specialized license is not required if the device has already been classified and publicly disclosed |
| Circular 19/2024/TT-BYT | Issues the list of export/import medical devices with determined HS codes |
| Circular 38/2015/TT-BTC, amended by Circular 39/2018/TT-BTC | Customs procedures and supervision for exported goods |
This is the fundamental legal framework that businesses need to understand clearly in order to correctly carry out medical device export procedures, avoiding confusion between regulations designed for export versus import.
3. Conditions and classification of medical devices before export
| Classification group | Risk level | Note |
|---|---|---|
| Class A | Low risk | Only requires a declaration of applicable standards; no circulation number needed |
| Class B | Low to medium risk | Requires registration of a circulation number for domestic trading and manufacturing |
| Class C | Medium to high risk | Requires registration of a circulation number, with more detailed technical documentation |
| Class D | High risk | Requires registration of a circulation number, the strictest control among the four groups |
Practical note: The medical device classification result under Appendix I of Decree 98/2021/ND-CP is the first and mandatory step, forming the basis for a domestic manufacturer’s entire legal documentation. From 2025, the Ministry of Health has strengthened post-market inspection, requiring classifying facilities to periodically update data on the electronic system; businesses need to ensure the classification currently in use remains valid before proceeding with medical device export procedures.
4. Medical device HS codes under Circular 19/2024/TT-BYT
Medical devices mainly fall under Chapter 90 – “Optical, photographic, cinematographic, measuring, checking, precision, medical or surgical instruments and apparatus” – although some consumables and plastic instruments used in healthcare may fall under other chapters. Correctly determining the HS code according to the list established by the Ministry of Health in medical device export procedures helps businesses avoid declaration errors.
| Product type | HS code (Vietnam) | Vietnam export duty | Note |
|---|---|---|---|
| Diagnostic imaging instruments/equipment (ultrasound, X-ray) | 9018.12/9022.xx | 0% | Classified as high-tech equipment, usually Class C or D |
| Handheld medical/surgical instruments | 9018.90 | 0% | Applies to surgical scissors, medical forceps, and similar instruments |
| Medical consumables (syringes, medical gloves) | 9018.31/4015.12 | 0% | Vietnam’s most common export product group |
| Medical furniture (hospital beds, operating tables) | 9402.xx | 0% | Classified as furniture used specifically for medical and surgical purposes |
Practical note: Export duty on medical devices in Vietnam is currently 0% for most HS codes under Chapter 90. Businesses should directly cross-check the HS code list established by the Ministry of Health in Circular 19/2024/TT-BYT to avoid confusion between product groups with similar functions but different codes.
5. Documentation package for medical device export procedures
| Document | When to prepare | Important note |
|---|---|---|
| Medical device classification result | Before manufacturing/exporting the first shipment | Issued by a facility publicly listed by the Ministry of Health, must remain valid at the time of export |
| Certificate of Free Sale (CFS) | As required by the importing country | Many markets require this to prove the product is legally circulated in Vietnam |
| ISO 13485 certification (medical device quality management system) | Before signing a contract with a demanding market | An almost mandatory condition for the EU, the U.S., and many other developed markets |
| Commercial contract, invoice, packing list | Before customs declaration | Value must match the bill of lading; must clearly state product technical standards |
| Certificate of Origin (C/O) | After the export declaration is issued | Required to enjoy preferential tariffs under the relevant FTA for the destination market |
| Export customs declaration (VNACCS) | Before customs clearance | Declare the correct HS code according to Circular 19/2024/TT-BYT |
6. Medical device export procedure steps
Step 1: Complete the medical device classification documentation
The manufacturer coordinates with a classifying facility publicly listed by the Ministry of Health to obtain a Classification Result according to risk level (A, B, C, D) — this is the mandatory legal foundation before proceeding with the subsequent steps of medical device export procedures.
Step 2: Apply for a Certificate of Free Sale (CFS) if required by the importing country
For markets that require proof the product is legally circulated in Vietnam, the business submits a CFS application to the competent authority, which typically takes 5-7 working days.
Step 3: Standardize the quality management system to meet the destination market’s standards
The business pursues international certifications such as ISO 13485, CE marking (EU market), or FDA registration (U.S. market), depending on the specific requirements of the importing customer.
Step 4: Sign the contract and manufacture according to the order
Manufacture and package the product according to the technical standards agreed with the importer, ensuring consistency with the classification documentation and quality certifications already obtained.
Step 5: Complete the documentation package and declare customs export
The enterprise or its forwarder prepares the invoice and packing list, and declares the electronic customs declaration on the VNACCS system, attaching the CFS (if applicable), quality certifications, and a C/O matching the FTA of the destination market.
Step 6: International transport and import clearance in the destination country
Once the declaration is cleared, the goods are handed over to a sea or air carrier depending on the nature of the product. The importer coordinates with the local pharmaceutical/medical device regulatory authority to complete the import procedures.
7. Timeline and costs in medical device export procedures
| Stage | Estimated time | Note |
|---|---|---|
| Medical device classification (if not yet done) | 1 – 2 weeks | Done once for each product line |
| Applying for a Certificate of Free Sale (CFS) | 5 – 7 working days | Only applicable when required by the importing country |
| Export customs declaration (VNACCS) | 0.5 – 1 day | Faster if the declaration is routed to the green channel |
| Sea/air transport | 3 – 30 days | Depending on the destination market and mode of transport |
Practical note: Businesses should fully prepare classification documentation and international quality certifications before signing a contract, to avoid waiting periods that affect delivery schedules in medical device export procedures, especially for demanding markets such as the EU and the U.S.
8. Common risks in medical device export procedures
| Risk | Manifestation | Prevention |
|---|---|---|
| Classification result expired or invalid | CFS documentation or export rejected | Periodically check the Ministry of Health’s electronic system as required since 2025 |
| Incorrect HS code under Circular 19/2024/TT-BYT | Retroactive tax collection, delayed customs clearance, need to amend the declaration | Carefully cross-check the HS code list with a customs unit experienced in medical device shipments |
| Missing ISO 13485/CE certification required by the market | Goods rejected for import despite having cleared customs in Vietnam | Confirm each market’s specific certification requirements before signing the contract |
FAQ – Frequently asked questions about medical device export procedures
Question 1: Does exporting medical devices require a specialized license like importing does?
Not exactly the same. Exports are carried out on a principle of business self-responsibility, and a specialized license is not mandatory as it is for imports; however, a Classification Result is still required, along with compliance with the specific requirements of the importing country.
Question 2: What is the current export duty on medical devices in Vietnam?
Medical devices under Chapter 90 enjoy a 0% export duty rate in Vietnam according to the HS code list established in Circular 19/2024/TT-BYT.
Question 3: What does a business need to prepare to export to the EU or the U.S.?
Businesses should obtain ISO 13485 certification, meet CE marking standards (EU), or complete FDA registration (U.S.), in addition to the Classification Result and CFS as required by each specific market.
How does 3W Logistics support medical device export procedures?
As a freight forwarding company registered as an OTI-NVOCC with an FMC bond in the United States, holding an SCAC Code to self-file AMS/ISF declarations directly, 3W Logistics supports businesses through the entire medical device export procedure — from HS code advisory and coordinating CFS applications through to customs clearance in the importing country.
Full-package logistics service at 3W Logistics:
- HS code advisory and export conditions by market: Accurately cross-checking the Circular 19/2024/TT-BYT list, advising on each country’s specific certification requirements.
- Booking vessels and multimodal transport: Arranging sea or air transport suited to the nature of medical devices.
- Electronic customs declaration (VNACCS): A professional team handles declarations, directly issues its own HBL, and self-files AMS/ISF for shipments bound for the U.S. as an OTI-NVOCC with FMC and an SCAC Code.
Why choose 3W Logistics: With offices in Ho Chi Minh City, Hanoi, and Hai Phong, and a team knowledgeable in medical device regulations that stays continuously updated, 3W Logistics ensures shipments clear customs on time and to standard, right from the very first export. – Ms. Apple, CCO of 3W Logistics
Head Office – 3W Logistics Ho Chi Minh City Branch
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
Hotline: +84 24 3202 0482
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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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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.
