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IMPORT PROCEDURE GUIDE FOR FOODS FOR PATIENTS
Foods for patients carry higher compliance risk than ordinary processed foods because the product usually includes specific target users, directions for use, specialized nutrition composition and claims linked to medical conditions. Misapplied HS code, confusion between self-declaration and product declaration registration, incomplete food safety dossier or inconsistent labels may delay clearance and increase logistics cost. This guide provides an E2E review map before ETA.
QUICK FACTS
Product
Foods for patients in powder/liquid/can/bottle/sachet form for specific dietary or medical nutrition use.
Key HS
Heading 1901 medical foods; review 1901.90.39.10, 1901.90.90.10/1901.90.91 or 2106 by dossier.
Reference duty
Medical foods under heading 1901 often show MFN 7–10%, ordinary 10.5–15%, standard VAT 10%; FTA may be 0–5% with valid C/O.
Key policy
Product declaration registration; state food safety inspection on import; labeling/instructions; medical-claim control.
Technical file
Formula, nutrition facts, target users, directions, COA/test report, original label, CFS if any.
Caution
Do not treat automatically as ordinary food or health supplement; review claims, users and actual form.
Legal note: This article applies only to foods for patients within the group medical nutrition, meal replacements and foods for special dietary uses. It does not automatically apply to medicines, health supplements, infant formula, ordinary meal replacements or manufacturing ingredients. Review ingredients, claims, target users, product form, label, COA/test report and product declaration registration certificate.
SCOPE OF APPLICATION
This guide covers foods designed for the dietary management of patients or people with special nutritional needs, in powder, liquid, can, bottle, sachet or box form, containing protein, carbohydrates, fats, vitamins, minerals, fiber, MCT, peptides, amino acids or other specialized nutrients.
- Do not automatically apply to medicines, health supplements, ordinary fortified products, infant formula, weight-control meal replacements or treatment-claim products.
- If the product is for children, elderly users, diabetic patients, renal patients, oncology patients or tube feeding, review target users, directions, warnings and declaration dossier separately.
- Samples, hospital goods, donations, R&D goods, project cargo or EPE/FDI imports may require different customs regimes and circulation documents.
CLASSIFICATION & TECHNICAL IDENTIFICATION
The key decision is whether the product is medical nutrition: whether it is for patients, whether medical supervision is expected, whether the nutrition profile is specialized and whether label claims describe dietary management rather than disease treatment.
| Checkpoint | Documents to review | Risk if described incorrectly | Suggested goods description |
|---|---|---|---|
| Product nature | Specification, catalogue, original label, directions | Confusion with ordinary food, supplement or medicine | Food for patients/medical food, form…, intended for…, not medicine |
| Product form | Photos, packing list, packing spec | Confusion among powder, RTD liquid, cans/bottles or ingredients | Powder/liquid ready-to-use, packed…, net weight/volume… |
| Ingredient base | Ingredient list, nutrition facts, formula | Wrong HS between dairy, cereal, soy, peptide or other preparations | State dairy/non-dairy base and protein/carbohydrate source if needed |
| Target users | Label, leaflet, directions, declaration dossier | Wrong route if for children or disease-specific users | For dietary management of patients; target user… |
| Claims/warnings | Artwork, website, marketing material | Treatment claims may create medicine/advertising risk | Do not state therapeutic effects; follow registered dossier |
HS CODE – DUTY – C/O
Foods for patients are often reviewed under heading 19.01 where they are food preparations based on flour, cereal, malt extract, milk or goods of headings 04.01–04.04 and classified as medical foods. If not classifiable under 1901, heading 2106 or another heading may need review.
| Reference HS | Application condition | Ordinary duty | MFN duty | VAT | FTA preference | Risk if incorrect | Documents |
|---|---|---|---|---|---|---|---|
| 1901.90.39.10 | Medical foods under goods of headings 04.01–04.04; often dairy-based products | 15% | 10% | 10%; possibly 8% if VAT reduction applies | 0–5% under some FTAs with valid C/O | May be challenged if non-dairy/supplement/medicine/ingredient | Specification, ingredients, label, COA, declaration, C/O |
| 1901.90.90.10 / 1901.90.91 | Other medical foods under current tariff structure | Check at declaration date, often 0–15% | Check at declaration date, often 0–10% | 10%; review VAT reduction | By FTA and C/O | Outdated/non-matching subheading causes duty/C/O risk | Formula, base ingredients, form, label, declaration |
| 1901.10.20.10 / 1901.10.90.10 | Only for infant/young-child preparations classified as medical foods | 10.5–15% by subheading | 5–10% by subheading | 10%; review VAT reduction | May be 0–5% | Using infant lines for adult products is incorrect | Age range, label, directions, formula |
| 2106.90.xx | Only if not classifiable in 1901 and not specified elsewhere | Final HS | Final HS | Final HS | By eligible FTA | Confusing medical food with supplement/medicine affects declaration and labels | Formula, claims, dossier, COA |
C/O note: Incorrect C/O form, origin criterion, goods description, HS code or transport evidence may lead to denial of special preferential duty.
APPLICABLE SPECIALIZED POLICY
| Goods scenario | Possible policy | Documents to check | Authority/channel | Timing | Risk note |
|---|---|---|---|---|---|
| Commercial import | Product declaration registration; import food safety inspection; label; claim control | Registration certificate, test report, label, COA, specification | Food safety authority; Customs; DVC/NSW if applicable | Before contract and ETA | Do not process as ordinary food self-declaration if registration applies |
| Medical food / for patient labeling | Review function, target users, directions and warnings; avoid medicine presentation | Leaflet, label, declaration dossier, nutrition data | Food safety authority | Before label printing and ETA | Treatment claims may cause rejection or advertising risk |
| Products for children | Separate rules may apply to child nutrition products, labels and advertising | Label, age range, directions, formula | Competent food safety authority | Before import | Do not combine adult and child products |
| Liquid/cold-chain goods | Review transport temperature, shelf-life and food-contact packaging | Temperature log, COA, label, storage condition | Customs, food safety authority, cold-chain provider | Before booking/ETA | Temperature errors may affect quality/shelf-life |
| Samples/R&D/hospital use | Different customs regime and purpose evidence may apply | Purpose letter, PO, quantity, product docs | Customs and specialized authority if requested | Before declaration | Do not use sample route for disguised commercial import |
LEGAL DOCUMENTS TO REVIEW
| Document group | Document name/number | Issuing authority | Effective timing | Role | Key points | Review note |
|---|---|---|---|---|---|---|
| Law | Food Safety Law 55/2010/QH12 | National Assembly | From 01 Jul 2011 | Basis for imported food safety, storage, labeling and traceability | Trader responsibilities, storage, labeling, traceability | Check amendments |
| Food safety decree | Decree 15/2018/ND-CP | Government | From 02 Feb 2018 | Product declaration registration, import inspection, labeling and advertising | Article 6; Articles 7–8; import inspection | Medical nutrition/special diet products need registration review |
| Validity status | Decree 46/2026/ND-CP and Resolution 15/2026/NQ-CP | Government | Resolution 15 effective 06 Apr 2026 and suspends Decree 46 and Resolution 66.13/2026 | Monitor applicable food safety regime | Suspension status | Do not present Decree 46 as applicable without rechecking |
| Circular/consolidated | Circular 43/2014/TT-BYT; consolidated 11/VBHN-BYT | Ministry of Health | Check at application date | Management of functional foods, medical foods and special dietary foods | Classification, labeling, directions, declaration | Apply by actual product scope |
| Nutrition labeling | Circular 29/2023/TT-BYT | Ministry of Health | From 15 Feb 2024 | Nutrition facts and nutrition value labeling | Nutrition declaration content | Important for energy/protein/vitamins/minerals |
| Goods labeling | Decrees 43/2017 and 111/2021 | Government | 01 Jun 2017 / 15 Feb 2022 | Original and Vietnamese supplementary labeling | Name, quantity, ingredients, expiry, origin, warnings | Must match declaration dossier |
| Tariff | Decrees 26/2023 and 108/2025 | Government | 15 Jul 2023 / 19 May 2025 | MFN tariff and Chapter 19/21 structure | Codes 1901/2106 | Check at declaration date |
| VAT | VAT Law 48/2024; Decree 181/2025; Resolution 204/2025; Decree 174/2025 | National Assembly/Government | From 01 Jul 2025 for key texts | Standard VAT and 2% reduction if eligible | Exclusions and effective period | Check before VAT declaration |
VIEW / DOWNLOAD ORIGINAL LEGAL TEXTS
Decree 15/2018/ND-CPResolution 15/2026/NQ-CPCircular 29/2023/TT-BYTConsolidated text 11/VBHN-BYTChapter 19 tariff reference
Enterprises should cross-check on official legal document portals or issuing authority websites before application.
CUSTOMS CLEARANCE DOCUMENT SET
Commercial documents
- Commercial Invoice
- Packing List
- Bill of Lading/Air Waybill
- Sales Contract/Purchase Order
- C/O
- Catalogue/specification, original label, photos
Food safety / declaration files
- Product declaration registration certificate
- Product declaration form
- Test report / COA
- CFS if any
- Supplementary label and directions
Shipment control data
- Ingredients and nutrition facts
- Target users and warnings
- Batch/MFG/EXP
- Storage condition
- Packing specification
| File group | Documents | Used for | Prepared by | Common error | Pre-ETA check |
|---|---|---|---|---|---|
| Commercial | Invoice, Packing List, Contract/PO | Value, quantity, trade terms | Procurement/Docs/Importer | Generic name, missing form | Match SKU, net weight/volume, packing and label |
| Transport | B/L or AWB, arrival notice, pre-alert | D/O, manifest, declaration | Forwarder/Carrier/Docs | Wrong consignee/description/packages | Review draft B/L/AWB |
| HS–tax | Specification, ingredients, formula, label | HS, MFN, VAT, FTA | Importer/Compliance/Broker | Confusing 1901, 2106, supplement or medicine | Prepare product nature analysis |
| Declaration/FS | Registration certificate, test report | Food safety inspection and circulation | Importer/QA/Compliance | Using self-declaration instead of registration | Match name, ingredients, criteria, labels and certificate |
| C/O | Eligible C/O, invoice, transport docs | Special preferential duty | Exporter/Supplier/Docs | Wrong HS/description/origin criterion | Check draft before ETA |
| Label/instructions | Original label, supplementary label, leaflet, artwork | Post-clearance circulation | Importer/Marketing/Compliance | Missing warning/users/directions/expiry | Review under labeling and declaration rules |
DECISION POINTS THAT MAY HOLD THE SHIPMENT
| Decision point | Question | Evidence | Consequence | Recommended action |
|---|---|---|---|---|
| Product nature | Food for patients, medical nutrition, supplement, medicine or ordinary food? | Specification, label, declaration dossier | Wrong declaration route, HS and delay | Finalize legal classification before contract |
| HS code | Heading 1901 medical food or 2106 preparation? | Formula, base ingredients, form, tariff | HS query, duty correction, C/O error | Prepare HS analysis |
| Declaration registration | Valid registration certificate? | Certificate, declaration, test report | Insufficient circulation basis | Check before ETA |
| Label and claims | Treatment claims beyond dossier? | Artwork, leaflet, website, label | Label remediation, medicine/advertising risk | Lock label by dossier |
| Food safety inspection | Which inspection mode applies? | Shipment docs, import history, certificate | Delay, sampling, storage | Determine before ETA |
| C/O | Correct form, HS, description, origin and direct transport? | Draft C/O, invoice, B/L | Loss of preference | Review draft before arrival |
PRACTICAL E2E WORKFLOW
Pre-ETA review.
Finalize product classification, HS, duty, VAT, C/O, declaration registration, label, food safety inspection and storage condition.
Lock documents and product dossier.
Finalize Invoice, Packing List, B/L/AWB, specification, formula, nutrition facts, test report, declaration certificate and labels.
Register/check specialized dossier.
Key controls include product declaration registration certificate and import food safety inspection dossier.
Lodge customs declaration.
Green, Yellow and Red channels may apply depending on system risk and dossier review.
Clear, deliver and archive records.
Control supplementary labels, retain declaration, test results, C/O and transport documents.
PRE-ETA RISK CHECKLIST
| Risk | Consequence | Pre-ETA prevention | Documents |
|---|---|---|---|
| Confusing self-declaration with registration | Insufficient circulation basis and delay | Classify as medical nutrition before import | Decree 15, certificate, label, specification |
| Generic goods name | Wrong HS and food safety policy | State medical food/food for patients, form and users | Invoice, catalogue, label, formula |
| Label-test-declaration mismatch | Explanation or amendment required | Lock label and formula before testing/declaration | Label, test report, dossier |
| Treatment claims | Medicine/advertising compliance risk | Review claims, leaflet and website | Artwork, directions, marketing |
| Wrong C/O HS/description | FTA duty denied | Check C/O against invoice, B/L and expected HS | C/O, invoice, B/L |
| No shelf-life/temperature control | Quality/storage cost risk | Check expiry, remaining shelf-life and cold chain | COA, label, packing, booking note |
FAQ
| Question | Short answer |
|---|---|
| Does importing foods for patients require a permit? | Do not treat it as a generic permit. Key requirements are often declaration registration, food safety inspection, labeling and customs dossier. |
| Can it be self-declared like ordinary food? | Do not assume so. Medical nutrition and special dietary foods usually require product declaration registration under Decree 15/2018. |
| Which HS code is commonly used? | Review heading 1901 medical foods such as 1901.90.39.10 or other 1901 medical food lines; if nature differs, review 2106/other headings. |
| Is food safety inspection required? | It may be required depending on dossier, compliance history and inspection mode. |
| Is Vietnamese supplementary labeling required? | Yes, if circulated in Vietnam; it must match declaration dossier and original label. |
| Can C/O reduce duty? | Potentially, if C/O form, origin criterion, description, HS and transport comply with the FTA. |
| What if label says for diabetic patients? | Review as disease-specific dietary management; claims, directions and declaration dossier must be consistent. |
| Are hospital/R&D samples like commercial goods? | Not always; review purpose, quantity, value and circulation intention. |
NEED TO REVIEW IMPORT PROCEDURES OR A SHIPPING PLAN?
Send us the product name, shipping route, current dossier, or implementation request in advance so we can suggest a suitable approach that is practical, focused, and aligned with your shipment.
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