A foreign brand’s first Vietnamese dossier tends to fail in one of two ways. It is built against the wrong instrument, or it takes the lighter of the two declaration routes for a product that sits in the pre-approval category, where goods may not circulate until a certificate has been issued. Vietnamese law sorts food by a closed list, not by what the product is called at home.
Which decree your dossier is built to
Build to Decree 15/2018/ND-CP (Nghị định 15/2018/NĐ-CP in the Vietnamese text) — the decree written to replace it, Decree 46/2026/ND-CP, has been suspended since shortly after it was issued and has never taken effect.
| Date | Instrument | Effect |
|---|---|---|
| 26/01/2026 | Decree 46/2026/ND-CP | Issued to guide the Law on Food Safety, replacing Decree 15/2018/ND-CP |
| 04/02/2026 | Resolution 09/2026/NQ-CP | Suspended Decree 46/2026 to the end of 15 April 2026 |
| 06/04/2026 | Resolution 15/2026/NQ-CP | Replaced Resolution 09/2026 and continued the suspension — by condition, not by date |
Checked against the published texts on 15 September 2026.
The last row is what most English pages miss. Resolution 09/2026 set a fixed end date of 15 April 2026, which is why anything written before 6 April 2026 says the suspension lapsed that day. Resolution 15/2026 replaced it and tied the suspension to a condition instead — it runs until the amended Law on Food Safety and its guiding decree take effect — and provides that dossiers already filed continue under Decree 15/2018. There is no date to wait for, so build to Decree 15/2018 and record which instrument you filed against and when.
💬 Not sure which side of the line your product falls on? Send us the ingredient list and the label artwork and we will tell you the route before you commit to anything — contact Sunsho Trade.
Start here — five questions in order
Work down these five questions and stop at the first one you can answer yes to, because that answer is your route.
1. Is the product, or the raw material, used only to make goods for export, or only for your own internal production, and never sold on the Vietnamese market? Then Article 4 clause 2 exempts it from the self-declaration procedure altogether. The exemption is narrow: the moment any of the same stock is sold domestically, it stops covering it.
2. Is it a health supplement (thực phẩm bảo vệ sức khỏe), a medical nutrition food, or a food for a special dietary use? Registered declaration — Article 6 clause 1. These cannot be self-declared.
3. Is it a nutrition product for children up to 36 months of age? Registered declaration — Article 6 clause 2.
4. Is it a mixed food additive with a new use, an additive not on the Ministry of Health’s permitted list, or an additive used outside the use permitted for it? Registered declaration — Article 6 clause 3.
5. None of the above, and it is a processed pre-packaged food, a food additive, a food processing aid, a food container or utensil, or a packaging material in direct contact with food? Then it self-declares under Article 4 clause 1, which covers exactly that list “except products specified in clause 2 of this Article and Article 6 of this Decree”.
Self-declaration (tự công bố) is not a category you qualify for. It is what is left once Article 6 has taken what it names, so the route turns on one question: does Article 6 reach your product? Article 5 clause 2 lets you produce and trade immediately after a self-declaration, whereas on the registered route nothing may be sold until a certificate of receipt of product declaration registration (Giấy tiếp nhận đăng ký bản công bố sản phẩm) has been issued.
The trap — your home-market category does not travel
A product that is an ordinary food at home can land in Vietnam’s pre-approval category, because Article 3 clause 1 classifies by composition, by dosage form and by stated purpose — and the purpose is whatever you printed on the label.
Article 3 clause 1 defines a health supplement as a product used to supplement the daily diet in order to maintain, enhance or improve the functions of the human body, or to reduce the risk of disease. The same clause narrows by composition — vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other bioactive substances — and by presentation, listing capsules, pills, tablets, granules, powder and liquid.
A collagen jelly, a vitamin drink, a protein powder or a herbal sachet can each sit in ordinary retail at home and still meet all three limbs here. A functional statement on the front of the pack is not decoration. It is classification evidence.
Health supplements are foods, not medicines, and are not a substitute for medical treatment. If your artwork names an illness or says the product acts on one, it has to come off before the dossier is built, because Article 7 requires scientific evidence for the function claimed. Every extra document Article 6 brings with it is issued by somebody else, which is why the route has to be settled before artwork and before the first purchase order. The Vietnamese supplementary label checklist covers the sub-label.
💬 We check the route for your specific product before anything ships, as part of our market-entry service — importer of record, dossier and labelling under one line of responsibility.
Who files, and who the certificate belongs to
Article 2 applies Decree 15/2018 to Vietnamese organisations and individuals and to foreign organisations and individuals in Vietnam engaged in producing or trading food, so the declaration is filed by a party established here — and the certificate is issued in that party’s name, not the brand’s.
That party is usually the importer or the appointed distributor. The certificate is issued to a named organisation and does not travel with the product. Change the organisation responsible for placing the goods on the market — a new importer of record, say — and the incoming one registers its own declaration under Articles 6 to 8, building the file again from the start. Change a distributor further down the chain, with the holder unchanged, and no procedure arises.
So the distribution agreement has three things to settle before the dossier is filed. Who is named as declaration holder. Whether the manufacturer’s documents may be used by a successor. And what happens on termination, because a certificate standing in a former partner’s name does not come with you.
Where the dossier goes
Under Article 8 clause 1, health supplements and the food additives caught by Article 6 clause 3 go to the Ministry of Health, while medical nutrition foods, foods for special dietary uses and nutrition products for children up to 36 months go to a body designated by the provincial People’s Committee.
That is not the whole picture today. Decree 148/2025/ND-CP of 12 June 2025 took effect on 1 July 2025 and decentralised the registration procedure for those three provincial categories to the provincial health authority. On our reading its Article 28 does not extend to health supplements, which stay with the Ministry of Health — confirm that against the current text, and confirm the receiving body when you file. Decree 148/2025 is itself written to expire on 1 March 2027 unless extended.
A self-declaration is not submitted for approval at all. Under Article 5 clause 2 point a, as amended by Decree 155/2018/ND-CP, the company publishes it on mass media, on its own website or on a notice at its premises, and on the national food-safety data system; where that system is unavailable, one copy goes to the provincial-designated body to be held on file.
What each route has to file
A self-declaration is built on a declaration form and a test report, while a registration dossier adds evidence for the function, a GMP certificate and, on imports, a certificate from the authority of the country of origin.
| Document | Self-declaration | Registered — imported | Registered — made in Vietnam |
|---|---|---|---|
| Declaration form (Annex I) | Form 01 | Form 02 | Form 02 |
| Food-safety test report, within 12 months to submission, from a designated laboratory or one accredited to ISO 17025 | Required | Required | Required |
| Scientific evidence for the function claimed on the label | — | Required | Required |
| Certificate of Free Sale, Certificate of Exportation or Health Certificate from the competent authority of the country of origin or export | — | Required | — |
| GMP certificate for the manufacturing site | — | For health supplements — or an equivalent certificate (Article 7 clause 1) | For health supplements — no equivalent-certificate option (Article 7 clause 2) |
| Certificate of establishment eligible for food safety | — | — | Required where the establishment is subject to it |
| Foreign-language documents translated into Vietnamese and notarised | Required | Required | Required |
Three rows are worth reading closely.
The test report window runs to the date of submission, not to the date the sample went to the laboratory, so a report commissioned early in a long negotiation can fall outside it.
The foreign certificate has to arrive authenticated in the form the receiving body accepts, and that form changed on 11 September 2026, when the 1961 Hague Apostille Convention entered into force for Vietnam. Settle it per document and per country before you send an original abroad — our note on apostille or consular legalisation sets out the four routes and which states still need the embassy.
The establishment certificate has an exemption most domestic producers can use. Article 12 clause 1 point k exempts an establishment already holding a valid GMP, HACCP, ISO 22000, IFS, BRC or FSSC 22000 certificate, or an equivalent.
💬 Working out the route for a product you have not shipped yet? Sunsho Trade is a Japanese-managed trading company in Ho Chi Minh City. We can act as importer of record, prepare and submit the dossier your category requires. Tell us about your product.
What sends a dossier back
In the dossiers we handle, an amendment request points at one of five documentary failures, and three of the five turn on paperwork the manufacturer issues rather than on anything the brand owner can correct alone.
Test coverage. A report that omits an indicator the applicable QCVN requires is short, however good the laboratory. Build the indicator list from the regulation and from the specification you are declaring, then test the gap.
Disagreement between label, composition table and test report. Ingredient names, quantities and units have to read identically in all three, and this group recurs because people correct one document and leave the other two.
The laboratory itself. Article 7 clause 1 requires a designated laboratory or one accredited to ISO/IEC 17025, so saving money here buys a second round of testing.
Evidence that does not match the claim. Article 7 requires evidence for the function declared, on the right active substance at the right level of use. Where it falls short, dropping the claim is faster than finding better evidence.
The form of the foreign documents. The free-sale and GMP certificates have to be authenticated by the route the issuing country’s status requires, and both must still be valid on the submission date, not on the date the factory sent them.
Only the second and fourth are yours to fix without waiting on someone else, which makes a manufacturer’s document capability a schedule risk. Under Article 8 clause 3 a receiving body may require amendment once only, so the first submission is the one worth getting right.
Keeping a declaration alive
A change to the product name, the origin or the composition means declaring again on either route, while other changes are notified in writing.
The rule is written twice, once for each route — Article 5 clause 4 for self-declaration, Article 8 clause 4 for registered declaration.
Decree 15/2018 sets no expiry date for the certificate, which is not the same as permanence: a reformulation can trigger a fresh declaration, a product in breach can have its certificate withdrawn, and a change of holder means a new registration. Read “no expiry date” as “no renewal reminder” and put the review in your own calendar.
Sources on the Government’s legal portal — Decree 15/2018/ND-CP, Resolution 15/2026/NQ-CP and Decree 148/2025/ND-CP. Requirements differ by category and change over time, so confirm the current text before you rely on it. Not legal advice.
Frequently asked questions
1. Can a health supplement ever be self-declared in Vietnam?
No. Article 6 clause 1 places health supplements on the registered route, and Article 4 clause 1 excludes anything caught by Article 6 from self-declaration. The certificate must be issued before the product may circulate.
2. Decree 46/2026 came up in my search. Should I prepare my dossier to it?
No. It was issued on 26 January 2026 and suspended by Resolution 09/2026/NQ-CP, then by Resolution 15/2026/NQ-CP of 6 April 2026, which tied the suspension to the amended Law on Food Safety taking effect. Prepare against Decree 15/2018/ND-CP.
3. My product is sold as an ordinary food in my home market. Does that settle the route in Vietnam?
No. Article 3 clause 1 classifies by composition, by dosage form and by stated purpose, so something in capsule, tablet, granule, powder or liquid form, built on vitamins, minerals, probiotics or other bioactive substances and carrying a functional statement, can meet the Vietnamese definition regardless.
4. Do I need a Vietnamese company before I can declare a product?
Not necessarily one of your own. Under Article 2 a party established here files it — commonly the importer or appointed distributor. Agree in writing who holds it first.
5. If we change importer, does the existing certificate move with the product?
No. It is issued to a named organisation, so a new party responsible for placing the goods on the market registers its own declaration under Articles 6 to 8. Plan the handover of the technical file and settle beforehand whether the manufacturer’s documents may be reused.