How to Register Health Supplements in Vietnam (VFA) — 2026 Guide
For health supplements, registration is the product in Vietnam — you can't import, list, or get into a pharmacy chain without the Vietnam Food Administration's Certificate of Registered Product Declaration. And it's a bigger project than cosmetic notification: it needs GMP, ISO-17025 testing, and scientific evidence, and the rules are tightening after the 2025 counterfeit scandals. This guide walks the process under Decree 15/2018/NĐ-CP: the dossier, timelines, 5-year validity, and labeling. Figures as of 2026-10-11; not legal advice — confirm current requirements with a Vietnamese regulatory advisor.
Step-by-step
- 1
Classify your product — supplement, not ordinary food
Under Decree 15/2018/NĐ-CP, ordinary processed food uses a fast self-declaration (tự công bố), but health supplements (thực phẩm bảo vệ sức khỏe), foods for special medical purposes, and foods for children under 36 months require the stricter registration of product declaration (đăng ký bản công bố) with authority approval before sale. Get the classification right — it decides your whole pathway.
- 2
Appoint a Vietnam-based importer and confirm GMP
A foreign brand needs a Vietnam-registered importer (with IRC/ERC) as the responsible entity. Confirm your manufacturer holds a GMP certificate (or equivalent) — mandatory for health supplements since 1 July 2019. No GMP, no registration.
- 3
Test the product and gather scientific evidence
You need a food-safety test result from an ISO-17025-accredited lab, issued within 12 months, plus scientific evidence of the ingredient effects. For vitamins and minerals, the content must be at least 15% of the Recommended Nutrient Intake (RNI) and not exceed the permitted maximum under Circular 43/2014.
- 4
Assemble and legalize the dossier
The dossier includes the product declaration form, a Certificate of Free Sale or Health Certificate from the origin country, the ISO-17025 test result, scientific evidence, the GMP certificate, the importer's licenses, product samples, and the label. Foreign documents (CFS, GMP) generally need notarization, consular legalization, and Vietnamese translation.
- 5
Submit to the VFA and answer deficiency requests
Submit the registration dossier online to the Vietnam Food Administration (VFA) under the Ministry of Health. The authority reviews for completeness and compliance and may request clarifications or additional evidence — respond promptly to avoid restarting the clock.
- 6
Receive the Certificate of Product Declaration
On approval, the MoH issues a Certificate of Registered Product Declaration; only then can you import and sell. Plan realistically for several months end-to-end (document prep, legalization, testing, and review), not the headline processing window. The certificate is valid 5 years.
- 7
Label correctly and register advertising
The Vietnamese label must carry the phrase "Thực phẩm bảo vệ sức khỏe" (health supplement) and the mandatory disclaimer that it is not a medicine and does not replace medicine. Health-supplement advertising content must be registered/approved before publication — false advertising is exactly what regulators cracked down on in 2025.
The registration dossier
| Document | Notes |
|---|---|
| Registration of product declaration form | Per Decree 15/2018/NĐ-CP (Form 02) |
| Certificate of Free Sale (CFS) or Health Certificate | From the origin country; legalized |
| ISO-17025 food-safety test result | Issued within 12 months of submission |
| Scientific evidence of ingredient effects | Vitamins/minerals ≥15% RNI (Circular 43/2014) |
| GMP certificate (or equivalent) | Mandatory for health supplements since 1 Jul 2019 |
| Vietnamese importer licenses (IRC/ERC) | The responsible entity |
| Product label / samples | Vietnamese label; "Thực phẩm bảo vệ sức khỏe" + not-a-medicine disclaimer |
Government appraisal fee is around VND 1,500,000 per product for the declaration registration; a facility GMP food-safety certificate is far higher. The larger real costs are legalization, ISO-17025 testing, and regulatory consultancy. Register per SKU.
The registration and import chain
Supplements add two gates that cosmetics don't have: a GMP certificate for the factory and a lab test from an accredited laboratory. Because each gate depends on the one before it, delay at any step pushes your launch date back one-for-one.
-
Classify the product
You + adviserDecide whether it is a health supplement (registration track), ordinary food (self-declaration) or a cosmetic. Beauty-from-within products such as collagen are usually supplements.
Gate: The claims you want to make decide the classification, not the packaging.
-
Appoint the importer and confirm GMP
Importer + manufacturerA Vietnam-registered importer becomes the responsible entity; the factory must hold a GMP certificate or equivalent.
Gate: No GMP, no registration.
-
Test and document the evidence
ManufacturerAn ISO-17025 food-safety test result issued within 12 months, plus scientific evidence for the declared function (or an efficacy test report).
Gate: The test result must be issued within 12 months of submission.
-
Legalize the dossier
Brand + importerCertificate of Free Sale or Health Certificate, GMP certificate and licences, notarized, legalized and translated into Vietnamese.
Gate: Names and addresses must match across every document.
-
Submit to the VFA and answer questions
ImporterThe authority checks completeness and compliance and may request more evidence.
Gate: Slow replies restart the clock.
-
Receive the declaration certificate
VFA / Ministry of HealthThe certificate is valid for 5 years and is what marketplaces and pharmacy chains ask to see.
Gate: No certificate, no import and no listing.
-
Get the label and advertising approved
ImporterVietnamese label with the health-supplement wording and the not-a-medicine disclaimer; advertising content licensed before it runs.
Gate: Claims must match the evidence in the dossier.
-
Import, clear customs and distribute
Importer / distributorCustoms clearance is handled by the importer; stock then goes to marketplace warehouses and pharmacy distributors.
Gate: Model landed cost with real quotes before committing volume.
Process summary from Decree 15/2018 and VFA procedure; steps and documents may change as the Decree 46/2026 changes settle. We have no reliable cost-per-shipment figure — get quotes from importer and logistics providers.
How long it really takes
By comparison, a cosmetic notification takes about 1.5–3 months end-to-end, so budget roughly twice as long for a supplement. The slowest parts — testing, legalization and answering deficiency requests — are the ones you control, so start them in parallel.
Supplements vs cosmetics vs ordinary food
The compliance pathway depends entirely on classification:
- Ordinary processed food — fast self-declaration (tự công bố); you declare and can sell.
- Health supplements — registration of product declaration with VFA approval, GMP, and testing (this guide).
- Cosmetics — a DAV notification, lighter than supplement registration — see our cosmetic registration guide.
Beauty-from-within products (e.g. collagen) usually fall under health supplements, not cosmetics — classify carefully.
| Route | Process | GMP | Ad rules | Realistic time |
|---|---|---|---|---|
| Ordinary processed food | Self-declaration | Food-safety compliance | General advertising law | Fastest |
| Health supplement | Registration with VFA approval | Mandatory | Content licensed before it runs | 3–6 months |
| Cosmetic | DAV notification | Not part of the notification dossier | Pre-approval abolished Feb 2026 | About 1.5–3 months |
Cosmetic row from our cosmetic registration guide; the supplement row repeats this page's figures.
Claims, advertising and enforcement
The certificate lets you sell; it doesn't let you say anything you like. Regulators have focused on claims since the 2025 counterfeit and false-advertising scandals.
- Ads need a licence. Supplement advertising content is approved before publication, and the Ministry of Health's Decision 1644/QĐ-BYT (11 June 2026) is reported to move that licensing to provincial level. Ads must not suggest the product is a medicine and must carry the "not a medicine, not a substitute for medicines" disclaimer.
- Superlatives are fined. Decree 87/2026, effective 15 May 2026, sets fines of VND 10–20 million for unsubstantiated superiority claims such as "number one". The report we relied on also describes suspension of declarations for repeat offenders — verify whether that applies to supplements.
- Violations are published. In Q2 2025 the VFA reported a health supplement fined VND 25 million for non-compliant advertising on its website.
- Banned substances. Circular 10/2021/TT-BYT lists substances that may not be used in health supplements; check your formula against it before you test.
Dates, decisions and penalty figures are from trade-press and law-firm summaries (ChemLinked, Tuổi Trẻ, Tilleke & Gibbins, Cisema), not primary texts. Verify against the official documents before relying on them.
Frequently Asked Questions
Do health supplements need registration in Vietnam?
Yes. Unlike ordinary processed food (which uses a fast self-declaration), health supplements require the stricter 'registration of product declaration' under Decree 15/2018/NĐ-CP, with Vietnam Food Administration (VFA) approval before import or sale. E-commerce platforms and pharmacy chains request the Certificate of Registered Product Declaration and will not list products without it.
How long does supplement registration take in Vietnam?
Plan for several months end-to-end. The headline processing window is short once a complete dossier is accepted, but document preparation, CFS/GMP legalization and translation, ISO-17025 lab testing (often 1–2 months), and any deficiency responses dominate the real timeline — commonly 3–6 months total. The certificate is then valid for 5 years.
Is GMP required to sell supplements in Vietnam?
Yes — a GMP certificate (or equivalent) for the manufacturing facility has been mandatory for health supplements since 1 July 2019. Without it, the product cannot be registered. This is one reason supplement registration is a bigger project than cosmetic notification.
What changed for supplements in 2026?
Two things raise the bar. Decree 46/2026/NĐ-CP (issued 26 January 2026) set out tougher food declaration, registration and import rules, but its implementation was paused by Resolution 09/2026/NQ-CP and certain provisions again by Resolution 15/2026/NQ-CP, with Decree 15/2018 staying in force meanwhile — confirm the current status with the VFA. Separately, the 2025 counterfeit and false-advertising scandals triggered stricter enforcement and a review of Decree 15/2018 — expect more inspections and tougher scrutiny of claims and advertising. Some advisers recommend a wait-and-see stance while the rules settle.
Sources
- Decree 15/2018/NĐ-CP (product declaration for food/supplements); Circular 43/2014/TT-BYT (RNI limits); Decree 46/2026/NĐ-CP, Resolutions 66.13, 09 and 15/2026/NQ-CP (2026 food-safety changes, implementation partly suspended)
- VFA / Ministry of Health registration procedures; Artixio nutraceutical registration guidance
- NutraIngredients — 2025 counterfeit scandals & regulatory review
- Tilleke & Gibbins and Cisema (Decree 46/2026 and its suspensions, efficacy evidence); ChemLinked and Tuổi Trẻ (Q2 2025 VFA violations, Decree 87/2026, Decision 1644/QĐ-BYT)
- Related rules on our regulation tracker
A sourced reference, not legal, medical, or tax advice. Supplement regulation is being revised — confirm the current VFA requirements and your product's classification with a qualified Vietnamese regulatory advisor before filing.