Cosmetic Market Entry in Vietnam — a Foreign-Company Guide

This page is written for the foreign cosmetic company evaluating Vietnam as a new market. It answers the practical questions that come up in the first planning conversations — before an appointed local partner is on retainer, before a country-of-origin certificate is legalised, and before the online notification portal is accessed. The intent is to give the foreign team an accurate mental model of what a Vietnamese cosmetic notification is, how the ASEAN framework maps onto Vietnamese national rules, and where the real friction lies.

What Medibase does and does not do:

• Medibase is a Regulatory Technology (RegTech) reference and tools platform. It does not act as a Local Responsible Company, does not file cosmetic notifications on behalf of a foreign brand, and does not act as a legal representative in Vietnam. Anyone pitching those services as "Medibase" is not affiliated with Medibase.
• Medibase does provide free tools that accelerate the diagnostic and planning stages: the Ingredient & Substance Checker (screens INCI names and CAS numbers against ASEAN Cosmetic Directive Annex II/III and the Vietnamese MoH prohibited-substance annexes carried forward under Circular 06/2011/TT-BYT), the Expiry / Renewal Calculator, and the Regulatory Impact Simulator wizard. All tools are on /tools/.

What Vietnamese cosmetic notification is: Vietnam operates the ASEAN Cosmetic Notification (ACN) framework, meaning cosmetics do not require pre-market marketing authorisation. Instead, before first sale in Vietnam the responsible party notifies the competent authority and, on receipt, obtains a number (số tiếp nhận phiếu công bố sản phẩm mỹ phẩm) that must appear on the label and in customs documents. Notification is faster and lighter than the drug MA regime — measured in weeks rather than months — but the substantive obligations on ingredient composition, labelling, claims, adverse-event reporting and post-market surveillance are not lighter. They are the substance of the regime.

The competent authority is the Drug Administration of Vietnam (Cục Quản lý Dược — DAV) Cosmetics Division for most cases, with the provincial Department of Health (Sở Y tế) handling domestically manufactured cosmetics under Circular 06/2011/TT-BYT as amended. The legal basis is Circular 06/2011/TT-BYT (national implementation of the ASEAN Cosmetic Directive), amended by Circular 34/2025/TT-BYT (effective 18 August 2025), together with Decree 117/2020/NĐ-CP on administrative sanctions and Decree 38/2021/NĐ-CP on advertising penalties.

Who may hold the notification:

• A Vietnamese-registered legal entity — either the foreign brand's wholly owned subsidiary, or a Vietnamese distributor or partner acting as the Local Responsible Company (Doanh nghiệp chịu trách nhiệm đưa sản phẩm ra thị trường tại Việt Nam).
• The foreign manufacturer directly — only if it has a registered Vietnam representative office. A bare distribution agreement is not enough; the Vietnamese counter-party must be a substantive legal entity capable of bearing post-market obligations.
• The notification number is issued to a specific responsible party. If that party changes — for example the foreign brand switches distributors — a new notification is required. This is the single most common source of friction when a brand transitions from an initial launch distributor to a growth-stage partner.

How to read this page: The comparison table below summarises the timeline, cost, and complexity of the four common cosmetic-entry pathways. "Recent updates" walks through the six substantive changes under Circular 34/2025 and what they mean for a first-time entrant. "Key documents" is the authoritative legal stack. "Resources & links" gives the operational portals a local partner will actually log into. The FAQ closes with the seven questions that come up most frequently in initial planning conversations.

Primary legal instruments:

• Circular 06/2011/TT-BYT — Vietnamese national implementation of the ASEAN Cosmetic Directive; the operative rulebook for cosmetic notification, ingredient annexes, and labelling. Sets the notification workflow, the annex structure (Annex II prohibited substances, Annex III restricted substances, Annex IV colorants, Annex V preservatives, Annex VI UV filters), and the responsibilities of the Local Responsible Company.
• Circular 34/2025/TT-BYT — issued 4 July 2025, effective 18 August 2025; amends and supplements Circular 06/2011/TT-BYT. Introduces revised annex formats, updated Product Information File (PIF) requirements, and clarified enforcement procedures.
• ASEAN Cosmetic Directive (ACD) — the regional harmonised framework that Circular 06/2011 transposes into Vietnamese law; the substantive definitions of "cosmetic", the notification form, and the ingredient annexes come from the ACD.
• Decree 117/2020/NĐ-CP — administrative sanctions in the health sector; sets the fine schedule for cosmetic-notification violations, including undeclared ingredients, false claims, and failure to notify before market launch.
• Decree 38/2021/NĐ-CP — advertising sanctions; applies to cosmetic advertising claims that exceed what the notification supports (see /cosmetic/product-claims/).
• Decree 43/2017/NĐ-CP as consolidated by Decree 111/2021/NĐ-CP (Nghị định hợp nhất) — labelling requirements applicable to cosmetics sold in Vietnam; Vietnamese-language mandatory label content, ingredient list format, importer information.

Related Medibase pages:

• Cosmetic notification workflow — /cosmetic/product-notification/
• Cosmetic labelling — /cosmetic/labelling/
• Cosmetic ingredient safety — /cosmetic/ingredient-safety/
• Cosmetic product claims — /cosmetic/product-claims/
• ASEAN Cosmetic Notification template — /templates/cosmetic-notification/
• Cosmetic Product Information File template — /templates/cosmetic-pif/

This section walks through the four common market-entry pathways side by side, then covers what changed under Circular 34/2025 (in force 18 August 2025), then closes with the six frequent rejection reasons a first-time entrant should proof against before submission.

What changed under Circular 34/2025/TT-BYT (in force 18 August 2025):

• Product Information File (PIF) format revised: the ASEAN CPNP-aligned PIF sections were re-numbered and expanded, with new sub-sections on nano-material declaration, allergen listing per ISO 22715, and preservative-efficacy test method identification. Existing PIFs remain valid but must be brought to the new format at the next material update or five-year refresh.
• Annex III restricted-substance list synchronised with the ACD 2025 update — several substances tightened, one delisted. Registrants using formulations at the previous maximum concentration should re-check the Ingredient & Substance Checker at /tools/?tab=ingredient.
• Adverse-event reporting timelines aligned with the ACD Post-Marketing Alert System (PMAS): serious adverse events (SAE) reported within 15 calendar days of first knowledge; non-serious events on the annual PSUR.
• Advertising claims that go beyond the notified product benefits now trigger a mandatory advance-approval requirement — previously the enforcement was ex-post via Decree 38/2021 sanctions. Practical effect: the notification and the advertising script must align before launch.
• Online-notification portal enhancements: the DAV cosmetic portal now accepts electronic signatures under Law 20/2023/QH15 (in force 1 July 2024), reducing the wet-signature burden.
• Clarified role of the provincial Sở Y tế for domestic manufacturers — imported cosmetics remain routed through DAV headquarters.

Six frequent rejection reasons — proof against these before submission:

• Ingredient not on any approved ASEAN annex and not in the Annex II prohibited list: this triggers a "confirm intended use and function" query that adds two to three weeks. Pre-screen the full INCI list against Annex II/III/IV/V/VI via the Ingredient & Substance Checker.
• Vietnamese-language label content missing or non-compliant: the supplementary label must carry the required Vietnamese-language content per Decree 43/2017 consolidated. Products imported for retail must have this in place at customs, not applied post-import.
• Local Responsible Company address does not match the business licence: the address on the notification form must exactly match the business registration certificate. A subsequent address change requires an updated notification.
• Claims not supported by the PIF: any claim (whitening, anti-ageing, sensitive-skin, dermatologist-tested) must have supporting evidence in the PIF Section 8 (safety assessment) or Section 9 (efficacy).
• CFS from a non-ACD country not legalised: Vietnam accepts Certificates of Free Sale from any country, but non-ASEAN CFSs must be consularised (or Apostilled, from 11 September 2026 for Hague signatories) before submission.
• Missing GMP certificate for the manufacturing site: cosmetics must be manufactured under ASEAN Cosmetic GMP or equivalent (ISO 22716). The GMP certificate must be current at the time of notification and referenced in the PIF Section 3 (manufacturing).