Cosmetic product registration solutions in Vietnam – Legal & Sustainable
Cosmetic product registration solutions in Vietnam – Legal & Sustainable
Vietnam is currently one of the fastest-growing cosmetics markets in Asia, driven by young population, improving living standards, and rapidly increasing demand for beauty and personal care. In this context, many international cosmetic brands are seeking to expand their operations and introduce their products into this highly potential market.
However, before cosmetic products can be circulated in Vietnam, the entity responsible for placing the product on the market must carry out the cosmetic product declaration procedure and be granted a receipt number for the Cosmetic Product Notification Form in accordance with the regulations of the Drug Administration of Vietnam – Ministry of Health. This is a mandatory legal requirement for cosmetic products to be legally imported and distributed. Through this process, the regulatory authority can control important information related to the product such as ingredients, intended use, and the entity responsible for placing the product on the market. Proper implementation of the declaration procedure not only ensures compliance with the law but also helps enterprises limit legal risks, maintain stable business operations, and enhance brand reputation in the market.
Challenges commonly faced by enterprises?
First, no legal entity in Vietnam. For foreign cosmetic manufacturers, one of the common obstacles is the absence of a legal entity in Vietnam to stand in the name of the cosmetic product declaration. In this case, enterprises often face difficulties in choosing between:
- Establishing a legal entity in Vietnam, which involves relatively significant costs and operational management procedures; or
- Depending on a domestic distributor to stand in the name of the cosmetic product declaration, which may reduce the level of control over the product and business activities in the Vietnamese market.
Choosing the appropriate option needs to be carefully considered in order to ensure control over the product and the long-term business strategy in the Vietnamese market.
Second, classification and determination of the correct nature of the product. Some products on the market have “hybrid” functions between cosmetics, pharmaceuticals, and medical devices (for example: products for acne treatment, melasma treatment, hair loss prevention, or dermal fillers). This makes it difficult for enterprises to determine the correct regulatory scope and the appropriate form of registration. If the classification is incorrect from the beginning, the dossier may be rejected or must be adjusted, thereby prolonging the time required to bring the product to market.
Third, incomplete or improperly formatted dossier preparation. Although the cosmetic declaration dossier is simpler than that for pharmaceuticals, it still requires certain mandatory documents such as a Power of Attorney (POA), Certificate of Free Sale (CFS), ingredients in accordance with INCI standards, and maintenance of the Product Information File (PIF) as required... Missing documents, incorrect information, or failure to carry out consular legalization in accordance with regulations often result in requests for amendment or supplementation of the dossier.
Fourth, product ingredients not complying with ASEAN regulations. Some products contain ingredients that are prohibited, subject to concentration restrictions, or not permitted for use in cosmetics under the ASEAN Cosmetic Agreement. In addition, regulatory authorities are currently strengthening control over preservatives in cosmetic products. In practice, many raw materials may already contain preservatives (for example solvents, thickening agents, or surfactants) but these are not fully disclosed in the raw material documentation (CoA, MSDS, or specification).
This may lead manufacturers to unintentionally fail to fully declare preservative ingredients in the cosmetic declaration dossier. When the regulatory authority conducts inspection or post-market surveillance and discovers this inconsistency, the product may be required to adjust the dossier or even be recalled from the market.
Fifth, inconsistency of information between the dossier and product labeling. Information such as product name, intended use, ingredients, manufacturer, and country of origin,… if not consistent between the declaration form, product label, and technical documents, may lead to requests for clarification from regulatory authorities or create risks during market inspections.
Finally, even after being issued a subsequent number for the cosmetic product declaration form, the product is still subject to supervision by regulatory authorities through post-market surveillance activities. If discrepancies in information or violations related to labeling, advertising, or ingredients,… are detected, enterprises may face product recall or administrative penalties. In some cases, providing information related to the PIF dossier to distribution companies may also pose risks regarding the confidentiality of the product formula and manufacturing process.
MedNovum – Strategic legal partner in the Vietnamese market
Cosmetic product registration in Vietnam is generally not overly complicated. However, enterprises still need to clearly understand the legal regulations, prepare accurate dossiers, and ensure consistency of information across all related documents. Thorough preparation from the beginning will help shorten the product declaration timeline, limit legal risks, and bring products to market more quickly.
Proud to be one of the pioneering consulting firms in Vietnam providing Marketing Authorization Holder (MAH) services for the Vietnamese market, MedNovum has cooperated with many international partners and manufacturers. We possess practical experience and a deep understanding of the legal system and regulatory framework governing cosmetics, dietary supplements, pharmaceuticals, and medical devices.
MedNovum’s professional team includes pharmacists, lawyers, engineers, and consultants working under a multidisciplinary collaboration model. Thereby, we are able to support clients in preparing dossiers in a systematic manner, minimizing legal risks, optimizing dossier processing time, and building a solid compliance foundation when entering and developing business activities in the Vietnamese market.
Cosmetic declaration services provided by MedNovum
- Consulting on product classification in accordance with current legal regulations
- Preparing and completing the cosmetic product declaration dossier
- Reviewing technical documents to ensure compliance and validity under regulatory requirements
- Representing enterprises in submitting dossiers and working with regulatory authorities
- Supporting procedures for amendments and supplements after the product has obtained the notification number, maintaining the PIF dossier, and providing support in cases of inspections by competent authorities
With experience in the regulatory, pharmaceutical, and cosmetics sectors, MedNovum provides comprehensive MAH solutions to help international enterprises access the Vietnamese market quickly, safely, and effectively.
Please provide basic product information so that the MedNovum team can conduct a preliminary feasibility assessment and propose an appropriate registration roadmap in accordance with Vietnamese law.
We commit to providing timely responses with clear, transparent analysis and practical guidance to effectively support the Client’s plan to enter and develop in the Vietnamese market.