Meso and Filler – Cosmetics or Medical Devices in 2026? Critical Update

In recent months, many companies in Vietnam have faced unexpected recalls of their cosmetic dossiers for mesotherapy (meso) products. This sudden shift has left importers, distributors, and doctors wondering: are meso and filler actually cosmetics, or should they be classified under the Vietnam medical device classification system (A–D)? The answer to this question determines whether your products can continue to be sold legally in 2026, or if they require an entirely new registration process. In this article, Green NRJ explores the regulatory confusion, the risks of misclassification, and the path to compliance.

Why Meso & Filler Are Not Cosmetics Under ASEAN Rules

Under ASEAN cosmetic regulations, cosmetics are strictly defined as products applied to the surface of the skin, hair, or nails, without penetrating into deeper layers. In contrast, meso and filler products do not meet this definition, as they are administered below the skin barrier, which immediately excludes them from the scope of cosmetics. These products are typically formulated with active substances designed to act directly within the dermis or subcutaneous tissue, rather than remaining on the surface. Furthermore, their use is inherently invasive, often involving microneedling or injection techniques, which go far beyond topical application. For these reasons, meso and filler products cannot be classified as cosmetics under ASEAN regulations.

Correct Classification: Filler Cosmetic or Medical Device?

When considering their method of administration and intended use, meso and filler products are classified as medical devices in Vietnam rather than cosmetics. Dermal fillers, in particular, are categorized as Class D medical devices due to their high risk level and invasive mode of application. Similarly, meso products are also treated as medical devices when they are intended for injection or delivery beneath the skin surface. As a result, these products must follow a regulatory pathway distinct from cosmetic notification, with more stringent requirements applicable to medical device registration.

Class D Medical Device Registration in Vietnam

Before any import, Class D medical devices such as dermal fillers must first obtain a valid Marketing Authorization (MA) issued by the Ministry of Health (MOH) via the DMEC portal. This MA process is stricter than cosmetic notification, as it requires detailed technical documentation, clinical evidence of safety, and quality certifications. Only after securing the MA can companies legally import and distribute fillers in Vietnam, ensuring both compliance and patient safety.

Risks of Misclassifying Meso in 2026

In 2026, businesses that continue to classify meso or filler products as cosmetics face significant regulatory and operational risks. In practice, authorities have already withdrawn previously approved dossiers, leading to product recalls and market disruption. Incorrect classification can also result in import delays, with shipments being held or blocked at customs due to non-compliance. In addition, companies may be subject to regulatory penalties, including fines or even suspension of business licenses. Beyond legal and financial consequences, reputational damage is another critical concern, as distributors and clinics may lose trust when products are unexpectedly recalled.

Correct classification is therefore not optional but essential for ensuring business continuity. In many cases, compliance issues arise during customs clearance, particularly when importing Class C and Class D medical devices into Vietnam, where regulatory scrutiny is significantly stricter.

How Green NRJ Helps With Medical Device Registration

Green NRJ supports companies in effectively navigating regulatory changes related to meso and filler products through tailored, end-to-end solutions. This includes reviewing existing cosmetic notifications to identify products that require reclassification, as well as providing expert guidance on whether a product qualifies as a cosmetic or must be registered as a medical device. In cases where medical device registration is required, Green NRJ assists in the preparation and submission of Class D medical device dossiers in Vietnam, ensuring full compliance with applicable regulations.

In addition, the company offers strategic compliance solutions aimed at minimizing regulatory risks and safeguarding business operations. By partnering with Green NRJ, businesses benefit from a reliable and experienced advisor who ensures that meso and filler products are properly classified, legally registered, and fully prepared for market entry.

Final Thoughts

In conclusion, the question of whether filler is a cosmetic or a medical device has a clear answer in the Vietnamese regulatory context: both meso and filler products must be classified and registered as medical devices rather than cosmetics. Companies that fail to align with this requirement may face significant consequences, including product recalls, import delays, and increased compliance risks that can disrupt business operations.

Businesses are therefore strongly encouraged to take proactive steps to ensure proper classification and registration. By engaging with Green NRJ, companies can efficiently reclassify and register their meso and filler products, maintain full regulatory compliance, avoid unnecessary disruptions, and continue to grow with confidence in the Vietnamese market.