Thailand drafts stricter rules for cosmetic skin injections
Thailand’s FDA has opened a public hearing on draft rules to tighten controls on skin-defect injection products and strengthen consumer safety.
- Thailand is drafting new regulations to cover all types of cosmetic skin injectables, as current rules only apply to hyaluronic acid, leaving a legal and safety gap.
- The proposed rules will require all manufacturers, importers, and sellers of these products to obtain a license before operating.
- Sales of injectable fillers will be restricted to medical facilities and licensed medical or dental practitioners to ensure consumer safety.
- The draft also mandates that products meet medical device standards and introduces the possibility of criminal penalties for selling illegal or substandard items.
The Food and Drug Administration (FDA), Ministry of Public Health, has opened a public hearing on the draft Notification of the Ministry of Public Health on injectable products for correcting skin defects, from April 17 to May 16, 2026, before it is formally enforced.
The move aims to raise safety standards for consumers as demand for skin filler injection services continues to increase.
Background to the problem
At present, the market for injectable products used to correct skin defects is developing rapidly, with a wide range of active substances now being used, including both natural and synthetic materials, beyond the well-known hyaluronic acid.
As a result, many products do not fall under the scope of the previous Ministry of Public Health notification issued in 2019, which covered only hyaluronic acid products.
This legal gap has led to unequal regulation of products in the same category, even though they share the same purpose, method of use and level of risk.
Some products have therefore escaped safety standards and sales controls.
Key points of the draft notification
The draft notification defines “injectable products for correcting skin defects” as covering products containing any type of active substance, provided that they are intended to be injected to add volume beneath the skin, with the following key measures:
Licensing system: All manufacturers, importers and sellers must obtain authorisation before operating.
Sales restrictions: Products may be sold only to medical facilities, medical and dental practitioners, or licensed sellers of medical devices.
Product standards: Products must meet medical device standards and manufacturing quality system requirements.
Labelling and accompanying documents: These must display information in accordance with the criteria set out in the 2025 notification.
Transitional provisions: Operators already holding licences may continue to use their existing licences and labels for the period specified.
Penalties and enforcement
The Ministry of Public Health has stressed the need for criminal penalties to deter the illicit manufacture, import or sale of substandard products, which could pose direct risks to consumers.
Groups affected
The draft notification affects manufacturers, importers and sellers of these products, medical and public health personnel, state officials responsible for enforcement, as well as members of the public who use such services.
The Ministry of Public Health is inviting comments from all relevant sectors before the draft is revised and formally promulgated.
