In EU, Dermal Filler are considered Class IIb Medical Device (Medium Risk). However in Thailand, until last October, hyaluronic acid filler was classified as a pharmaceutical product. Thus, Thai FDA Certification process was more stringent and, depending on category, requirements more burdensome, especially since Companies would not necessarily be able to provide the quality, clinical and no-clinical parts required for new drugs.
On 24 October 2018, the Thai FDA re-classified injectable hyaluronic acid (filler) as Medical Device according to the ASEAN Medical Device Directive (AMDD). Thus current importers and distributors of this product will need to obtain a license to operate for the importation of medical devices into Thailand.
This new regulatory scenario opens up exceptional opportunities for the Italian and European producers of Dermal Fillers, considering that Thailand is the hub of this segment throughout Southeast Asia.
The Thailand facial aesthetic market is expected to grow at a CAGR of 9.82% until 2020, led by non-invasive treatments such as Botox and Hyaluronic Acid. In Thailand there are more than 340 beauty clinics and many of the 400 private hospitals performing aesthetic treatments based on hyaluronic acid injecting.
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