THAI FDA REGISTRATION
REGULATORY SERVICE THAILAND
Thai FDA Registration – Regulatory Service
FDA REGISTRATION IS MANDATORY FOR ALL COSMETICS AND MEDICAL DEVICES. KHA BANGKOK Regulatory Services Thailand WILL DO IT FOR YOU.
The Thai FDA is the government department responsible for issuing licenses to importers and producers of medicines, food, food supplements, medical devices, cosmetics,and all other potentially harmful substances. Anyone intending to import such products in Thailand needs to obtain a registration from the FDA. The Thai FDA also has authority to control product advertising, ensuring that the claims made by producers are backed by proper evidence and studies.
The main aim of the FDA is the protection of consumer health and this is done for every aspect of a product’s life: when and where the product is made, the production conditions and whether the final product complies with relevant Thai laws and regulations. The FDA also monitors product standards by carrying out periodic checks.
MEDICAL DEVICE ACT
Regulatory Services Thailand By Kha Bangkok, the solution for your Business
The Thailand FDA has a clear procedure to follow depending on the type of product that you will import. In general though, importers need to provide fairly comprehensive details about the company that will import the product, plans and photos of the production facility and evidence to show that they meet all Thai law requirements in respect of manufacturing, including, for example, lighting and ventilation, proper areas for preparation, the type of equipment that they will use.
As always, it can be difficult to navigate through fairly substantial documentation requirements and, as providing incomplete documentation can cause substantial delays, it is very worthwhile consulting an expert in this field, who can assist you in completing the documentation and making sure you have given the FDA an adequate amount of information.
The ThaiFDA has issued the amended Medical Device Act (Issue 2) B.E. 2562 (2019), which will come into effect in October 2019. This supersedes the Medical Device Act BE 2008
WE embed here both laws for your knowledge.
Kha Bangkok Regulatory Services Thailand offers the service of Regulatory, Licence Holder and Distributor for your products subject to FDA registration. Contact us for more information.