A medical device is designated under the Thai FDA as any device that promises or claims to have a medical, dental or therapeutic use. You will also be required to obtain a medical device license if you are looking to become a medical device importer, even if the device is considered software as a medical device or purely for aesthetic purposes. FDA Thailand splits all medical devices into four categories, all of which have different fees and timelines associated with obtaining a medical device license. If you are interested in medical device registration in Thailand it is recommended to seek consultation from a Thailand medical device law firm. As the process can be quite complex, especially if you do not speak the Thai language, having medical device registration lawyers as a resource is certainly to your benefit.
All medical device registration must go through the Thailand Food and Drug Administration or Thai FDA. The laws in Thailand regarding medical device registration also intersect with the ASEAN Medical Devices Directive. As stipulated within FDA Thailand law, medical devices are segmented into four separate classes, each of which carries its own associated fees and length of time it will take the administration to award you a medical device license. This process can be quite complex and it is advised to bring on the services of Thailand medical device law firm. Paperwork and documentation are paramount when it comes to Thailand medical device registration, so hiring a local law firm to aid in Thailand is the best way to ensure everything is in order.
If you are planning to open a business that encompasses importing medical devices into Thailand you will be required to obtain a medical device license in accordance with the Thai FDA. FDA regulations for medical devices are split into four different categories or classes. In order to receive your medical device license, you will have to meet the requirements stipulated under the class you fall under. Medical device registration in Thailand can be a bit confusing, especially for those who are not fluent in the Thai language. Choosing a Thailand medical device law firm to guide you through the process is recommended.
The fees associated with acquiring a medical device license in the Kingdom of Thailand will depend on what classification the device is designated under the Thai FDA. There are four classifications in total, all of which have different fees and timelines associated with your medical device registration. Thailand welcomes all forms of business with open arms, as long as you follow the law. Importing a device without following FDA regulations for medical devices can result in fines and even imprisonment and deportation. Hiring a Thailand medical device law firm is widely recommended to ensure that you are in accordance with Thai FDA law.