Thailand Medical Device License and FDA Medical Device Registration Lawyers Bangkok
If you are planning to import and/or bring a medical device with you into the Kingdom, you will be required to obtain a medical device license. In Thailand, medical device registration is regulated under two acts. Thailand’s Medical Device Act/Ordinance B.E. 2562 (2019) and its predecessor the Medical Device Act B.E. 2551 (2008). These acts work in conjunction with ASEAN Medical Devices Directive. Thai FDA medical device registration is required for all devices that claim to provide dental, therapeutic or medical aid. Thai FDA regulations for medical devices also cover software as a medical device as well as devices used for aesthetic reasons. Vize Counselor is your dedicated medical device registration lawyer, we have the experience with the Thai FDA to get your medical device license.
Medical Device Registration is Conducted by the Thai Food and Drug Administration
All medical device registration is regulated by the Thai Food and Drug Administration (FDA). Thailand has become an attractive country for medical tourism and as a result, has implemented further regulations in order to keep up with safety standards. Vize Counselor is the leading Thailand medical device law firm and you can trust us to make sure everything is in legal order for your medical device. We have a wealth of experience when it comes to FDA medical device regulation, so if you are planning on importing medical devices our team is ready to help you. Contacting us is easy, just contact us through the website about your Thailand medical device licence today!
The Thailand Medical Device Classification System
In Thailand, medical device regulatory compliance is compulsory. Adhering to the Medical Device Act of B.E. 2551 or 2008 and all other associated acts is a legal necessity. As designated in these acts, importing medical devices requires that you first obtain a medical device import license. Depending on the type of device you are looking to import, you will fall under a total of four classes.
CLASS 1 MEDICAL DEVICES
Government Fees: $105
Review Timeline: 200 days
CLASS 2 and 3 MEDICAL DEVICES
Government Fees: $1,080
Review Timeline: 250 days
CLASS 4 MEDICAL DEVICES
Government Fees: $1,775
Review Timeline: 300 days
The pricing schedule and amount of time associated with importing medical devices into Thailand will depend on the classification of said device. A medical device importer will be required to supply sufficient documentation of the device or devices that will be imported. Based on this information the Thai FDA will designate which class the medical device importer and its various products will fall under within Thai law. Medical device registration in Thailand can be easy with Vize Counselor. You can rely on our knowledge of the medical device manufacturing industry and how it applies to your medical device license. Our team of medical device registration lawyers will see to it that all of your needs are met when it comes to FDA regulations for medical devices. We specialize in medical device registration, all it takes is a simple message and we are there to help you obtain your medical device license.
Thailand FDA Medical Device Registration Requirements and Costs
The costs associated with medical device registration will vary depending on the device you wish to import and what its classification is to the Thai FDA. A Thailand medical device license is certainly obtainable and you can even open a business as a medical device importer if you so choose. Vize Counselor is here to help you with importing medical devices to Thailand. Let us do the hard work for you when it comes to obtaining your medical device license. We have a deep understanding of FDA regulations for medical devices and can send you on the right path to becoming a medical device importer here in the Kingdom of Thailand. Don’t hesitate, let’s start a consultation today for your Thailand medical device registration!
Need Help? Contact The Vize Counselor Medical Device Registration Lawyers Today!
If you are looking to open a business in the Thailand medical device market, you have found the right place to start. Vize Counselor is a highly respected Thailand medical device law firm and our highly experienced and friendly team is here to help you achieve your dreams. One of the most important parts of obtaining your medical device license is having all of your paperwork and documentation in order. Let one of Vize Counselor’s knowledgeable medical device registration lawyers help you complete the process of your medical device registration to make sure that everything is done right the first time.
Thailand FDA Medical Device Licence and Registration FAQs
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.