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Factors to Consider When Hiring a Medical Device License Lawyer
If you're looking to start an enterprise for medical devices in Thailand, you should look for a medical device license lawyer. The lawyer will assist you with all the paperwork and documentation needed to obtain your Thai medical device license. The lawyer will also provide legal advice on the various aspects of getting the license. Here are a few important things to keep in mind when hiring an attorney for medical device licensing in Thailand.

Thai Food and Drug Administration (Thai FDA).

You might be wondering where to begin in the search for an Thai medical device license. The process can be complex and requires a lawyer with extensive experience in obtaining medical device licenses. devices. There are lawyers who specialize in this type of registration and will be able to help you get the medical device license you need to advertise your device.

It is crucial to understand the requirements of the Thai FDA. This agency regulates medicines, devices, and food. There are strict guidelines for getting an approval. The FDA is a busy workload, so the process can take some time. If you employ an attorney for medical device licensing with experience working with the FDA to speed up the process and avoid unnecessary delays.

Ethics committees, which review clinical trial protocols

An IRB, or Institutional Review Board, is a committee that reviews the protocol of an investigational trial. Its job is to ensure that the study does not violate the rights of animals or people, and that its actions are in line with ethical principles and applicable regulations. Initially, Thailand medical device license lawyer were independent organizations that examined academic and medical institutions and attempted to minimize ethical issues. Now, some IRBs review protocols for commercial firms. These IRBs follow US federal regulations and must safeguard the rights of all trial subjects, with particular attention to those with disabilities as well as those at risk of harm.

The ethics committee also examines the trial protocol to determine if it is acceptable. It also examines the credentials of the health professionals conducting the trial. The committee may make recommendations to improve the study's integrity and can also recommend changes.

Appeal Period

The decision of the licensing authority can be appealed. However it is crucial to note that this process could take a certain amount of time. The Minister of Public Health can extend the to consider an appeal if required. A hearing can take up to 30 days. If the appeal is rejected the appellant is able to appeal to a higher authority.

The process of licensing usually comprises three steps. The first step is obtaining an approval from the FDA. This license costs between 10,000 to 100,000 baht. The entire process can take about 30 days.
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