• Peerapan Tungsuwan and Panyavith (Taro) Preechabhan
• 2024-10-19
• Trade Show News
• (0)

Thailand: New FDA regulations on medical references

in short The U.S. Food and Drug Administration (FDA) now allows access to medical device application materials and the transfer of product registration licenses. To minimize redundancy in expert review of registration dossiers and assist manufacturers and importers holding Class II, III, and IV medical device product registration licenses, FDA now allows business operators to refer to registered products Registration dossier in which a business operator simply seeks to own a new brand name for its product in order to obtain a new product license for the new brand name of a previously registered product. Additionally, the new regulations allow for the transfer of a medical device product license to another operator if the location of the manufacturing facility remains unchanged when the importer or manufacturer entity changes. To be eligible for citation or transfer of an application dossier or product registration license, the main requirement is that the referenced application dossier must have a complete dossier that complies with…