On October 4, 2024, Thai FDA released an announcement in their website about processes involving approved license. The Thai FDA defines the following: Refer: For the process that requires referring the approved dossier of medical devices to new dossiers with changes new name for the medical device (Change of Brand
On October 3, 2024, the Thai FDA announced updates to the consent form used for the Reliance Program. In the updated version, it is no longer necessary to include the reference number for the application submission to the Thai Food and Drug Administration. Applicants can now prepare the consent form
Last September 30, 2024, the Thai FDA Facebook page shared an infographic on how to classify wound dressing products according to the Thai Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019). Related stakeholders shall consider the criteria when determining whether or
On October 2, 2024, the Thai FDA published an infographic on its official website about the Renewal, Termination, and Non-Renewal of five (5) Thai FDA Licenses applicable for local importers and manufacturers. The steps to be taken are as follows: Download the forms from the Medical Device Control Division’s website.
On September 12, 2024, the Ministry of Health (MoH) of Vietnam issued Official Letter No. 365/HTTB-ĐKKD concerning the handling of medical device import applications submitted before January 1, 2022, which have not been approved yet. The key points are as follows: 1. Review of Pending Applications: applicants must review their
The Health Sciences Authority (HSA) Singapore conducted a workshop to elaborate on the correct procedures, processes, roles and responsibilities of a registrant and a dealer during submission of documents with the Medics and Oscar systems. The highlighted information is as below: Listing of existing tools and guidelines for specific group
Subscribe to our Newsletter
Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!
