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
On September 9, 2024, TFDA released an amendment of Ministry of Public Health Notification, RE: Medical Devices that Must Display Expiration Dates, Warnings, Contraindications, or Precautions on Labels or Instruction For Use B.E. 2563 (2020), dated on April 27, 2020. By virtue of the provisions in Section 5 paragraph one,
On September 9, 2024, TFDA released an amendment of the “Ministry of Public Health Notification, RE: Medical Devices to be Sold Only to Health Care Unit or Medical Practitioner and Public Health Professionals B.E. 2563 (2020) dated on April 27, 2020”. By virtue of the provisions under Section 5 paragraph
On September 9, 2024, TFDA released an amendment of the “Ministry of Public Health Notification, RE: Standards of Medical Devices that Manufacturers or Importers Must Comply With, B.E. 2563 (2020), dated on April 27, 2020”. By virtue of the provisions in Section 5, paragraph one, and Section 6 (4) of
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