On August 18, 2025, the Medical Device Authority of Malaysia (MDA) has updated the infographic (only editorial changes) related to REQUIREMENTS ON QUALITY MANAGEMENT SYSTEM (QMS) AND TRACEABILITY FORM applies to new medical device applications and re-registration medical device applications submitted from 1 January 2024. This infographic refers to the
On September 5, 2025, the Department of Health (DOH) issued Department Circular No. 2025-0328, officially extending the temporary suspension of Administrative Order (AO) No. 2024-0016 for an additional sixty (60) working days. AO No. 2024-0016 introduces a new schedule of fees and charges for services provided by the Food and
On August 20, 2025, the Thai Food and Drug Administration (Thai FDA) issued Announcement (Issue No. 13) B.E. 2568 (2025), updating the list of experts, expert organizations, government agencies, and private organizations—both domestic and foreign—authorized to perform duties in evaluating academic documents for medical devices. This announcement is made under
On August 20, 2025, the Ministry of Health (MOH) issued Notification Letter No. BJ.02.03/A.VI/5997/2025 concerning the follow-up transition of medical devices and pharmaceuticals in the e-Catalogue system. This follows the Circular Letter of the Head of the National Public Procurement Agency (LKPP: Lembaga Kebijakan Pengadaan Barang/Jasa) No. 2 of 2025
On July 22, 2025, the Thai Food and Drug Administration (Thai FDA) introduced updated prescribed forms for the renewal of medical device notifications and licenses, replacing the previous versions outlined in the 2021 announcements. This update is issued under Section 12 of the relevant Ministerial Regulations and ensures that the
In an effort to ease the renewal process for medical device licenses and notifications, the Thai FDA has introduced exemptions for certain documents and information, which took effect on the 22nd of July 2025. This change applies to licensees or notifiers who face difficulties in renewing their licenses or notifications.
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