August 2025

Thailand: FDA Announces Updated Prescribed Forms for Medical Device License and Notification Renewals

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 forms align more closely with […]

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Thailand: Exemption of Specific Documents for Medical Device License or Notification Renewals

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. The decision comes under Section

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Malaysia: Implementation of the Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase I)

On July 30, 2025, the Medical Device Authority (MDA) released an official announcement regarding the Implementation of the Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase I). The programme is a result of a Memorandum of Understanding (MoU) signed between the MDA (Malaysia) and the National Medical Products Administration (NMPA) (China), aligning with the principles

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Indonesia: Deactivation of e-Catalogue Version 5 for Construction and Healthcare Showcases – Circular Letter No. 2/202

On July 22, 2025, the Head of the National Public Procurement Agency (Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah – LKPP) issued Circular Letter No. 2 of 2025 concerning the Deactivation of the e-Catalogue Version 5 for Construction and Health Showcases. To view the official document (Bahasa Indonesia only), refer to:Circular Letter No. 2 of 2025 –

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Thailand: Thai FDA Announces System for Medical Device License and Notification Renewal

On July 23, 2025, the Thai Food and Drug Administration (Thai FDA) announced a new system for the renewal of medical device licenses and notification certificates, to be submitted annually through the SKYNET online platform. To view the official announcement and infographic, refer to:กองควบคุมเครื่องมือแพทย์ (Medical Device Control Division) Key Highlights Annual Renewal Period Medical device

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