On January 30, 2025, the Thai Food and Drug Administration (Thai FDA) issued new Change Notification Guidelines for Notified and Licensed In Vitro Diagnostic (IVD) Medical Devices. These guidelines outline updated regulatory requirements and take effect from January 15, 2025. The full announcement is available on the Thai FDA Official
The Medical Device Control Division has introduced an updated Change Notification System for medical devices in Thailand, effective January 15, 2025. The newly issued guideline regulates the increase or decrease of medical device items within the same medical device group without affecting their category classification. This guideline has been published
On January 24, 2025, the Food and Drug Administration (FDA) of the Philippines announced the temporary suspension of pre-assessment fees for specific applications, as outlined in FDA Advisory No. 2025-0076. This decision aims to address challenges in implementing Administrative Order (AO) No. 2024-0016, which establishes a new schedule of fees
The National Public Procurement Agency (LKPP: Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah) under Indonesia’s Ministry of Health has extended the product registration deadline for the e-Catalogue procurement process until March 20, 2025. The e-Catalogue serves as an official government procurement platform for medical device products. Key Update Stakeholders can continue to
On January 31, 2025, the Medical Device Authority (MDA) of Malaysia released the Second Edition Guidance Document (MDA/GD/0065) on the placement of HIV Self-Test Kits (HIVST) in the Malaysian market. This updated guidance document introduces several key revisions affecting regulatory requirements, performance evaluation, conformity assessment, registration, labeling, and post-market surveillance.
On January 22, 2025, the Medical Device Control Division (MDCD) of Thailand released an infographic outlining the Priority Track for medical device registration. This initiative aims to expedite the approval process for medical devices that contribute to the prevention and management of chronic diseases, including diabetes, hypertension, hyperlipidemia, cardiovascular diseases,
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