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,
On January 22, 2025, the Medical Device Authority (MDA) of Malaysia released a draft guidance document for the second edition of Importation of Medical Device for Personal Use (MDA/GD/0066). This document outlines the procedures for individuals seeking to import unregistered medical devices into Malaysia for personal use. Applicants may request
The Thai Food and Drug Administration (Thai FDA) has amended its announcement regarding the importation of medical devices in quantities necessary for personal use, under Section 27(5) of the Medical Device Act B.E. 2551 (2008). The new draft, B.E. 2567 (2024), specifies conditions under which certain medical devices are exempt
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