The Philippines Food and Drug Administration (FDA) issued an Advisory No. 2024-0498 dated 06 March 2024, entitled “Delisting of COVID-19 Medicines and Devices from the List of VAT-Exempt Health Products”, informing the stakeholders and all concerned clients that the products used for COVID-19 shall no longer be VAT-Exempted, effective 01 January 2024. This action is […]
The Health Sciences Authority (HSA) of Singapore made several key updates to align with current International Medical Device Regulators Forum (IMDRF) regulatory recommendations regarding software/programmed or programmable medical devices. Product owners that are involved in Software as a Medical Device (SaMD) either being standalone or embedded within the Medical Device are highly suggested to be
As of December 2023, the Policy Institute for Procurement Goods/Services (Lembaga Kebijakan Pengadaan Barang dan Jasa Pemerintah (LKPP)) under Ministry of Health (MOH) Indonesia has announced the schedule of Product Listing in e-Catalogue system for Health Facility in Indonesia is open until 31 March 2024 or until further notice. For stakeholders who plan to list
The Medical Device Authority (MDA) has released the Guidance Document, MDA/GD/0005, Second Edition, entitled “General Medical Device – Grouping” to assist the industry and healthcare professionals in achieving compliance with the Medical Device Act (Act 737) and its associated regulations. The guidance document has been updated to offer direction on determining the appropriate grouping for
On March 7th, 2024, the Medical Device Authority (MDA) of Malaysia, issued Medical Device (Exemptions) Order 2024 where the Medical Device (Exemption) Order 2016 [P.U. (A) 103/2016] is revoked. The legislation covers the following: Exemption from Registration of Medical DevicesAny medical device is exempted from registration under section 5 of the Act by the Minister
Malaysia: MDA Announced Medical Device (Exemptions) Order of 2024 Read More »
To further develop the Philippines Food and Drug Administration’s (FDA) processes and automation of their system for initial, renewal and variation applications for the License to Operate (LTO) through the FDA eServices Portal System, the FDA proposed revisions on the documentary and other technical requirements for LTO applications to be abreast with internationally acceptable standards.
On February 19, 2024, the Medical Device Authority (MDA) of Malaysia released a draft guidance regarding the Placement of HIV Self-Test (HIVST) Kit in the Malaysian market. This guidance, identified as MDA/GD/0065, aims to provide direction for businesses interested in importing, exporting, or placing the Human Immunodeficiency Virus Self-Test kit (HIVST) in Malaysia. This document,
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