In the first quarter of 2024, The Department of Infrastructure and Medical Equipment released Decision No. 166/QĐ-BYT and Decision No. 490 / QĐ-BYT regarding the issuance of criteria and principles for assessment of the general technical documentation for Non-In Vitro and In-Vitro Medical Devices following ASEAN regulations (CSDT). They have
The Procurement Goods/Services (LKPP: Lembaga Kebijakan Pengadaan Barang dan Jasa Pemerintah) under the Indonesia Ministry of Health announces the updated timeline for the e-Catalogue listing has been extended until 30 June 2024. Stakeholders can still list their products in the e-Catalogue during the timeline announced until further notice. With regard
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
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
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
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
Subscribe to our Newsletter
Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!
