On March 31, 2025, the World Health Organization (WHO) issued an advisory regarding performance concerns with certain malaria rapid diagnostic test kits (RDTs). WHO has received multiple reports indicating faint positive test lines observed in patients confirmed to have malaria, potentially affecting test reliability across several countries using these kits.
On April 17, 2025, the Food and Drug Administration (FDA) recognized the importance of enhancing competitiveness by developing public administration systems to provide efficient services to the public. Therefore, the electronic certificate system (e-Certificate) has been developed to meet the needs of entrepreneurs, allowing them to access services online anytime and
On 26 March 2025, the Medical Device Authority (MDA) announced the implementation of Circular Letter No. 1/2025, which supersedes Circular Letter No. 2/2014 regarding conformity assessment procedures for medical devices approved by recognised foreign regulatory authorities. This new circular was approved by the MDA Board and Top Management and took
The Medical Device Authority (MDA) of Malaysia has released the Second Edition Guidance Document, MDA/GD/0051 April 2025: Medical Device for the Purpose of Export Only, for public comment. This document is intended to replace the previous edition MDA/GD/0051 April 2019: Notification of Export Only Medical Device. The revised guidance provides comprehensive
The Medical Device Authority (MDA) of Malaysia has released the Second Edition Guidance Document, MDA/GD/0043 Mei 2025: Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, for public comment. This document is intended to replace the previous edition, MDA/GD/0043 May 2020: Special Access – Notification – General
On 21 April 2025, the Directorate General of Pharmaceuticals and Medical Devices of the Ministry of Health of Indonesia issued a new Circular Letter updating the approved list of laboratories for testing medical devices and health supplies under the SNI ISO/IEC 17025:2017 standard. The updated regulation is detailed in Circular
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