The Health Sciences Authority (HSA) of Singapore announced regulatory fees revision pertaining to health products including medical devices, to be effective on 1 July 2024. The HSA continues to absorb the 1% Goods and Services Tax (GST) increment which was implemented on 1 Jan 2023 and 1 Jan 2024, until
On December 29, 2023, PFDA issued Circular No. 2023-012, listing Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services. Aligned with DOH AO No. 2020-0035, PFDA oversees facilities using radiation devices to safeguard workers. Emphasizing adherence, PFDA requires providers to establish formal procedures for approval, recognition, or authorization
On 15 December 2023, Health Sciences Authority (HSA) Singapore issued a medical device advisory to alert industry stakeholders to cybersecurity vulnerabilities known as “5Ghoul”. “5Ghoul” affects commercial off-the-shelf (COTS) edge devices using 5G modems. Medical device systems using 5G modems for internet connectivity to function could be attacked in the
The Center for Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (Philippines) have announced that they will be conducting an inventory and processing of the pending applications for registration of medical devices. In line with this, FDA Philippines has declared an application holiday for CMDN
On December 14th, 2023, the Medical Device Authority (MDA) of Malaysia issued a requirement for surveillance report on implantable medical devices on the homepage of Medcast 2.0+ system. This requirement applies to distributors in which as per clause 27.(1) until 27.(3) in GDPMD, establishments that distribute implantable medical devices shall
On December 12th, 2023, the MDA issued 2 (two) guidance documents as follows: MDA/GD/0062 Harmonised Classification of Medical Devices in ASEAN, Second Edition. MDA/GD/0063 Harmonised Borderline Products in ASEAN, Second Edition. These are the highlights of each regulation: Harmonised Classification of Medical Devices in ASEAN 2nd Edition (MDA/GD/0062) Harmonised Borderline
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