You can find the updated (Rev 6, July 2025) Guidance GN-21 from HSA Singapore on Medical Device Change Notification here.
Ben KempJuly 10, 2025
NMPA China have published a list of updated Medical Device Standards including some for IVDs including: 15 - 17α-Hydroxyprogesterone Assay Kit (Labelled Immunoassay) 17 - Information provided by the manufacturer of the medical device 18 - Motor Neuron Survival Gene (SMN) Assay Kit 19 - Aldosterone Assay Kit (Chemiluminescence Immunoassay) 20 - Colorectal Cancer-relate d Gene Methylation Detection Kit (Fluorescent…
Ben KempJuly 10, 2025
This guidance has been updated by the Australian Government and can be found here.
Ben KempJuly 10, 2025
Are you looking for a concise yet comprehensive overview of the most impactful state-level data protection laws affecting US businesses right now? The advancement of technology has amplified the need for robust data protection, and with 144 countries already having national privacy laws, the US states are rapidly catching up. We've developed a crucial resource to help you…
Ben KempJuly 4, 2025
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
You can find the document here.
Ben KempJuly 4, 2025
FDA have announced a number of reclassifications of Class III devices to lower classifications such as Class II ( with special controls). These include: muscular dystrophy newborn screening tests herpes simplex virus nucleic acid-based assay for central nervous system infections fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies lysosomal storage disorder newborn screening test systems.
Ben KempJuly 4, 2025
Please note that this consultation closes 11th August 2025. The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing…
Ben KempJuly 4, 2025
Please see this list of FDA consensus standards (updated last month). Of note are the items below including AAMI TIR45 on AGILE practices in software development, and the updated Common Vulnerability Scoring System (CVSS), noting that both 3.1 and 4.0 are recognised, but that the period for which 3.1 is recognised is 7 months then 4.0 is recognised. As usual,…
Ben KempJuly 4, 2025
NEW — CLSI EP46 Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures CLSI EP46 provides models and approaches for setting allowable total error (ATE) goals and limits, helping developers and laboratories define acceptance criteria for quantitative test methods. This essential resource covers: Approaches for determining ATE based on clinical outcomes, biological variation, and…
Ben KempJune 26, 2025