AI IMPACT ASSESSMENT TOOL PUBLISHED: WHAT MEDICAL DEVICE MANUFACTURERS NEED TO KNOW
TGA, 27 December 2025 – The Digital Transformation Agency (DTA) has officially published the AI Impact Assessment Tool (v1.0) and the updated Policy for the responsible use of AI in government. While this framework is designed for Australian Government agencies, it acts as a mandatory “gatekeeper” for procurement. If a government agency intends to use […]
MEDICAL GAS CGMP GUIDANCE PUBLISHED : WHAT MANUFACTURERS NEED TO KNOW
FDA, 27 DEC 2025 — The FDA has released its long-awaited Draft Guidance on Current Good Manufacturing Practice (CGMP) for Medical Gases, signaling a major shift from “one-size-fits-all” drug rules to a tailored regulatory framework., Medical gas manufacturers have operated under general drug regulations (21 CFR Parts 210 and 211) that were designed for pills […]
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