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Takeaways from AI Impact Summit & The Philippines Join Global Regulatory Network

Takeaways from the AI Impact Summit 2026 and HealthAI Welcomes Newest Global Regulatory Network Member News from Manila and Notes from New Delhi: Towards a bolder, more inclusive future   Last month in New Delhi, I had the opportunity to attend the AI Impact Summit 2026, a milestone moment not only for global AI governance but also for the future…
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March 23, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Therapeutic Goods (Information Specification – Database of Recalls, Product Alerts and Product Corrections) Instrument 2025

Dear Members, TGA have updated their information specification for their recalls and product alerts and corrections database. Therapeutic Goods (Information Specification – Database of Recalls, Product Alerts and Product Corrections) Instrument 2025 This Specification facilitates the release of specified therapeutic goods information held by the TGA in the database known as the Database of Recalls, Product Alerts and Product Corrections…
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March 19, 2026
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TGA Software based medical device exclusion guidance

Dear Members, TGA has posted Guidance on Software based medical device exclusions for specific uses. Software-based medical device exclusions | Therapeutic Goods Administration (TGA) TGA – Guidance - Understanding the health facility management software exclusion - Guidance on when software used for the administration or management of health processes or facilities may be excluded from our regulatory requirements. View article...…
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March 19, 2026
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The Digital Markets, Competition and Consumers Act 2024 (Commencement No. 3 and Transitional Provisions) Regulations 2026

Dear members, the implementation legislation below impacts the provision of alternative dispute resolution under the Digital Markets and Competition and Consumer Protection Act 2024. The Digital Markets, Competition and Consumers Act 2024 (Commencement No. 3 and Transitional Provisions) Regulations 2026 These Regulations bring into force Chapter 4 of Part 4 and Schedules 25 to 27 of the Digital Markets, Competition…
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March 19, 2026
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Commissioner Várhelyi to open high-level event on medical devices

Commissioner Várhelyi to open high-level event on medical devices Next Monday 16 March, EU Commissioner for Health and Animal Welfare Olivér Várhelyi will open a high-level conference in Brussels on “Medical Devices: Innovation and Patient Safety”. The event, hosted by the Commission under the auspices of the Cypriot Presidency of the Council, will bring together a wide range of industry,…
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March 19, 2026
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EN IEC 60445:2021/A1:2026 – Basic and safety principles for man-machine interface, marking and identification – Identification of equipment terminals, conductor terminations and

Updated electrical safety standard EN IEC 60445:2021/A1:2026 - Basic and safety principles for man-machine interface, marking and identification - Identification of equipment terminals, conductor terminations and conductors (publication date=2026-03-13) View article...
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March 19, 2026
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