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UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA and international partners publish guiding principles for machine learning-enabled medical devices

MHRA, U.S. Food and Drug Administration (FDA) and Health Canada have jointly released 'Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles' In this document, MHRA, FDA and Health Canada have jointly identified 5 guiding principles for predetermined change control plans (PCCP). These principles draw upon the Good Machine Learning Practice (GMLP) guiding principles. PCCPs provide a new…
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October 27, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 09 Oct)

Please note this is an extract of the original bulletin.   Government launches review of regulators to cut red tape and bureaucracy Page summary: Review set up to cut burdens for businesses in new post-Brexit regulatory framework and improve customer outcomes Change made: First published. Smarter regulation Page summary: This page sets out how the UK government’s smarter regulation programme…
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October 27, 2023
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

TGA medical devices vigilance program pilot

The TGA is commencing a 12-month pilot of the new Medical Devices Vigilance Program. Sponsors who have medical devices included in the Australian Register of Therapeutic Goods can volunteer for the pilot. The pilot is designed to support medical device sponsors comply with regulation and give the public confidence that sponsors are meeting their responsibilities. More information on this program…
admin
October 27, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 09 Oct)

Please note this is an extract of the original bulletin. Government to invest £30 million in innovative technology for NHS* Page summary: Applications are now open for Integrated care systems to apply for a share of £30 million to roll out innovative technology Change made: The press release has been updated as applications are now open for ICSs to bid…
admin
October 27, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 16 Oct)

Please note this is an extract of the original bulletin. New innovation challenge launched to tackle bias in AI systems Page summary: UK companies can apply for up to £400,000 in government investment to fund innovative new solutions which tackle bias and discrimination in AI systems. Change made: First published. DSIT cyber security newsletter – October 2023 Page summary: The…
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October 27, 2023
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