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

DSIT weekly update (WC 31 July)

Please note this is an extract of the original bulletin. 5G Innovation Regions Page summary: A £40 million fund for local and regional authorities across the UK to establish themselves as ‘5G Innovation Regions’. Change made: First published. £40 million fund launched to unlock 5G benefits across the UK Page summary: The government has launched a £40 million fund to…
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August 11, 2023
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

TGA publishes new guidance on manufacturer evidence for IVD medical devices

Following the phase out of ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, the TGA have published a guidance that helps sponsors to transition to using another form of manufacturer evidence to ensure ongoing regulatory compliance. The new guidance can be found here.
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August 11, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 31 July)

Please note this is an extract of the original bulletin. Using the UKCA marking* Page summary: Find out if you need to use the UKCA (UK Conformity Assessed) marking on products you manufacture or handle. Change made: Updated the ‘call to action’ banner before the main body of text, to list the sectors the CE marking will continue to apply…
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August 11, 2023
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

Proposal for new ISO Technical specification on sequencing and clinical application to infectious diseases

The BSI CH/212 IVDs group is responsible for standardization in the field of in vitro diagnostics (IVDs). They have put forward a proposal to develop a new technical specification, ISO/PWI TS 8219: Sequencing and clinical application to infectious diseases. The document covers the essential requirements for advanced sequencing procedure for detecting the microbes directly, without the need for microbial culture.…
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August 4, 2023