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Regulatory Affairs Newsletter Archive

Customs Declaration Service: announcement of phased approach for exports UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Customs Declaration Service: announcement of phased approach for exports

HMRC announced a staged approach to the deadline to move across to the Customs Declaration Service (CDS) for exports to allow businesses more time to prepare and ensure IT is thoroughly tested. Some businesses may still be able to start making export declarations through CDS by Thursday 30 November 2023.  All other export declarations should be made through CDS by…
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September 8, 2023
Public consultation on disclosure of industry payments to the healthcare sector UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Public consultation on disclosure of industry payments to the healthcare sector

The Department of Health and Social Care (DHSC) has launched a public consultation on disclosure of industry payments to the healthcare sector. The consultation seeks views on the possible introduction of new secondary legislation. This legislation would place a duty on manufacturers and commercial suppliers of medicines, medical devices and borderline substances to report details of the payments and other…
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September 8, 2023
MHRA weekly update (WC 28 Aug) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 28 Aug)

Please note this is an extract of the original bulletin. Three new UK Approved Bodies to certify medical devices announced by the MHRA Page summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new UK Approved Bodies, almost doubling the UK’s capacity to certify medical devices, supporting faster certification of safe and effective medical devices for healthcare…
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September 8, 2023
Publication of the MDR and IVDR Communication Survey (deadline September) European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Publication of the MDR and IVDR Communication Survey (deadline September)

The European Commission recently launched a “MDR and IVDR Communication Survey” as part of their “Communication campaign on MDR and IVDR(HS-p-22-19.04, 06, 07, 08, 09, 10 and 11)”. The objective of the survey is to better understand the information needs around the MDR and IVDR, how the changes in the legislation are affecting directly involved stakeholders, and what challenges stakeholders…
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September 1, 2023
DHSC weekly update (WC 21 Aug) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 21 Aug)

Please note this is an extract of the original bulletin. Major conditions strategy: case for change and our strategic framework Page summary: Ahead of the government’s forthcoming major conditions strategy, this report sets out our approach to tackling the groups of conditions that drive ill health in England. Change made: Inserted the text ‘The Rt Hon Steve Barclay MP, Secretary…
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September 1, 2023
MHRA weekly update (WC 21 Aug) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 21 Aug)

Please note this is an extract of the original bulletin. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: COVID-19 test validation approved products spreadsheet updated. Medical devices: UK approved bodies Page summary: UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Change made:…
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September 1, 2023
DBT weekly update (WC 21 Aug) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 21 Aug)

Please note this is an extract of the original bulletin. Notice to exporters 2023/17 : a compound settlement Page summary: UK company fined in relation to the unlicensed trade of goods in breach of The Russian (Sanctions) (EU Exit) Regulations 2019. Change made: First published. Notices to exporters Page summary: Notices to exporters published by the Export Control Joint Unit…
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September 1, 2023
U.S. FDA weekly update (WC 28 Aug) FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 28 Aug)

Please note this is an extract of the original bulletin. FDA to update AccessGUDID Database and OpenFDA The U.S. Food and Drug Administration (FDA) updated the fields released in the public AccessGUDID Database to include the field for Global Medical Device Nomenclature (GMDN) Code along with the status of the GMDN Code, Active or Obsolete. These new fields are available…
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September 1, 2023
Brazilian regulator ANVISA amends medical device import law Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Brazilian regulator ANVISA amends medical device import law

On 18 August, Brazil’s medical device regulator ANVISA issued RDC No. 810/2023 to amend Article 60 of RDC No. 751/2022: Notification and Registration of Medical Devices. This amendment allows medical devices and accessories to be imported into Brazil if manufacture date precedes registration date. Brazil’s Import Manual was also updated to reflect this amendment. More information on this amendment can be found here.…
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September 1, 2023