Regulatory Affairs Newsletter Archive – Page 175

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TGA phases out ISO 13485 certificates for IVD devices

The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for IVD devices has ended on 26 May 2023. TGA no longer accepts these certificates to support IVD applications. More information on this can be found here.

adminJune 8, 2023

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Export health certification for inedible animal products

The amended UK model health certificates, which incorporates the changes published in October/December 2022, are now active and available for use. More information on this can be found here.

adminJune 8, 2023

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New BSI standard for international environmental management

A new standard BS EN ISO 14002-2:2023 Environmental management systems — Guidelines for using ISO 14001 to address environmental aspects and conditions within an environmental topic area — Part 2: Water has been added to the international environmental management series. This document uses the BS EN ISO 14001 framework to address issues related to water. It focuses on both how…

adminJune 8, 2023

HMRC weekly update (WC 29 May)

Please note this is an extract of the original bulletin. Transit newsletters – HMRC updates Page summary: Check for the latest updates about moving goods using transit and the New Computerised Transit System (NCTS). Change made: The new newsletter ‘May 2023 – Update on NCTS Phase 5: how to amend rejections’, explaining how the NCTS5 web portal will allow…

adminJune 8, 2023

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Cabinet Office weekly update (WC 29 May)

Please note this is an extract of the original bulletin. The Border Target Operating Model: Draft for Feedback Page summary: This page contains the draft Border Target Operating Model, setting out a new approach to importing into Great Britain that will be progressively introduced from the end of October 2023. Change made: Updated with next steps now engagement period…

adminJune 8, 2023

DEFRA weekly update (WC 29 May)

Please note this is an extract of the original bulletin. Environment Agency consults on Drax carbon capture plans Page summary: The Environment Agency is encouraging the local community to attend community events to give their views. Change made: First published. Licensed waste facilities that accept waste F gas and ODS Page summary: A list of waste facilities that accept waste…

adminJune 8, 2023

OPSS weekly update (WC 29 May)

Please note this is an extract of the original bulletin. Designated standards: low voltage Page summary: Notices of publication and a consolidated list for designated standards for low voltage electrical equipment. Change made: Notice of publication amended and consolidated list updated. UK Market Conformity Assessment Bodies service redesign Page summary: New UKMCAB service launched with enhanced functionality and appearance following…

adminJune 8, 2023

BEIS weekly update (WC 29 May)

adminJune 8, 2023

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DBT weekly update (WC 29 May)

Please note this is an extract of the original bulletin. UK-New Zealand FTA origin declaration Page summary: Origin declaration guidance for trade under the terms of the UK-New Zealand free trade agreement (FTA). Change made: First published. UK-New Zealand FTA: provisions for small and medium-sized enterprises (SMEs) Page summary: List of relevant provisions for SMEs in the UK-New Zealand free…

adminJune 8, 2023

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DHSC weekly update (WC 29 May)

Please note this is an extract of the original bulletin. SaBTO virology subcommittee recommendations on KSHV infection Page summary: Recommendations to introduce universal serological screening of deceased donors for Kaposi’s sarcoma-associated herpesvirus (KSHV) infection. Change made: First published. SaBTO reports and guidance documents Page summary: Reports published by the advisory committee on the Safety of Blood, Tissues and Organs (SaBTO).…

adminJune 8, 2023