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Regulatory Affairs Newsletter Archive

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
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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
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Dynamic list of standards applicable to IVDs, in collaboration with BSI

BIVDA have collaborated with BSI to develop a comprehensive list of relevant standards that relate to various aspects of IVD product development and manufacturing. We have worked jointly with BSI to compile this list of IVD Standards to help BIVDA members identify those standards relevant to IVD products and organisational needs. While the list aims to provide a clear and…
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September 1, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Intertek designated as a UK Approved Body

Recently MHRA announced the designation of TUV Rheinland UK Ltd and TUV SUD BABT Unlimited under the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). On 24 August, their webpage was updated again to add the designation of Intertek Medical Notified Body UK Ltd for medical devices. Approved bodies are organisations which the MHRA…
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August 25, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 14 Aug)

Please note this is an extract of the original bulletin. How to claim preferences under the Developing Countries Trading Scheme (DCTS) Page summary: This guidance outlines the requirements for claiming preferential tariffs under the Developing Countries Trading Scheme (DCTS). Change made: Removed importers knowledge from the list of types of proof of origin.
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August 25, 2023
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