Dear members, please let me know via regulatory@bivda.org.uk any feedback to the TGA Australia - Proposed amendments relating to transparency of disruptions to supply of medical devices. Consultation closes 20th Feb 2026. TGA want your feedback on the proposed changes to improve transparency about disruptions to the supply of medical devices. Consultation: Improved sharing of information about medical…
Ben KempJanuary 15, 2026
Please see below update from the International Serum Industry Association, regarding intensified official controls and imposed checks at EU borders impacting Animal By-products INTERNATIONAL SERUM INDUSTRY ASSOCIATIONINTERNATIONAL SERUM INDUSTRY ASSOCIATION1,309 followers1,309 followers Reminder: Intensified Official Controls and Imposed Checks On 9 December the European Commission announced a reinforcement of controls on food, animal and plant products entering the EU. The…
Ben KempJanuary 12, 2026
Dear Members, please be advised that TGA Australia are running a consultation on the Conformity Assessment Procedures for medical devices – proposed amendments. The consultation closes 27th Feb 2026. Please provide any feedback to regulatory@bivda.org.uk This is particularly relevant as TGA Australia is a proposed jurisdiction that will be recognised by the MHRA for international reliance, under the proposed changes…
Ben KempJanuary 12, 2026
Dear Members, IMDRF issued its 2026-2030 strategic plan. The strategic plan outlines the mission, objectives, and priorities of the International Medical Device Regulators Forum (IMDRF). This directly and indirectly impacts BIVDA members, one by setting the guidance that a number of key regulators base their legislative principles on, and also increasingly by setting the minimum requirements that allow international reliance…
Ben KempJanuary 12, 2026
Dear Members, NMPA - China have updated their Medical Device GMP requirements, and this will apply from 1st November 2026 Revision and Release of the Good Manufacturing Practice for Medical Devices
Ben KempJanuary 12, 2026
SHEILD up! Launch of EUR 25 million project to prevent infections from developing into cancer Every year, more than two million people in Europe develop cancer, and one in eight of these cancer cases are caused by an infection that could have been prevented. The SHEILD Joint Action (Strategies for Health Interventions to Eliminate Infection related Cancers) launched today in…
Ben KempJanuary 12, 2026
Exporters holding certain Open General Licences (OGLs) will have received automatic requests from SPIRE to complete their annual returns for 2025. Before you submit your return, check the following: Select the correct reporting period (01-JAN-25 to 31-DEC-25) • Usage count must be entered accurately. • Surrender any licences no longer in use after submitting returns. The Open Licence Returns guidance…
Ben KempJanuary 12, 2026
Dear members, TGA - Australia are promoting the Reporting of issues with medicines and medical devices to help make them safer. Have you experienced an issue with a medicine or medical device? Every report is important. Reports help us monitor the safety of medicines, vaccines and medical devices. View article...
Ben KempDecember 12, 2025
Varying entries in the ARTG: medical devices and IVDs This user guide is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device. View article...
Ben KempDecember 12, 2025