Register medical devices to place on the market Page summary: How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland. Change made: Updated fees implementation and management guidance, to correct minor typos only, no change to content.Updated link to survey on fees implementation and management guidance Time updated: 3:52pm, 5 November 2025
Ben KempNovember 6, 2025
Medicines Supply Security Committee Inquiry The Public Services Select Committee is carrying out an inquiry to understand the causes of medical shortages and the ability to predict and prevent medicine shortages that are currently putting significant pressure on the Health Sector. These shortages impact the direct health of patients and put the NHS, Pharmacies and GPs under increased pressure. The aim of…
Ben KempNovember 6, 2025
The Therapeutic Goods Administration (TGA) has updated its Advertising therapeutic goods on social media guidance to help advertisers to understand their responsibilities when promoting therapeutic goods via these platforms. While social media offers powerful opportunities for consumer engagement, any content that promotes the use or supply of therapeutic goods is considered advertising and must comply with regulatory requirements under the Therapeutic Goods…
Ben KempNovember 6, 2025
Reprocessing and Exporting UK packaging waste Register now for the Reprocessors and Exporters Webinar Defra, in collaboration with the regulators, are hosting a webinar for reprocessors and exporters of UK packaging waste on Tuesday 11 November at 2pm. Please register now. The topics we plan to cover in this webinar include: The summary log Raising and issuing PRNs Onboarding to…
Ben KempNovember 6, 2025
Dear members, please see below call for comments. If you're impacted by this call, please let me know at regulatory@bivda.org.uk. Imidazole hydrobromide is used in optoelectrical components including LEDs. 1-methylimidazole acts as a solvent and catalyst in the production of pharmaceuticals, coatings, and polymers, as well as a curing agent for epoxy resins and a building block for ionic liquids…
Ben KempNovember 6, 2025
Dear members, following on from the good news that ISO TC 210 WG had reconfirmed ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, meaning that it remains unchanged until April 2030, two other updates have been received. The guidance on the implementation of ISO 13485 will be updated and released as ISO TS 23485 in…
Ben KempNovember 6, 2025