Pakistan’s Competent Authority has published revised fees: S.R.O. 1324(l)12024 – Revision of Regulatory Fee Notification – Drug Regulatory Authority of Pakistan (dra.gov.pk)
Ben KempSeptember 18, 2024
MHRA consultation on statutory fees – proposals on ongoing cost recovery Page summary: Consultation on proposals to update the MHRA’s statutory fees to ensure they continue to recover their costs. Change made: Following early feedback from customers and stakeholders, we have clarified some terms in the consultation document relating to Priority 2: The MHRA proposes to amend its existing Medical…
Ben KempSeptember 18, 2024
ICAI review of DHSC's aid-funded global health research and innovation: government response Page summary: The UK government response to the Independent Commission for Aid Impact’s July 2024 recommendations on DHSC’s aid-funded global health research and innovation. Change made: First published. Time updated: 12:26pm, 10 September 2024 PM: ‘Major surgery, not sticking plaster solutions' needed to rebuild NHS Page summary: The…
Ben KempSeptember 18, 2024
Joint minutes of the first UK-New Zealand Environment and Climate Change Sub-Committee Page summary: A summary of the discussions from the first UK-New Zealand Environment and Climate Change Sub-Committee including key points and recommendations. Change made: First published. Time updated: 2:18pm, 9 September 2024 UK, US and Australia sign supply chain resilience pact Page summary: The United Kingdom, United States…
Ben KempSeptember 18, 2024
South Korea: UK Science and Innovation Network summary Page summary: A summary from UK Science and Innovation Network (SIN) on science and innovation in South Korea including UK SIN priorities and successes. Change made: The ‘South Korea: UK Science and Innovation Network Summary’ has been updated. Time updated: 7:26am, 11 September 2024 Data centres to be given massive boost and…
Ben KempSeptember 17, 2024
Team NB have developed a position paper and template for the transfer of surveillance of legacy devices. This tripartite agreement template is regarding the transfer of responsibilities between notified bodies for certified IVD legacy devices subject to transitional arrangements, under the EU IVDR Article 110 You can find the paper here.
Ben KempSeptember 17, 2024
These Regulations amend the Relief for Research and Development (Content of Claim Notifications, Additional Information Requirements and Miscellaneous Amendments) Regulations 2023 to restate the information that has to be provided by a company claiming relief from corporation tax in respect of expenditure on research and development (“R&D”). The changes they make reflect significant reforms to the R&D regime made by…
Ben KempSeptember 17, 2024
The Regulatory Affairs Seminar will be held on the 11th and 12 February 2025. BIVDA’s Regulatory Affairs Seminar brings together the UK’s leading regulatory specialists to learn and collaborate. Next year’s event is being held at the Grand Hotel, Birmingham. Tickets are available at £895 per ticket, the event is currently NOT on Eventbrite so please signal your interest by…
Ben KempSeptember 17, 2024
There is now the choice of 13 designated notified bodies for the IVD Regulation as articulated here.
Ben KempSeptember 11, 2024
Dear Members, MedTech Europe have drafted a manufacturers declaration to Regulation (EU) 2024/1860, the latest IVD regulation transitional legislation. The declaration can be used to support the continued use of IVD Directive Certificates that have expired, but where the manufacturer continues to meet the requirements of the updated legislation and Article 110 of the IVD Regulation 2017/746. To: Regulatory Affairs…
Ben KempSeptember 11, 2024