The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 20 September These include updates on news, including regulatory updates, transitional guidance and events.
adminSeptember 29, 2023
Please note this is an extract of the original bulletin. CDRH Issues Updated Final Guidance on the Breakthrough Devices Program The U.S. Food and Drug Administration (FDA) issued an update to the final guidance: Breakthrough Devices Program. The updates align with the actions outlined in the FDA’s Center for Devices and Radiological Health (CDRH) Strategic Priorities to Advance Health Equity…
adminSeptember 29, 2023
Please note this is an extract of the original bulletin. Business regulation: statutory review requirements Page summary: Guidance for departments on what they need to consider when deciding whether a review provision is appropriate. Change made: Added new statutory guidance. Smarter regulation Page summary: This page sets out how the UK government’s smarter regulation programme seeks to reduce burdens on…
adminSeptember 29, 2023
Please note this is an extract of the original bulletin. Packaging data: what to collect for extended producer responsibility Page summary: A guide to collecting data about your packaging. This is for UK organisations affected by extended producer responsibility (EPR) for packaging. Change made: An update to match regulations: where packaging is described as ‘imported, emptied and then discarded’, that’s…
adminSeptember 29, 2023
Please note this is an extract of the original bulletin. Export animal derived peptones to Canada: certificate 8806 Page summary: Apply online to export animal derived peptones to Canada. Change made: First published. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products…
adminSeptember 29, 2023
Please note this is an extract of the original bulletin. Search the register of customs agents and fast parcel operators Page summary: Find a customs agent or fast parcel operator to help you with import and export declarations. Change made: The list of customs agents has been updated with one amendment.
adminSeptember 29, 2023
Please note this is an extract of the original bulletin. The Innovative Devices Access Pathway (IDAP) Page summary: The Innovative Devices Access Pathway (IDAP) program is designed to accelerate the development of cost-effective medical devices and their integration in to the UK market. Change made: First published. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List…
adminSeptember 29, 2023
Please note this is an extract of the original bulletin. The disclosure of industry payments to the healthcare sector Page summary: This consultation aims to seek views on the possible introduction of regulations mandating the disclosure of industry payments to the healthcare sector. Change made: Updated table 1 to clarify that there are only some payment reporting requirements and retention…
adminSeptember 29, 2023
Please note this is an extract of the original bulletin. Section 70: Weights and Measures returns and reports Page summary: Local Weights and Measures Authority reports and returns on enforcement work over a 12 month period. Change made: Report and local authority returns added for 2022 to 2023. Weights and Measures report published Page summary: OPSS publishes the 2022-23 Section…
adminSeptember 29, 2023
Please note this is an extract of the original bulletin. New advisory service to help businesses launch AI and digital innovations Page summary: Businesses across the UK will have the opportunity to showcase that their new AI and digital innovations comply with regulatory standards, so they can quickly bring them to market. Change made: First published.
adminSeptember 29, 2023