Please find here second edition of the IMDRF 2025 Implementation report. This provides an overview of the degree to which IMDRF Guidance etc. has been applied to the regulatory frameworks of the IMDRF member countries.
Ben KempSeptember 8, 2025
New EU active substance approval decision Apply for product authorisation to access the NI market. Following evaluation under the EU Biocidal Products Regulation (EU BPR), a decision has been taken to approve the following active substance/product type combination. This will affect NI: 1 August 2025 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride (CAS 26172-54-3 EC 247-499-3) in product type 6 Action for biocidal product suppliers…
Ben KempSeptember 8, 2025
You can find the latest information here: https://www.sahpra.org.za/wp-content/uploads/2025/08/COMM-Issue-No.-MD07_2025_26-v2-2.pdf
Ben KempSeptember 8, 2025
You can find the latest information here: https://www.tga.gov.au/resources/guidance/reporting-medical-device-adverse-events-healthcare-facilities
Ben KempSeptember 8, 2025
You can find the Australian Government's release here: https://www.tga.gov.au/resources/guidance/understanding-regulation-software-based-medical-devices
Ben KempSeptember 8, 2025
Health Canada have updated/published their Guidance for determining medical device application type: This document provides guidance to medical device manufacturers on the different application types listed in the Medical Devices Regulations, including how to determine when medical devices can be combined and submitted as one application. View article...
Ben KempSeptember 8, 2025
Upcoming GB active substance renewal submission deadline Apply for active substance renewal by the deadline to keep products on the GB market. Under the GB Biocidal Products Regulation (GB BPR), active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date. The 550-day deadline is coming up for the following active substance/product…
Ben KempSeptember 8, 2025