New resources on market actions and minor PRAC updates Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New resources on market actions and minor PRAC updates

Dear Members, TGA Australia have issued New resources on market actions and minor PRAC updates We have published a new FAQ and Guidance page on the use of legislative powers related to recalls and other market actions. View article...
Ben Kemp
February 27, 2026
Use of legislative powers related to recalls and other market actions Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Use of legislative powers related to recalls and other market actions

Dear Members, TGA Australia have issued an update on use of legislative powers related to recalls and other market actions Guidance to help sponsors understand the legislative powers the TGA can use relating to market actions. View article...
Ben Kemp
February 27, 2026
MedTech Europe – Clinical evidence requirements ebook fourth edition published MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MedTech Europe – Clinical evidence requirements ebook fourth edition published

Dear Members, if you’re not already aware, MedTech Europe published the 4th Edition of the Clinical Evidence Guidance available to download from: Clinical Evidence Requirements for CE certification - MedTech Europe.
Ben Kemp
February 27, 2026
WHO Position Note on Accessories Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

WHO Position Note on Accessories

Dear Members, WHO has issued a Position Note on Accessories Position Note on Accessories Published | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control) This provides guidance regarding accessories supplied with WHO Pre-Qualified Devices.
Ben Kemp
February 27, 2026
NICE – Statement of intent – NICE’s approach ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

NICE – Statement of intent – NICE’s approach ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds

Dear members, please see below update from NICE - Statement of intent - NICE's approach ongoing evaluations ahead of proposed changes to NICE's standard cost-effectiveness thresholds. Overview | Statement of intent on NICE’s approach to ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds | Guidance | NICE
Ben Kemp
February 27, 2026