Sponsors must align their products with the updated safety and formulation requirements for permissible ingredients as per the new determination.
Tga update requires triage for Label Governance, Signal Validation, Risk Management; confirm local obligations and document follow-up actions.
Mhra update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.
This update requires triage for Label Governance, Signal Validation, Risk Management; confirm local obligations and document follow-up actions.
Ema update requires triage for Label Governance, Risk Management, AI / GxP Governance; confirm local obligations and document follow-up actions.
Sponsors and MAHs must replace the 2021 form with the new 2026 approved form for all six-monthly reports on unapproved therapeutic goods supplied under SAS and CTA schemes.
Review the guidance to ensure compliance with post-marketing safety reporting timelines and annual report submissions; update SOPs for ICSR processing and periodic report generation.
Identify which unclassified medical devices are affected by the exemption; update regulatory submissions and post-market surveillance plans accordingly; ensure compliance with general controls and post-market surveillance obligations.
