Country Guides

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.

Review updated EMA guidance on mechanistic model reporting and qualification when published; align sponsor submissions with new qualification pathways and reporting requirements for MIDD and safety-related models.