Outcome and Implementation plan from the MDA-CAB 2024 Workshop:

  1. Amendment Phase (April 1, 2024 - April 30, 2024)
  • Purpose: Update CAB procedures to align with new templates and processes, make necessary amendments, and conduct internal training.
  1. Pilot Phase (May 1, 2024 - October 23, 2024)
  • Purpose: Test and familiarize with the new GDPMD and Verification Report Templates and TAT, identify potential issues, and gather the feedback.
  1. Full Implementation Phase November 1, 2024 (Subject to the decision in MDA-CAB Workshop 2024 (Series II) on October 24, 2024
  • Purpose: Integrate the GDPMD and Verification Report Templates and TAT into standard operating procedures after thorough testing and refinement.
  • Refinement Dates: October 24, 2024 - October 31, 2024

 

During the pilot phase, the MDA-CAB 2024 Workshop also introduced the Conformity Assessment Report for the product verification route.

 

 

References:

IMPLEMENTATION OF MDA-CAB WORKSHOP 2024 OUTCOMES

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