On July 5, 2023, TMDA released a draft of Guidelines for handling unfit Medical Devices and diagnostics.
These comprehensive guidelines offer valuable insights into the proper procedures for withdrawing and recalling unfit medical devices and diagnostics, considering relative health risks and potential adverse events or incidents that may affect patients or users.
The purpose of their notice is to inform the public that TMDA is inviting comments on this draft guidelines to help finalize it. For more information and to share your comments, visit the TMDA website.
The Guidelines will be available for comments until 30th August 2023.