Full Implementation of Notification for Orphaned, Obsolete, and Discontinued Medical Devices

The Medical Device Authority (MDA) is pleased to announce the upcoming implementation of the Notification of Orphaned, Obsolete, and Discontinued Medical Devices, set to be fully operational in November 2024. This initiative aims to ensure that all facilities effectively manage these categories of medical devices, maintaining patient safety and regulatory compliance.

 

Key Dates and Countdown:  Timeline_OOD_1.jpeg

 

Suggestion Framework (Updated version, will be notified): Framework_OOD_1.jpeg

 

Guidance is expected to be available by September 2024. To ensure smooth compliance, AR or facilities should take the following steps:

  1. Identify all orphaned, obsolete, and discontinued medical devices in your inventory.
  2. Begin gathering necessary documentation, such as manufacturer declaration letters or proof of ceased operations.

Beginning in November 2024, AR/ facilities can start submitting notifications to the MDA using the designated form via email. Thank you for your cooperation in ensuring a seamless transition to the new notification process.

Any inquiries, please email to : [email protected]

Updated: 26th June 2024