Public Comment Draft Guidance Document Control of Obsolete and Discontinued Medical Device in Healthcare or Related Facilities

Malaysia’s Medical Device Authority Guidance on Obsolete and Discontinued Medical Devices

TheMedical Device Authority  in Malaysia  has released a guidance document on the management and exemption  of obsolete and discontinued medical devices  in healthcare settings. Key points include:

Criteria for Device Status Confirmation : Establishments must confirm the status of devices as obsolete or discontinued based on specific criteria outlined in the Medical Device (Exemption) Order 2024 .

Application Process : 

• Complete the application forms and provide necessary supporting documents .
• Pay processing fee  as part of the application.

Exemption Conditions : 

• Devices confirmed as obsolete or discontinued are exempt from registration requirements  but cannot be imported  or distributed .
• -Responsibilities of Establishments : 
• Maintain records of obsolete or discontinued devices.
• Provide technical assistance  related to these devices.

The document provides a clear process for managing these devices in compliance with regulations, ensuring safety and proper record-keeping in healthcare settings.

Region: Malaysia

Source: https://portal.mda.gov.my/index.php/announcement/1487-public-comment-draft-guidance-document-control-of-obsolete-and-discontinued-medical-device-in-healthcare-or-related-facilities