Malaysia: Managing Obsolete and Discontinued Medical Devices in Healthcare Facilities

Malaysia’s Medical Device Authority (MDA) has issued a draft guidance document for the first edition of Control of Obsolete and Discontinued Medical Devices in Healthcare or Related Facilities. This article provides guidelines on managing medical devices that are obsolete or discontinued to ensure uninterrupted healthcare operations.

Obsolete Devices

• The manufacturer must officially declare a device as obsolete, meaning it is outdated and no longer manufactured due to design or technological advancements.

Discontinued Devices

• The manufacturer or authorized representative must declare a device as discontinued, meaning it is no longer being distributed in the market.

Confirmation Process and Exemptions

• The Medical Device Authority (MDA) must confirm the status of a device (obsolete or discontinued) before granting exemptions.
• These exemptions allow the continued use of such medical devices in healthcare facilities without requiring registration, ensuring that essential services remain uninterrupted.

Public Comment Submission

This draft is open for public comment and feedback. Establishments can submit their comments using the attached public comment form by November 26, 2024 to the following email addresses:

• anissuhaila@mda.gov.my
• nursyaza@mda.gov.my