Medical Device Authority (MDA) has published a guidance document "Application For Confirmation Status Of Orphaned Medical Device’ for public comment.

This guidance document specifically outlines the eligibility criteria, application procedures, the responsibilities and obligations of healthcare facilities when managing these orphaned medical devices.

We would like to invite the industry and stakeholders to provide feedback on this draft guidance document. The public comment period for this draft guidance document is from 16-31st October 2025. Please submit your feedback using the attached public comment form to [email protected] before 31st October 2025.

This guidance document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following:

a) Medical Device Act 2012 (Act 737);

b) Medical Device Regulations 2012; and

c) Medical Device (Exemption) Order 2024.

To download guidance document, please download Attachment 1. To download feedback form, please download Attachment 2.

 

 

 

Prepared by: Policy and Strategic Planning Division (DASAR)

Uploaded by: Corporate Communication Division

Published Date: 16 / October / 2025