Medical Device Authority (MDA) has published a guidance document "Requirements for Labelling of Medical Devices” for public comment.

This draft guidance serves to update and clarify the requirements for medical device labelling, particularly the inclusion of e-labelling requirements for home use medical devices. The proposed changes aim to align Malaysia’s regulatory framework with international practices while ensuring that users of home use medical devices continue to have access to accurate and readily available information in electronic formats.

We would like to invite the industry and stakeholders to provide feedback on this draft guidance document. The public comment period for this draft guidance document is from 16 to 31 October 2025.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

b) Medical Device Regulations 2012.

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: 15 / October / 2025