The Medical Device Authority (MDA) has released the draft Seventh Edition of the Guidance Document titled “Requirements for Labelling of Medical Devices” for public consultation. The draft introduces key amendments to the existing labelling framework, including the proposed implementation of electronic labelling (e-labelling) for home-use medical devices, aligning Malaysia’s regulatory approach with international best practices.
Scope
Summary of the draft guidance document issued by the Medical Device Authority (MDA), Malaysia, outlining updated labelling provisions and opportunities for stakeholder feedback.
Key Highlights
Purpose of the Update
- To update and clarify existing medical device labelling requirements
- To introduce e-labelling for home-use medical devices
- To align Malaysia’s labelling standards with global regulatory practices
Public Comment Period
- From 16 October to 31 October 2025
- Feedback must be submitted using the Public Comment Form (attached below)
Submission Instructions
- Submit completed forms to: guidancedocument@mda.gov.my
- Submission deadline: 31 October 2025
Applicable Laws and Regulations
This guidance document should be read in conjunction with:
- Medical Device Act 2012 (Act 737)
- Medical Device Regulations 2012
Attachment
See attached the draft of the Guidance Document – Requirements for Labelling of Medical Devices. [PDF]
Effective Date
To be announced upon final issuance of the guidance document.
Implications to Clients
Stakeholders are encouraged to review the proposed updates and provide constructive feedback during the consultation period. The inclusion of e-labelling may impact documentation, packaging, and user information practices for home-use medical devices.
All input received will assist the MDA in finalising the guidance document and ensuring alignment with international regulatory expectations.
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