Malaysia MDA Launches Public Consultation on Medical Device Labelling

On 16 October 2025, the Medical Device Authority (MDA) released the Draft 7th Edition of Guidance Document MDA/GD/0026 – Requirements for Labelling of Medical Devices for public consultation, open until 31 October 2025.

This latest draft marks a significant milestone in Malaysia’s transition toward digital healthcare regulation. It reflects the growing role of electronic labelling in improving access to medical device information and expands the use of electronic instructions for use (e-IFU) beyond professional environments to include certain home-use devices.

Replacing the 6th Edition issued in November 2022, the new draft aligns Malaysia’s framework more closely with the IMDRF GRRP WG/N52 (2024) – Principles of Labelling for Medical Devices and IVDs. The update strengthens consistency with global best practices and supports the country’s broader regulatory digitalisation goals.

Key Proposed Revisions in the 7th Edition

The Draft 7th Edition introduces several important revisions that together form a more modern and flexible labelling system.

The following key areas illustrate how these revisions reshape the current framework.

Updated Scope and Legislative References

The guidance now references the Medical Device (Exemptions) Order 2024, replacing the 2016 version. It also clarifies that the requirements apply to all medical devices and IVDs except those specifically exempted, ensuring better alignment between current legislation and labelling obligations.

New Definition of Electronic Labelling (e-Labelling)

To improve clarity and regulatory consistency, the draft introduces a formal definition of electronic labelling in accordance with IMDRF 2024 principles. Recognised e-labelling media include URLs, QR codes, UDI, barcodes, and RFID systems. These channels are expected to enhance traceability, accessibility, and information integrity across device types.

Expanded Eligibility for e-IFU

One of the most notable updates is the broadened eligibility for e-IFUs – electronic instructions for use. While previously limited to professional-use devices, the 7th Edition permits certain home-use devices to use e-IFUs, subject to a manufacturer’s risk assessment.

Manufacturers must document and maintain a comprehensive risk analysis addressing user competency, backup access, cybersecurity protection, and emergency contingencies to ensure safe adoption of digital formats.

Enhanced Accessibility Requirements

A new Section 4.13, “Accessibility of E-Labelling,” introduces practical standards to make digital information easier to access and navigate. It specifies:

• Use of common digital formats (PDF/HTML) with adjustable fonts and contrast.
• Direct access mechanisms (QR code, URL, barcode) and offline availability.
• Version control and revision history for regulatory verification.
• Customer support channels (e.g. helpline or chatbot) for user assistance.
• Cybersecurity measures to prevent tampering or unauthorised modifications.

These provisions aim to ensure that e-labelling is not only compliant but also inclusive and user-friendly.

Simplified Paper Requirements

To balance innovation with accessibility, the draft relaxes requirements for printed labelling. Paper versions are now recommended (“should”) rather than mandatory (“shall”) for home-use devices. This change supports a smoother transition toward digital documentation while maintaining flexibility for users who still rely on printed information.

Consolidation of Previous Sections

To improve clarity and remove overlap, Sections 4.12.2 (Bahasa Malaysia translation for home-use devices) and 4.12.3 (instructions for professional-use devices) have been deleted. Their content is now consolidated under the updated e-labelling framework, simplifying navigation and interpretation.

What These Changes Mean for Stakeholders

Together, these revisions signal Malaysia’s shift from paper-based documentation toward a digital-first approach for medical device labelling and information management.

Manufacturers and Authorised Representatives (ARs) should start preparing by:

• Integrating digital labelling technologies such as QR codes, UDI linkages, and secure IFU hosting.
• Conducting and maintaining risk assessments that demonstrate safe e-labelling practices.
• Updating labelling templates and internal SOPs to reflect new accessibility and language requirements.

With the consultation open until 31 October 2025, stakeholders have an important opportunity to provide feedback to the MDA. Early participation will help ensure that the final version of the guidance remains practical, proportionate, and aligned with industry capabilities.

Summary and Outlook

This draft marks a major step toward Malaysia’s adoption of a modern, digital-first regulatory framework in line with international practice.

Once implemented, it is expected to improve user access to critical device information and reduce paper dependency, particularly for connected and home-care medical devices.

For companies navigating these changes, Cisema’s local team in Penang holds a valid MDA Establishment License as a local Authorised Representative. The team can register Class A–D medical devices, act as your Malaysian licence holder, and provide expert support with:

• Label compliance reviews and gap assessments
• Medical device registration and authorised representation with the MDA

Contact our team today to ensure your labelling systems are ready for compliance once the 7th Edition takes effect.

Further Information

• Explore Cisema’s Malaysia MDA Registration Services
• Read our Guide to Medical Device Registration in Malaysia

References

Medical Device Authority (MDA) – Draft 7th Edition of Guidance Document MDA/GD/0026: Requirements for Labelling of Medical Devices (2025)

• Announcement
• Guidance Document
• Feedback Form

International Medical Device Regulators Forum (IMDRF) – Good Regulatory Review Practices Working Group (GRRP WG/N52, 2024): Principles of Labelling for Medical Devices and In Vitro Diagnostic (IVD) Medical Devices

• Full Document (PDF)

Medical Device Authority (MDA) – 6th Edition of Guidance Document MDA/GD/0026: Requirements for Labelling of Medical Devices (November 2022)

• Guidance Document (PDF)

Medical Device Authority (MDA) – Medical Device (Exemptions) Order 2024

• Order Document (PDF)