Malaysia Updates Medical Device Labelling Guidance to Support Digital Labelling

Malaysia has taken another step toward modernising its medical device regulatory framework with the release of the 7th Edition of the Guidance Document on Requirements for Labelling of Medical Devices. The update was issued by the Medical Device Authority (MDA), introducing revisions that expand the use of digital labelling and improve accessibility of device information for users.

The updated guidance, known as MDA/GD/0026, provides manufacturers with clearer direction on labelling requirements for medical devices placed on the Malaysian market and reflects the regulator’s broader effort to align with international regulatory practices.

Moving Toward Digital Labelling

One of the most significant developments in the updated guidance is the increasing recognition of electronic labelling (e-labelling) as part of medical device information delivery.

The updated framework introduces a clearer definition of electronic labelling and recognises various digital formats through which information may be provided to users, including:

• QR codes

• URLs or web-based platforms

• Barcodes and other digital identifiers

  
  

These mechanisms aim to improve accessibility to device information while supporting better traceability and information management.

Expanded Use of Electronic Instructions for Use

Another important revision relates to electronic Instructions for Use (e-IFU). Historically, e-IFUs were primarily permitted for devices intended for professional healthcare settings.

Under the updated guidance, the eligibility for electronic instructions has been broadened to potentially include certain home-use medical devices, provided that manufacturers conduct an appropriate risk assessment to ensure users can access the information safely and effectively.

This change reflects a growing global trend toward digital health information while maintaining safeguards to protect patients and users.

Improving Accessibility and Usability

In addition to expanding digital labelling, the updated guidance introduces new expectations regarding the accessibility of electronic information.

Manufacturers are expected to ensure that digital labelling:

• Is available in widely accessible formats such as PDF or HTML

• Includes mechanisms such as QR codes or direct web access

• Maintains version control and revision history

• Provides support channels for users seeking assistance

These measures aim to ensure that electronic labelling remains user-friendly, reliable, and compliant with regulatory oversight.

Alignment With Malaysia’s Regulatory Framework

The updated labelling guidance continues to operate under Malaysia’s broader regulatory structure, including the Medical Device Act 2012 (Act 737) and its associated regulations.

The guidance applies to medical devices placed on the Malaysian market and provides detailed expectations regarding labelling content, language requirements, and the information necessary for safe device use.

For example, labelling must generally include key product identification details and safety information, while Bahasa Malaysia may be required for certain home-use devices to ensure accessibility for local users.

Implications for Manufacturers

For medical device manufacturers and authorised representatives operating in Malaysia, the updated guidance highlights several important considerations:

• Ensuring labelling compliance with the updated guidance document

• Assessing eligibility for electronic labelling and e-IFU implementation

• Implementing risk assessments for digital information delivery

• Ensuring accessibility and traceability of device information

Companies planning to introduce digital labelling solutions must also ensure that their systems maintain regulatory compliance while protecting data integrity and user accessibility.

ARQon Perspective

The introduction of expanded digital labelling provisions reflects a broader global shift toward digital regulatory systems and improved access to device information. By enabling electronic labelling while maintaining safeguards for patient safety, Malaysia’s regulator is aligning with international regulatory trends and supporting the evolving needs of modern healthcare systems.

For manufacturers, the update underscores the importance of staying informed about evolving labelling requirements and integrating digital strategies into regulatory compliance frameworks.

At ARQon, we continue to monitor regulatory developments across global markets to help organisations navigate changing compliance environments and bring safe, innovative medical technologies to patients worldwide.