Malaysia Introduces New e-IFU & Digital Labelling Guidance for Medical Devices

Malaysia’s Medical Device Authority (MDA) has published the updated guidance document “MDA/GD/0026 – Requirements for Labelling of Medical Devices (7th Edition)” on the MDA portal. The revision introduces formal provisions for electronic labelling, expanded requirements for electronic Instructions for Use (e-IFU), and new accessibility expectations, while reaffirming compliance with the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012.

The update reflects Malaysia’s gradual shift toward digital information delivery in medical device labelling. At the same time, the guidance introduces safeguards intended to ensure that electronic documentation does not compromise traceability, usability, or access for end users.

Malaysia Introduces Formal Definitions for Electronic Labelling

One of the most notable changes in the 7th Edition is the introduction of formal terminology for electronic labelling (e-labelling). While digital access to device information has become more common globally, previous versions of the guidance did not clearly define how electronic formats fit within Malaysia’s medical device regulatory framework.

The revised guidance now recognizes several digital mechanisms through which medical device labelling information may be accessed, including:

• URL links
• QR codes
• Unique Device Identification (UDI)–linked digital information
• Barcodes
• Radio-frequency identification (RFID)

Manufacturers remain responsible for ensuring that electronic delivery methods maintain the same level of clarity, reliability, and traceability expected from traditional printed labelling.

The guidance applies to all medical devices and in vitro diagnostic (IVD) devices marketed in Malaysia, except those exempted under the “Medical Device (Exemptions) Order 2024.” Promotional materials and product brochures remain outside the regulatory scope of device labelling.

New Requirements for Electronic Instructions for Use (e-IFU) in Malaysia

In addition to recognizing digital labelling formats, the updated guidance introduces strengthened regulatory expectations for implementing electronic Instructions for Use (e-IFU) for medical devices in Malaysia.

Manufacturers must conduct and document a formal risk analysis before adopting e-IFU. The risk evaluation should consider factors such as:

• Device type and intended users
• Clinical environment
• Access to digital tools
• Potential usability or safety risks

For home-use medical devices, eligibility for e-IFU depends on the outcome of this manufacturer risk assessment.

Document Control Requirements for Electronic IFU Systems

The guidance also emphasizes the importance of robust document control systems for electronic medical device documentation.

Manufacturers adopting e-IFU must establish procedures that ensure proper document governance and system integrity, including:

• Version control and revision management
• Preventing unauthorized modification or tampering
• Maintaining accurate and traceable documentation updates

These measures align electronic IFU management with broader medical device quality management system requirements.

Accessibility Requirements for Electronic Device Information

The updated MDA guidance also introduces accessibility provisions to ensure that digital medical device labelling remains accessible to users.

Manufacturers must ensure that electronic IFU platforms provide:

• Commonly accessible digital file formats
• Adjustable text size and improved legibility
• Direct access mechanisms such as QR codes or URLs
• Offline access where appropriate
• Clear display of document version numbers and revision dates

Users must also be able to request a paper copy of the Instructions for Use at no additional cost. This requirement ensures that essential device information remains accessible to individuals who cannot easily access electronic documentation.

In addition, manufacturers must maintain customer support channels to assist users experiencing difficulties accessing electronic information.

These provisions are particularly relevant for companies supplying consumer-facing or home-use medical devices in Malaysia.

Language Requirements for Medical Device Labelling

The updated guidance reiterates language requirements for medical device labelling in Malaysia, particularly for devices intended for consumer use.

Bahasa Malaysia is mandatory for home-use medical devices, while English remains acceptable for other device categories. Where translations are used, manufacturers must ensure that translated text does not obscure critical product identifiers, including:

• Lot number
• Serial number
• Manufacturing date
• Expiry date

This requirement ensures traceability information remains clearly visible regardless of language format.

Regulatory Controls on Medical Device Labelling

The guidance also reiterates several compliance requirements governing medical device labelling in Malaysia.

Key provisions include:

• Prohibition of statements implying endorsement by the MDA or the Ministry of Health
• Prohibition of using the MDA logo on medical device labelling
• Mandatory inclusion of manufacturer and Authorized Representative contact details
• Requirement to include the Malaysian registration number within six months after device registration

These requirements reinforce existing compliance obligations under Malaysia’s medical device regulatory framework.

Regulatory Impact for Foreign Medical Device Manufacturers

For overseas manufacturers and Authorized Representatives, the updated guidance introduces practical considerations for managing digital labelling and IFU systems for medical devices registered in Malaysia.

Companies should review their labelling strategies and documentation processes to ensure alignment with the revised guidance.

Key actions include:

• Reviewing device labelling to ensure compliance with the MDA labelling guidance (7th Edition)
• Evaluating whether devices qualify for electronic IFU and document the required risk assessment
• Updating internal SOPs governing electronic documentation and revision control
• Confirming compliance with accessibility requirements and Bahasa Malaysia obligations for home-use devices

Conducting an early regulatory gap assessment can help manufacturers reduce compliance risks during MDA inspections or post-market surveillance activities.

Final Thoughts

As regulators worldwide continue to evaluate digital labelling models, Malaysia’s approach reflects a familiar regulatory balance — enabling technological adoption while maintaining safeguards for usability, transparency, and patient safety.

For manufacturers, the practical implications lie primarily in governance. Electronic IFU systems, QR-based access points, and other digital labelling tools must be supported by clear risk justification, controlled document management, and demonstrable accessibility for end users.

Against this backdrop, international manufacturers supplying devices to the Malaysian market must ensure that their medical device labelling and e-IFU strategies comply with Malaysia’s latest MDA requirements.

To navigate Malaysia’s evolving medical device labelling regulations successfully, contact Cisema today. With a local office in Penang, Cisema supports companies navigating Malaysia’s medical device regulatory framework through regulatory intelligence, product registration support, and regional market access expertise in Malaysia and across APAC.

Further Information

• Explore Cisema’s services for medical device registration in Malaysia.
• Read our guide to medical device registration in Malaysia for foreign manufacturers, covering the latest timelines, fees & tips

References

Manufacturers can review the official announcement through the MDA publication notice for the updated labelling guidance.

Additional regulatory references include:

• Medical Device Regulations 2012
• Medical Device Act 2012 (Act 737)

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