Medical device labelling is an essential element in ensuring the safety, performance, and proper use of medical devices. Clear and accurate labelling allows healthcare professionals, patients, and users to correctly identify a device, understand its intended purpose, and be aware of any warnings or precautions associated with its use. In Malaysia, labelling requirements are regulated under the Medical Device Act 2012 (Act 737), and manufacturers must ensure that all devices placed on the market are labelled in accordance with regulatory expectations.

The Medical Device Authority (MDA) has recently released the 7th Edition of the Guidance Document on Requirements for Labelling of Medical Devices (MDA/GD/0026), published in January 2026. This updated guidance provides recommendations to manufacturers and authorised representatives on how labelling information should be presented to ensure compliance with Malaysian regulatory requirements.

Key Updates in the 7th Edition

One of the key updates introduced in this revision is the inclusion of provisions for electronic Instructions for Use (e-IFU), along with clearer direction on labelling integrity and the use of internationally recognized symbols. The updated guidance highlights several important changes, including:

1. The introduction of provisions for electronic Instructions for Use (e-IFU), allowing manufacturers to provide device instructions through digital platforms such as websites, QR codes, or other electronic access points.
2. e-IFU may generally be used for devices intended for professional users, while its use for home-use medical devices requires an appropriate risk assessment.
3. Manufacturers implementing e-IFU must ensure that electronic instructions remain accessible, reliable, and consistent with the approved printed instructions, while still allowing users to request a paper version of the IFU when needed.
4. The guidance highlights the importance of providing assistance channels such as helplines, chatbots, or support portals for users who may experience difficulties accessing electronic instructions.
5. Additional labels, including those used to add Authorized Representative (AR) or importer details after importation, are permitted provided they do not obscure critical information such as batch or serial numbers, manufacturing dates, or expiry dates.
6. Any additional labelling must remain legible and durable throughout the device’s shelf life.
7. The guidance encourages the use of internationally recognized symbols in medical device labelling to improve clarity and support global harmonization, with manufacturers commonly referring to ISO 15223-1 when selecting symbols.
8. Where the meaning of a symbol may not be immediately clear, particularly for home-use devices, manufacturers are recommended to provide explanations to ensure correct interpretation by users.

Why this matters for manufacturers

As regulatory expectations continue to evolve, manufacturers and distributors should review their labelling practices to ensure alignment with the latest MDA guidance. Proper implementation of labelling requirements, the correct use of internationally recognized symbols, and the compliant adoption of electronic IFU systems are essential steps toward maintaining regulatory compliance and ensuring patient safety.

Navigating MDA labelling requirements? TECOLAB helps manufacturers ensure their medical device labelling remains compliant and market-ready in Malaysia.

Contact us today to start building your path to regulatory success.