Malaysia Introduces New Rules for Medical Device Labelling and e-IFU

The Medical Device Authority (MDA) has released the 7th Edition of the guidance document “Requirements for Labelling of Medical Devices” (MDA/GD/0026), introducing updated expectations for how medical devices must be labelled in Malaysia.

The updated guidance reflects the growing shift toward digital information delivery in healthcare, particularly through the introduction of electronic labelling (e-labelling) and electronic Instructions for Use (e-IFU).

The guidance supports compliance with the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012, which regulate medical devices marketed in Malaysia.

A Step Toward Digital Labelling

One of the most notable updates in the new guidance is the formal recognition of electronic labelling.

Manufacturers may now provide certain device information electronically, such as through:

This approach reflects global regulatory trends where digital labelling helps reduce paper usage while allowing manufacturers to provide more frequently updated information to users.

Risk Assessment Required Before Using e-Labelling

Although electronic labelling is now allowed, the MDA requires manufacturers to conduct a documented risk analysis before implementing it.

Manufacturers must demonstrate that:

This ensures that digital labelling does not compromise patient safety.

Paper Instructions Still Required for Home-Use Devices

Despite the move toward digital labelling, the guidance clearly states that home-use medical devices must still include paper-based instructions and labelling.

This ensures accessibility for patients and caregivers who may not always have reliable digital access.

Labels Cannot Suggest Regulatory Endorsement

Another important clarification is the prohibition of statements or symbols that may imply regulatory endorsement.

Manufacturers must not place references such as:

on product labels if they could mislead users into believing the device is officially endorsed.

What This Means for Medical Device Companies

With this updated guidance, companies planning to supply devices in Malaysia should review their labelling strategies and documentation.

Manufacturers may benefit from the flexibility of electronic labelling, but they must ensure compliance with the safety, accessibility, and documentation requirements outlined by the MDA.

The updated guidance highlights Malaysia’s continued efforts to modernize its medical device regulatory framework while maintaining strong patient safety standards.

Source: Official announcement from the Medical Device Authority (MDA), Malaysia.