MALAYSIA: MDA Regulatory Updates – Requirement of Labelling Guidance Document ＆ HSA Verification Approvals – February/March 2026

2026-04-01

Regulatory Background

The Medical Device Authority (MDA) has published the 7th edition of the guidance document on requirements for labelling of medical devices, MDA/GD/0005.

 

E-Labelling and e-IFU Requirements

This updated guidance document introduces a new implementation of e-labelling for home-use devices. The revisions include an update to the e-IFU section and new addition of accessibility of e-IFU as shown in the table below.

e-IFU

1.  Brief description of e-IFU

  • The implementation of electronic Instructions for Use (e-IFU) shall ensure that device users have continuous access to up-to-date information, equivalent in content and accuracy to that provided in paper form. The manufacturer shall maintain appropriate risk controls and documentation to ensure accessibility, security, and version consistency.
     

2.  Specific point of risk analysis for implementation of e-IFU

  • Knowledge and experience of the intended user
  • Characteristics of the environment of device that will be used
  • Access of the user to the electronic resources needed at the time of use
  • Performance of safeguard for the electronic data and content protected from tampering
  • Safety and back-up mechanisms
  • Foreseeable medical emergency situations
  • Impact caused by the temporary unavailability of the specific website or internet, and the safety measure of it
  • Assessment of the website's compatibility displaying the instructions
  • Management of different versions of the IFU
     

3.  Paper IFU and e-IFU revision

The corresponding paper IFU shall be revised accordingly within a defined timeframe to maintain version alignment and ensure that both formats contain consistent information.
Accessibility of e-IFU

1.  E-IFU shall be made available in commonly accessible digital formats with legible font, text size, etc.

2.  Provide a direct access mechanism such as QR code, URL, or barcode on the packaging or device to enable retrieval of the e-IFU

3.  Manufacture shall ensure the e-IFU can be downloaded or viewed offline.

4.  Each e-IFU shall clearly display its version number, date of issue, or revision history

5.  Manufacturers shall provide a customer support channel (e.g., helpline, chatbot, or website portal)

6.  4 E-IFU systems shall be designed with appropriate measures to prevent unauthorized modification, always ensuring data integrity and regulatory compliance.

 

Implementation Considerations

These updates aim to ensure that essential device information remains accessible to users while maintaining user safety, device performance, and regulatory compliance. The use of e-labelling approach is permitted provided that the manufacturer conducts an appropriate risk assessment demonstrating that safety and usability requirements are met.

 

Recognition of HSA Conformity Assessment

In addition, following to the latest regulatory update, the MDA has approved the use of conformity assessments conducted by the Health Sciences Authority (HSA) Singapore, through a verification process. This approval allows medical device manufacturers and suppliers who have undergone HSA conformity assessment to have their devices recognized under the Malaysian regulatory framework. Thereby facilitating smoother market entry while maintaining compliance with local standards.

 

With the introduction of e-labelling requirements and the recognition of HSA conformity assessments, medical device companies should review their current labelling practices and assess opportunities to leverage existing approvals for the Malaysian market.

Qualtech supports manufacturers in evaluating labelling compliance, implementing e-IFU strategies, and navigating streamlined registration pathways in Malaysia.

Contact us to ensure your products remain compliant and ready for efficient market access.

 

References

  1. Approval Issued by Health Science Authority (HSA) Permitted by MDA for Conformity Assessments by Way of Verification Process
  2. Publication of Seventh Edition of Guidance Document on Requirements for Labelling of Medical Devices
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TAG : malaysia mda , medical device labelling , e-ifu requirements , e-labelling malaysia , mda guidance 7th edition , medical device regulation malaysia , hsa conformity assessment , device labelling compliance

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