Translated with AI

In February 2026, the Medical Device Authority (MDA) published the 7th edition of the guidance document “Requirements for Labelling of Medical Devices”, updating the labelling requirements that have been in effect since 2022.

The document introduces a rigorous framework for the adoption of e-IFU (Electronic Instructions for Use) and tightens rules regarding transparency and information accuracy.

The Digital shift: e-Labelling

The most significant update concerns the expansion of electronic labelling.

  • Extension of e-IFU to “Home Use” devices: previously, e-IFUs were almost exclusively permitted for professional devices; now, their use is also allowed for home-use devices. This adoption depends on the potential risk identified by the manufacturer.
  • Risk Analysis: manufacturers must conduct, document, and maintain a specific risk analysis in their records. This analysis must address 10 critical factors, including user experience, the environment of use, access to digital resources, and medical emergencies.

New Accessibility Standards

To ensure that innovation does not limit product usability, the new Section 4.13 introduces accessibility standards (“Accessibility of e-IFU”):

  • Standard formats: use of readable files with adjustable fonts and contrast.
  • Operational continuity: an obligation to guarantee access to content even offline, along with emergency procedures in case of website downtime.
  • Direct access: mandatory integration of QR Codes, URLs, or barcodes on the device or packaging for immediate linking.

Language and content: consumer focus

The guide clarifies and reaffirms the rules for language use (Sec. 4.7):

  • Bahasa Malaysia (BM): mandatory for devices intended for home use; the translation must be present on the label itself.
  • English: remains the accepted standard for all other types of devices.

Essential label elements

  • Contact Data:
    • For Local Manufacturers and AR (Authorized Representatives): Name, address, and at least one contact method (email, phone, or website) are mandatory.
    • For foreign manufacturers: name, address, and website are mandatory.
  • Technical support: contact information must be explicitly provided to facilitate technical assistance.
  • Warning on Over-labelling: it is strictly forbidden to cover sensitive data – such as batch numbers, manufacturing dates, or expiration dates- with additional labels.

Specific requirements for IVDs

For In Vitro Diagnostic (IVD) Medical Devices, the 7th edition expands the set of required information:

  • Analytical performance: specific indications of sensitivity, specificity, and accuracy.
  • Metrological traceability: results and identification of reference materials and higher-order measurement procedures.

Compliance and deadlines

  • Malaysian Registration Number: all registered Medical Devices must display the Malaysian registration number on the label within 6 months of the document’s publication date (Deadline: July 31, 2026). This obligation applies to new batches placed on the market (manufactured or imported) after this deadline.
  • Display Methods: the use of a QR Code extracted from the registration certificate to display the number digitally is encouraged.
  • Prohibition of endorsement: the use of statements or logos suggesting any promotional approval by the MDA or the Ministry of Health (MOH) is prohibited.

>>> Is your product portfolio ready for Malaysia? Thema can support you in all regulatory compliance matters for the Malaysian market with strategic-regulatory consultancy services.

SOURCE:
PUBLICATION OF SEVENTH EDITION OF GUIDANCE DOCUMENT ON REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES