MDA New Updates: Requirements for Labelling of Medical Devices in Malaysia

The Medical Device Authority’s (MDA) 2018 Guidance Document outlines Malaysia’s medical device labelling standards. In June 2022, the MDA released the Fifth Edition of MDA/GD/0026 on the Requirements for Labelling Medical Devices. This amendment will take effect on January 1, 2023, which specifies the labelling requirements that must be met by any businesses wanting to import and distribute medical devices into the Malaysian market. The MDA has informed the public that they will give transition period until 31 December 2022.

The following are the general labelling requirements published in the previous edition, Fourth Edition:

  1. Name, model, batch, serial number, date of manufacturing/date of expiry
  2. Malaysian medical device registration number
  3. Manufacturer Name, Address, Tel. No., Web address
  4. Technical details
  5. Description and intended use
  6. Instructions for use (note: low and moderate risk medical devices do not require IFUs)
  7. Undesirable side effect, limitations, warnings and precautions
  8. Post-market servicing requirements
  9. Decommissioning/disposal information

All products should be labeled in English. Products intended for home use should be labeled in both English and Bahasa Malaysia. The label cannot claim promotion or endorsement by the Ministry of Health or Medical Device Authority or any related organizational bodies.

NOW, with the coming into force of the Fifth Edition, the following amended labeling requirements will need to be complied:

  1. MDA now allows and encourages manufacturers to use a QR code for the registration number.
  2. For home use medical devices, Bahasa Malaysia translation shall be on the paper version of labelling pertaining to the device’s information.
  3. There’s a format provided where an Establishment shall include the MDA registration number on the labelling upon application approval.
  4. Compliance to the newly addition clause 4.8.2 and 4.8.3 in the Medical Device Guidance Document (MDA/GD/0026), Fifth Edition.

Click here if you want to know more about medical device registration in Malaysia.

Conclusion

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