malaysia mda releases public comment draft medical device guidance document on requirements for labelling medical devices

Malaysia MDA Releases Public Comment Draft Medical Device Guidance Document on Requirements For Labelling Medical Devices

Malaysia’s Medical Device Authority (MDA) has released draft guidance on 12 April 2022, for labelling registered medical devices. The draft guidelines are open for stakeholder comments until 28 April 2022.

This fifth edition introduces the following additions or changes:

  • Location of Labelling
  • General contents of labelling
  • Instructions for use (IFU)
  • Use of specific statements

This amendment of the fifth edition of MDA/GD/0026 provides  clear guidance for the use of Bahasa Malaysia. It shall be required for home use medical devices, where the Bahasa Malaysia translation shall be on the paper version of labelling pertaining to the device’s information.

This amendment also emphasizes the requirements of the contact details of the local manufacturer and AR by including their email, phone number, and website to obtain technical assistance.

Apart from that, this amendment provides an example of a format where the Establishment shall include the MDA registration number on the labelling upon application approval.

This amendment or fifth edition of MDA/GD/0026 will benefit the Establishment in terms of providing a clear explanation and guidance for each type of requirement to avoid confusion and meet the requirements of labelling as stipulated by the MDA. Additionally, this amendment makes general contents of labelling and instruction of use more feasible with regards to contra-indications, warnings, and precautions, and summary of safety and clinical performance information relevant to the user or patient.

Click here for the draft guidance on Medical Device labelling,

Sign up for our regulatory roundup delivered once a month to your inbox

Scroll to Top

Contact Us