Andaman Medical Regulatory Affairs Update Malaysia

Malaysia: Draft Guidance Document: Placement of HIV Self-Test (HIVST) Kit in Malaysia Market

On February 19, 2024, the Medical Device Authority (MDA) of Malaysia released a draft guidance regarding the Placement of HIV Self-Test (HIVST) Kit in the Malaysian market. This guidance, identified as MDA/GD/0065, aims to provide direction for businesses interested in importing, exporting, or placing the Human Immunodeficiency Virus Self-Test kit (HIVST) in Malaysia.

This document, MDA/GD/0065, provides guidance for entities that intend to import, export or sell Human Immunodeficiency Virus Self-Test kits (HIVST) in the Malaysian market. The guidance covers the following areas:

  • HIVST detection method (type of test and sample type)
  • HIVST registration process (Scenario A applies to HIVST that have received premarket approval from recognized countries, while Scenario B applies to HIVST that have not received any premarket approval from recognized countries).
  • Performance criteria of the HIVST kit (sensitivity of the HIVST shall not be less than 99.0% for blood samples and not less than 92.0% for saliva samples, while specificity of the HIVST shall not be less than 99.0% for both blood and saliva samples).
  • Appoint CAB to conduct conformity assessment (by the way of verification or FULL conformity assessment) with Medical Device Technical Areas of IVD 0201 and IVD 0403 code.
  • Perform an evaluation test on the HIVST at a testing facility such as the Institute Medical Research (IMR) or any accredited local institute/laboratory with ISO 15189 for Registration Process via Scenario B only.

Further information on the draft guidance can be accessed here:

  1. Guidance document
  2. Feedback form

If you have any queries about this draft guidance, please contact us at or click the button below.

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