The Ministry of Health (MoH) of Malaysia has initiated various efforts to combat HIV/AIDS infection in the country ever since the first detected case in 1986. One of which is by introducing an HIV self-testing (HIVST) as a pivotal method for Test and Treat HIV/AIDS. This initiative aims to encourage a larger segment of key populations and their partners to undergo screening and receive necessary treatment, which is in line with the global target to end AIDS by 2030. Since the HIVST will be handled by the public, the Medical Device Authority of Malaysia (MDA) released Circular Letter No. 1 Year 2023 entitled “Permission for Placement in the Market of Human Immunodeficiency Virus (HIV) Disease Self-Test Kits”, to ensure and regulate the safety and performance of HIVST when they are placed in the Malaysian market.
This circular letter covers the following criteria for the placement of HIVST in the Malaysian market:
- The HIVST that doesn’t have product approval from recognized countries, it shall undergo a full conformity assessment and performance evaluation in selected recognized laboratories;
- Sensitivity and specificity requirements;
- Provision on performance of HIVST shall be using the method of detecting antibodies & antigens;
- Distribution activities that are allowed; and
- Provision on HIVST selling and supply to the public.
This circular letter will be effective from the date the Polisi dan Prosedur Ujian Saringan HIV Kendiri by the Disease Control Division of the MoH is published.
For detailed insights into the policy regarding the placement of HIV Self-Test (HIVST) kits in the market, please click here.
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