September 2023

In line with the issuance of Circular Letter No. 1 Year 2023 entitled “Permission for Placement in the Market of Human Immunodeficiency Virus (HIV) Disease Self-Test Kits,” the Medical Device Authority (MDA) of Malaysia has taken a crucial step by releasing the Guidance Document MDA/GD/0065 entitled “Placement of HIV Self-Test (HIVST) Kit in Malaysia Market”.

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

The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled ‘Importation of Medical Device for Re-Export’ for public review and feedback. The key takeaways of this draft guidance document are as follows: 1. Scope: Applies to all products that fall within the definition of medical device, as defined in MDA/GD/0001: Definition

The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled “Wearable Medical Device” for public review and feedback. The key takeaways of this draft guidance document are as follows: Scope: To determine the wearable products that fall within the definition of medical device as stipulated in Section 2 of Medical Device