Malaysia: MDA Released Guidance Document MDA/GD/0065: Placement of HIV Self-Test (HIVST) Kit in the Malaysian Market

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”. 

This document aimed to provide guidance to guide the establishment on both pre-market, placement on the market and post-market requirements including requirements on registration of HIVST, licensing of establishments dealing with HIVST, product labelling, advertising and distribution and post-market surveillance and vigilance activities. 

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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