On August 24, 2023, the Guidance Document MDA/GD/0065 related to the Placement of the HIV Self-Test (HIVST) Kit in the Malaysian Market was released.
This comprehensive document has been carefully crafted to guide establishments involved in HIV Self-Test (HIVST) kit operations. It covers various vital aspects, including pre-market preparations, placement on the Market, and post-market requirements.
Key areas addressed in this guidance encompass the registration of HIVST, licensing requirements for establishments dealing with HIVST, product labeling, advertising, distribution procedures, and the critical domain of post-market surveillance and vigilance activities.
For the full resource please visit HERE.
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