Medical Device Authority (MDA) has published a guidance document ‘PLACEMENT OF HIV SELF-TEST (HIVST) KIT IN MALAYSIA MARKET” for public comment.

This document is written 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.

We would like to invite the industry and stakeholders to provide feedback on this draft guidance document. The public comment period for this draft guidance document is from 19 February to 1 Mac 2024. Please submit your feedback using the attached public comment form to anissuhaila@mda.gov.my before 1 Mac 2024.

This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following:

a) Medical Device Act 2012 (Act 737);

b) Medical Device Regulations 2012;

c) Medical Device (Duties and Obligations of Establishments) Regulations 2019;

d) Medical Device (Advertising) Regulations 2019; and

e) Circular Letter of the Medical Device Authority No.1 Year 2023 Permission for Placement in the Market of Human Immunodeficiency Virus (HIV) Disease Self-Test Kits.

To download guidance document, please download Attachment 1. To download feedback form, please download Attachment 2.