This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.

This document is a written explanation to guide the establishment who deal with HIVST to comply to the requirements for pre-market, placement in the market and post-market including requirements on registration of HIVST, licensing of establishments dealing with HIVST, product labelling, sales, distribution and advertising and post-market surveillance and vigilance activities.

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-

  1. Medical Device Act 2012 (Act 737);
  2. Medical Device Regulations 2012;
  3. The Medical Device (Advertising) Regulations 2019;
  4. The Medical Device (Duties and Obligations of Establishments) Regulations 2019; and
  5. Circular letter No. 2/2023 Permission for Placement in the Market of Human Immunodeficiency Virus (HIV) Disease Self-Test Kits

To view the guidance document,  CLICK HERE

 

Updated: 31 January 2025

By: Corporate Communication Unit