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 Guidance Document also serves as guidance for establishments who wish to import, export or place Human Immunodeficiency Virus Self-Test kit (HIVST) in the Malaysia market.

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)       The Medical Device (Advertising) Regulations 2019;

d)      The Medical Device (Duties and Obligations of Establishments) 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 view the guidance document, CLICK HERE


update: 28 August 2023


  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 

Today 8070 Yesterday 7082 Week 15152 Month 36782 Jumlah Pengunjung: 119869846

  • Kemaskini Terakhir: 04 Disember 2023.
Copyright © 2023 Medical Device Authority
Ministry of Health Malaysia
Best view with Firefox 64 and above, minimum resolution 1366x768