There are several types of masks available in the Malaysian market that provide varying levels of protection against various health hazards. Face masks and respirators are regulated as medical devices if the manufacturer makes claims or describes the mask or respirator as a medical device, as specified in Section 2 of Act 737. The World Health Organisation (WHO) classified medical face masks into two types: procedure masks and surgical masks. Both are employed in clinical and health-care settings. This document will outline the criteria for both face masks and respirators.
The Medical Device Authority (MDA) has announced the release of the Third edition Guidance Document “Guidance on Medical Face Mask and Respirator”, which is available since May 19th, 2023.
The revised guideline revises Annex A of the WHO Recommendations Table on Mask or Respirator Use in Health Care Settings based on transmission scenario, target demographic, setting, activity, and type. Minor changes can be seen in COVID-19 Transmission scenario, Who, Setting, Activity and What type of mask column in the new edition.
Requirement for Medical Face Mask and Respirator