• 2023-07-21 02:46:26

The Medical Device Authority (MDA) published the Third Edition Guidance Document, "On Guidance on Medical Face Mask and Respirator", on May 19, 2023. This document is intended to give clarity on medical face masks and respirators regulated by the Medical Device Act (Act 737). This document applies to establishments, healthcare facilities, and the general public who deal with medical face masks and respirators.

• 2021-08-26 12:02:05

In light of the latest COVID-19 situation in Malaysia, MDA has published a guidance document on medical face masks and respirators. The MDA/GD/0033 explains the minimum requirements for labeling as well as the performance characteristics of face masks and respirators that need to fulfill.

• 2021-02-22 01:43:21

Masks and respirators, in various denominations. have become essential things in the new norm of life. There are many types of masks and respirators available in the Malaysian market. Thus, Malaysia Device Authority (MDA) published a new guidance document as a reference for stakeholders. This guidance explains of the type of face masks and respirators that are regulated under the Medical Device Regulations 2012 and the pre-requisites they need to fulfil.

• 2020-03-16 06:31:12

In a latest announcement, MDA has announced that unregistered face masks shall henceforth be placed in the market via a Special Access route.