Malaysia: MDA Published Third Edition Guidance for Medical Face Mask and Respirator

ARQon
Jun 1, 2023
1 min read

Since the world got hit by the Covid 19 pandemic, face masks and respirators were not mandatory only for healthcare workers but the public is also required to wear face masks to prevent any infectious diseases. 2 types of face masks and respirators available in the market, medical face masks and respirators used for the clinical setting and non-medical face masks and respirators used for an industrial setting.

Face masks and respirators that were claimed by the manufacturers as medical devices should be defined as stated in Section 2 of Act 737 and required to be registered as Class A medical devices, called medical face masks and respirators, under the Medical Device Act (Act 737). Thus, Medical Device Authority (MDA) released the third edition of guidance for medical face masks and respirators.

The manufacturers of medical face masks and respirators shall submit test reports to the authority as part of the registration requirements for the medical devices. However, Class A medical devices do not need assessment from Conformity Assessment Body (CAB).

The manufacturer must be aware of the requirements required by the authority through Act 737 of Medical Device Regulations 2012 for manufacturing medical face masks and respirators.