The World Health Organization (WHO) classifies medical face masks into two categories:

  1. Procedural masks, and
  2. Surgical masks

Both masks are used in clinical and healthcare settings. In line with that, Medical Device Authority (MDA) has published a new guidance document explaining that face masks and respirators that are intended for use for non-medical purposes or setting as those used in the construction or other industrial applications, to be considered as non-medical devices.

These medical face masks and respirator registration applications must be submitted in accordance with the regulations.  Below are the requirements for masks and respirators should comply with;

  1. EN14683: Medical face masks: Requirements and test methods
  2. ASTM F2100-19: Standard specification for performance of materials used in medical face masks
  3. YY 0469: Surgical mask
  4. YY/T 0969: Single-use medical face mask

The establishment of these standards is to ensure that all medical face masks and respirators sold in the Malaysian market meet high standards of safety and performance. Also, it can ensure effectiveness in preventing the transmission of contagious diseases.




Guidance Documents Medical Face Mask and Respirator (MDA/GD/0033)