MDA is constantly expanding and revising the local regulations, in light of the raging pandemic, to order to better equip the market with medical devices which have excellent safety and performance. In line with that, MDA has come up with a new guidance document for the various masks and respirators in the market.

In this guidance, MDA included the minimum requirements for face masks and respirators for the establishment to conform to register with MDA. Two types of face-mask and respirators considered as a medical device which are:

  1. 1. Procedure mask/respirator
  2. 2. Surgical mask/respirator – Fluid resistant

A procedure mask is intended to reduce the risk of spread of infections used by professional healthcare for performing patient procedures in the isolation room such as sterile cores and ER. A surgical mask intended to be used inside the operating room to protect from contamination. Also, a surgical mask is intended protect the wearer against splashes of potentially contaminated liquids.

Other than that, non-medical device face masks such as reusable cloth masks, fabric face masks, or single-use masks and non-medical respirators not intended for use in a clinical setting not regulated under Medical Device Act (Act 737). Both these devices are classified as personal protective equipment (PPE).

The establishment needs to submit the complete test report to MDA for the registration process. MDA included the performance characteristics that need to conduct by the establishment according to EN 14683:2019, ASTM F2100-9, YY 0469, and YY 0969. All the test shall pass the performance criteria. Table 1 below showed the minimum performance and labeling requirements that shall be complied with by the establishment.

Types of Medical Mask/Respirators

Minimum Performance

Minimum Labelling Requirements

Procedure mask/respirators

Shall comply with:

- All requirements in EN 14683:2019.

  • Or at least comply with requirements:
  • -Test Methods Type 1 or Type II in EN 14683:20, or
  • - ASTM F2190-19 ‘Level 1’, or
  • - YY/T 0969 with ≥95% BFE, or
  • - Any equivalent standard.

Shall comply with MDA Requirements for Labelling of Medical Device.

Addition description of the mask and BFE (%)

Surgical mask/ respirator – Fluid resistance

Shall comply with:

  • - All requirements in EN 14683:2019 ‘Types IIR’, or
  • - ASTM F2100-10 ‘Level 2 or Level 3’, or
  • - YY/T 0469 with ≥ 98% BFE or
  • - Any equivalent standard

Shall comply with MDA Requirements for Labelling of Medical Device

Figure 1 the picture showed the difference in physical characteristics between a face mask and respirator.

Figure 1: Type of mask   (L) and respirator (R)


Guidance Documents Medical Face Mask and Respirator