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SFDA’s Guidance on Requirements for Medical Masks and Particulate Respirators

SFDA has recently published a Guidance on Medical Masks and Particulate Respirators -Recognized Standards; Click here to read the official document.

Published on: 26th October, 2020

Highlights from this Document

This guidance document clarifies the requirements for obtaining Medical Devices Marketing Authorization of Medical Masks, in order to place them on the market within KSA.

This guidance applies to: Manufacturers, Authorized Representatives, Importers and distributors.

Non Medical Masks that are labeled as “For Non-Medical Use” which are regulated by the Saudi Standards, Metrology and Quality Organization (SASO).

Medical masks and particulate respirators shall obtain Medical Devices
Marketing Authorization (MDMA), and shall comply with the
requirements specified in “Guidance on Requirements for Listing and
Medical Device Marketing Authorization (MDS – G5)”, including
“Essential Principles of Safety and Performance” specified in the
mentioned guidance.

Medical Face masks can be divided into three levels:

  • Level (A): BFE ≥ 95%
    To be used for general medical procedures where there is no risk of blood or body fluid splash.
  • Level (B): BFE ≥ 98% without or with low splash resistance.
    To be used in Emergency, change dressing room, dentistry, and other similar procedures
  • Level (C): BFE ≥ 98% with high splash resistance.
    To be used in surgical procedures or other procedures with similar requirements

Required tests for medical mask:

  • Bacterial filtration efficiency (BFE)
  • Breathability (Differential pressure)
  • Splash resistance/Penetration by Synthetic Blood
  • Microbial cleanliness (Bioburden)
  • Biocompatibility
  • Sub-Micron Particulate Filtration
  • Flammability test
  • Differential pressure following appropriate NIOSH standard test procedures (STPs)
  • Particulate filtration efficiency following appropriate NIOSH standard test procedure
  • Exhalation valve leakage following appropriate NIOSH standard test procedure (STP)

Biocompatibility

  • Splash resistance/Penetration by Synthetic Blood
  • Practical performance
  • Leakage
  • Flammability
  • Carbon dioxide content of the inhalation air
  • Strength of attachment of exhalation valve housing
  • Breathing Resistance
  • Clogging

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