December 9, 2020
Medical Face Masks and Particulate Respirators - Decode SFDA’s Requirements and Recognized Standards

As it is well known, Medical masks to be launched in the Kingdom of Saudi Arabia (KSA), must obtain Medical Devices Marketing Authorization (MDMA). In reference to the same, the Saudi Food and Drug Authority(SFDA) has recently released a guidance to specify and clarify the requirements and recognized standards to streamline products’ market-entry.

The guidance is applicable to manufacturers, authorized representatives, importers, and distributors of medical masks (including surgical masks) and particulate respirators. Non-medical masks that are labeled as “For Non-Medical Use” do not fall under the purview of this guidance. The SFDA has issued the guidance document in reference to:

  • Article Three of “The Law of Saudi Food and Drug Authority” issued by the Royal Decree No.(M/6) issued on 25/1/1428 H
  • Requirements specified in “Guidance on Requirements for Listing and Medical Device Marketing Authorization (MDS – G5)”

Requirements: Medical masks and particulate respirators shall obtain MDMA and they are required to 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”.

Recognized Standards: Relevant recognized standards for medical masks and particulate respirators include:

  • EN 14683:2019+AC: 2019 “Medical face masks requirements and test methods”
  • ASTM F2100 – 19e1 “Standard specification for performance of materials used in medical face masks”
  • GSO ISO 22609:2009 “Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood”
  • ASTM F2101 – 14 “Standard test method for evaluating the Bacterial Filtration Efficiency (BFE) of medical face mask materials, using a biological aerosol of Staphylococcus aureus
  • ASTM F2299 ASTM F2299/F2299M – 03(2017) “Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres”
  • EN 149:2001+A1:2009 “Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing and marking”
  • NFPA 702 “Standard for Classification of the Flammability of Wearing Apparel”
  • ASTM F1862/F1862M – 17 “Standard test method for resistance of medical face masks to penetration by synthetic blood”
  • SFDA.MD/ISO 10993-1:2018 “Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process”
  • SFDA.MD/ISO 10993-5:2018 “Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity”
  • SFDA.MD/ISO 10993-10:2018 “Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization”
  • ISO 11737-1:2018 “Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products”
  • EN 1041:2008+A1:2013 “Information supplied by the manufacturer of medical devices”
  • SFDA.MD/ ISO 15223-1 “Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General requirements”
  • Relevant standard test procedures (STPs) of NIOSH

Labeling: Medical masks and particulate respirators labeling should comply with, labeling requirements specified in the applied standard(s) and the “Guidance on Requirements for Listing and Medical Device Marketing Authorization (MDS – G5)”.

As many of us know, given the stringent Regulatory scenarios of the KSA market, launching medical face masks and particulate respirators in this particular market involves a complex procedure. To enter jurisdiction of the SFDA, manufacturers must meet aforementioned requirements and recognized standards. To surpass the market-entry Regulatory bottlenecks, consult an expert. Stay informed. Stay compliant.