SFDA: Requirements for Medical Masks and Particulate Respirators

Regulatory Background

The present SFDA guidance is intended to provide medical device manufacturers and other parties involved in operations with medical devices with additional clarifications regarding the applicable requirements and recognized standards to be considered when applying for a Medical Devices Marketing Authorization (MDMA) – permission necessary to be allowed to market medical devices in Saudi Arabia. The document is addressed to medical device manufacturers, their authorized representatives, and also the importers, and distributors. The scope of the guidance covers medical masks (including surgical masks) and particulate respirators. At the same time, the authority additionally emphasizes that the masks intended for non-medical purposes are actually falling outside the scope of the guidance since they are subject to the regulation by the Saudi Standards, Metrology and Quality Organisation (SASO), and not by the SFDA. 

The guidance on requirements for medical masks and particulate respirators is actually based on the following laws and regulations:

• 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, and
• Requirements specified in “Guidance on Requirements for Listing and Medical Device Marketing Authorization (MDS – G5).”

Requirements for Medical Masks and Particulate Respirators 

First of all, the SFDA guidance outlines the general requirements applicable to the medical devices covered by its scope. As it was already mentioned before, the manufacturers of medical masks and particulate respirators shall apply for the MDMA in order to be allowed to market their products in the KSA. The aforementioned devices should also comply with the requirements set forth in the guidance MDS – G5, as well as the Essential Principles of Safety and Performance, set forth therein. The medical device manufacturers are also allowed to refer to the SFDA recognized standards to demonstrate compliance with the Essential Principles mentioned hereabove, providing that any and all requirements prescribed by the appropriate standards are met. Such an approach allows us to simplify and accelerate the premarket review procedures to be carried out before the medical device would be allowed to be placed on the market.

Recognized Standards

The document also contains a list of the standards recognized by the SFDA and thus allowed to be used by the manufacturers to demonstrate compliance with the applicable requirements.
In particular, the list provided by the SFDA includes, inter alia, the following standards:

1. EN 14683:2019+AC: 2019 “Medical face masks Requirements and test methods.” 
2. ASTM F2100 – 19e1 “Standard specification for performance of materials used in medical face masks.” 
3. EN 249:2001+A1:2009 “Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing and marking.”
4. SFDA.MD/ISO standards 10993-1:2018, 10993-4:2018, and 10993-10:2018.
5. ISO 11737-1:2018 “Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products,” and others. 

According to the documents, the medical device manufacturers are also allowed to apply the relevant standard test procedures (STPs) of NIOSH. 

Medical Masks Labelling Requirements 

Besides the aforementioned points, the SFDA guidance also outlines the requirements related to the labeling of medical masks and particulate respirators. According to the document, such devices should comply with the labeling requirements set forth in the appropriate standard applied by the manufacturer to demonstrate conformity, and also in the guidance MDS – G5, which describes the general requirements the medical device should meet to be eligible for listing and marketing authorization.

Terms and Definitions 

In order to assist medical device manufacturers and other parties involved in operations with medical devices covered by the scope of the guidance with applying the provisions set forth therein, the SDFA also included a list of the definitions and abbreviations used within the document. This list includes, in particular, the following definitions: 

1. Manufacturer – refers to any individual or entity responsible for design and manufacture of a medical device, which intends to market such device under his name, irrespectively of the medical device is actually designed and/or manufactured by such individual or entity or by a third party acting on behalf of that individual or entity. 
2. Authorized Representative – any individual or entity based in Saudi Arabia, acting in accordance with the letter of authorization issued by the medical device manufacturer, providing that the scope of its activity covers the representation of the manufacturer in the relationships with the regulating authority. 
3. Importer – any individual or entity based in Saudi Arabia and intended to market foreign medical devices. 
4. Distributor – any individual or entity carrying out the activity related to the direct supply of medical devices to the customers (end users).
5. Medical Face Mask – a product designed to protect portions of the wearer`s face, including the mucous membrane area of the wearer`s nose and mouth, from contact with blood and other body fluids during medical procedures. According to the document, this category includes a wide range of products, such as surgical masks, procedure masks, isolation masks, and dental masks. 

Particulate Respirator – mask fitted to the user’s face, forming a seal that provides a physical barrier to fluids, particulate materials, and aerosols.

Additional Details and Requirements 

Apart from the aspects described hereinabove, the SFDA guidance on the requirements for medical masks and particular respirators also provides the classification rules to be applied for such devices and also outlines the tests to be performed for medical masks and particulate respirators separately. This information should be considered by the medical device manufacturer when determining the regulatory status of their products and their eligibility for listing and marketing authorization. 

According to the guidance, there are three levels (each based on the Bacterial filtration efficiency – BFE) to be applied for medical face masks, namely: 

• Level (A): BFE ≥ 95% – such devices could be used for general medical procedures, providing that there is no risk of blood or body fluid splash. 
• Level (B): BFE ≥ 98%, including both devices with low splash resistance or without much resistance at all – such devices could be used in dentistry, change dressing room, and also in Emergency and for similar procedures.
• Level (C): BFE ≥ 98%, the devices with high splash resistance – such devices could be used in surgical procedures. 

As it was already mentioned before, the present SFDA guidance also addresses the required tests to be carried out. In particular, the list of tests required for medical masks includes biocompatibility, BFE, breathability, flammability, microbial cleanliness, splash resistance, and sub-micron particulate filtration tests.  The list of tests required for a particulate respirator is slightly wider and includes special tests prescribed by the NIOSH standard test procedures (STPs).

Summarizing the information provided here above, the SFDA guidance on the requirements for medical masks and particulate respirators describes the general regulatory approach with regard to such products and also highlights the most important aspects to be taken into consideration by the medical device manufacturers in order to achieve and sustain compliance with the applicable requirements.

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Sources:

https://beta.sfda.gov.sa/sites/default/files/2020-10/MDS-G46e.pdf