With the wider spread of COVID-19, there is a raising alarm for ventilators shortage. Pursuant to the situation, Saudi Food and Drug Authority (SFDA) devised guidance for quick market entry of ventilators and its accessories, within KSA (Kingdom of Saudi Arabia). The guidance specifies the requirements and recognized standards to obtain the Medical Devices Marketing Authorization (MDMA) for ventilators, ventilator tubing connectors, and ventilator accessories.
SFDA/MDS (Medical Devices Sector) issued this guidance in reference to Article Three of “The Law of Saudi Food and Drug Authority” and the requirements specified in “Guidance on Requirements for Medical Device Marketing Authorization (MDS – G5)”. It is applicable to all the manufacturers, importers, authorized representatives, and distributors of ventilators and ventilator accessories.
As required by the SFDA Essential Principles or evidence of equivalent demonstration of compliance, manufacturers are expected to follow the state-of-the-art standards and guidance. To demonstrate the fulfillments of relevant Essential Principles, the following compliant standards can be used.
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Requirements |
Compliant Standards |
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Particular ventilators related standards |
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Ventilator tubing, connectors and ventilator accessories |
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Biological evaluation and biocompatibility |
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Batteries safety |
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Software |
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Usability |
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Risk management |
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Labeling |
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Are you looking to market ventilators in the jurisdiction of the SFDA? Staying on par with the guided Regulatory standards, manufacturers can surpass the incompliant procedures, approval delays and untimely market entry. For on-the-ground Regulatory assistance, consult a Regulatory expert. Stay safe. Stay informed. Stay compliant.
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