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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.
Requirements | Compliant Standards |
Particular ventilators related standards | - ISO 10651-3:1997 - Lung ventilators for medical use
- GSO ISO 10651-4:2015 - Lung ventilators — Operator-powered and gas-powered emergency resuscitators
- SFDA.MD/ISO 17510:2017 - Medical devices — Sleep apnoea breathing therapy, masks and application accessories
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Ventilator tubing, connectors and ventilator accessories | - ISO 18250-1:2020 - Medical devices — Connectors for reservoir delivery systems for healthcare applications
- SFDA.MD/ISO 5356-2:2015 - Anesthetic and respiratory equipment — Conical connectors
- SFDA.MD/ISO 5361:2018 - Anesthetic and respiratory equipment — Tracheal tubes and connectors
- SFDA.MD/ISO 5366:2018 - Anesthetic and respiratory equipment — Tracheostomy tubes and connectors
- SFDA.MD/ISO 5367:2015 - Anesthetic and respiratory equipment — Breathing sets and connectors
|
Biological evaluation and biocompatibility | - SFDA.MD/ISO 10993-1:2018 - Biological evaluation of medical devices – Evaluation and testing within a risk management process
- SFDA.MD/ISO 18562-1:2017 - Biocompatibility evaluation of breathing gas pathways in healthcare applications
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| Batteries safety | - SASO-IEC-60086-4:2007 - Primary batteries - Safety of lithium batteries
- SASO-IEC-62281:2018 - Safety of primary and secondary lithium cells and batteries during transport
- SASO-IEC-62133-1:2017 - Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications. Nickel systems & Lithium systems
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| Software | - SFDA.MD/IEC 62304+AMD 1:2017 - Medical device software - Software life cycle processes
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| Usability | - SFDA.MD/IEC 62366-1:2018 - Medical devices - Application of usability engineering to medical devices
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| Risk management | - SFDA.MD/ISO 14971:2017 - Medical devices — Application of risk management to medical devices
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| Labeling | - SFDA.MD/ISO 15223-1:2017 - Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — General requirements
- EN 1041:2008+A1:2013 - Information supplied by the
- manufacturer of medical devices
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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.
