SFDA Guidance: e-IFU Requirements for Medical Devices

Recently, the SFDA (Saudi Food and Drug Authority) has issued a guidance to clarify the e-IFU (electronic Information for Use) requirements for medical devices in Saudi Arabia. This guidance is issued in reference to the Essential Principles specified in, “Guidance on Requirements for Medical Device Listing and Marketing Authorization (MDS-G5).” It is applicable for medical devices (including IVD medical devices) supplied to the KSA (Kingdom of Saudi Arabia) market, with IFU in electronic form and is intended for professional users. Medical devices and IVDs intended for layperson use and near-patient testing are excluded. As per the guidance, the users may be provided with the following IFU requirements in electronic format.

The e-IFU Requirements

Indication that IFU is supplied in electronic form

• The information provided with the device shall clearly indicate that, the IFU of the device is supplied in electronic form instead of paper form. The URL (Uniform Resource Locator) indicating the e-IFU web address should be provided to the users with clear navigation, where relevant
• The IFU display shall not impede the safe use of the medical devices fitted with a built-in system, visually displaying the IFU (in particular, the life-monitoring or life-supporting functions)

Risk assessment: Medical device manufacturers willing to provide IFU in electronic form shall undertake a documented risk assessment, covering the following elements:

• Knowledge and experience of the intended users, in particular, regarding the use of the device, user needs and the hardware and software needed to display the IFU in electronic form
• Environmental characteristics of the device
• User’s access to reasonably foreseeable electronic resources, needed at the time of use
• Performance of safeguards, to ensure the protection of electronic data and content from tampering
• Safety and back-up mechanisms in the event of a hardware or software fault, particularly, if the e-IFU is integrated within the device
• A provision for IFU in paper form, during foreseeable medical emergency situations
• The impact caused by the temporary unavailability of a specific website or the internet in general, or their access in the healthcare facility, as well as, the safety measures to overcome such situations
• Evaluation of the time period, while providing IFU in paper form, as per the user’s request

e-IFU shall clearly state information about the target Regulatory jurisdiction and the date of release should be version controlled. For online IFU, where appropriate, the obsolete versions of the IFU shall remain accessible to the public. Also, the risk assessment shall be updated in view of the experience gained in the post-marketing phase.

Information in the e-IFU

• The e-IFU information shall include all the items specified in essential principles of, “Guidance on Requirements for Medical Device Listing and Marketing Authorization (MDS-G5)”
• Except implantable devices, for devices with a defined expiry date, the IFU shall be available for the users in electronic form for at least 2 years, after the end of the expiry date for the last produced device
• For devices (including implantable devices) without a defined expiry date, the IFU shall be available for the users in electronic form for a period of 15 years, after the last device has been manufactured

Website: Any website containing e-IFU for a device shall comply with the following requirements:

• The IFU shall be provided in a commonly used format that can be read with freely available software and in such a way that, the server downtime and display errors are reduced as far as possible
• The IFU shall be protected against hardware and software intrusion
• All the e- IFU previous versions and their date of publication shall be available on the website
• The IFU should be readily accessible, without a need to create an online account or password
• The IFU approved for Saudi market should be readily identified as such

The e-IFU leads to better customer understanding, enhanced device safety and improved patient outcomes. To reap the complete benefits of e-IFU and avoid Regulatory pitfalls, medical device manufacturers must adhere to the addressed SFDA requirements. Consider approaching a local Regulatory labeling expert, to ensure device compliance. Stay informed. Stay compliant.