By Stewart Eisenhart, Emergo Group
New rules issued by medical device market regulators in the Kingdom of Saudi Arabia require new barcodes for some types of devices registered for sale in the KSA.
For now, the Saudi Food and Drug Authority (SFDA) requires barcode data only for home-use/lay-person devices. New barcode information must be included in Medical Device Marketing Authorization (MDMA) applications registrants submit to the SFDA prior to commercialization in the country.
According to a list of frequently asked questions released by the SFDA, barcodes must be included on every individual device for sale in the KSA, and should be provided on one of two formats. For devices that already have barcodes compliant with Unique Device Identification (UDI), information for those devices’ Device Identifier numbers should be included in KSA registrants’ MDMA applications. For devices without UDI-compliant barcodes, registrants should enter EAN-13/UPC barcode data in their MDMA applications if that information is available. However, if neither UDI-compliant nor EAN-13/UPC barcodes are available for a device, then “any other type of barcode is acceptable,” states the SFDA FAQ document.
The new barcode is currently in effect; MDMA applicants whose first SFDA review after registration fee payment occurred on or before 7 June 2015 are exempt from the new requirement for the time being; applicants that had not paid fees as of 7 June 2015 must update their applications to comply.
Emergo consultants are monitoring the situation to see how SFDA regulators will enforce the new requirement, and whether any additional types of medical devices undergoing KSA registration will have to comply with the new barcode requirements.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
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