Medical device manufacturers looking to sell items for home use in Saudi Arabia now will need to include barcodes on the product packaging.
For devices with a unique device identifier-compliant barcode, manufacturers should enter the static device identifier information only, according to a new FAQ document released by the Saudi Food & Drug Authority. If the device lacks a UDI-compliant code, the applicant should use the International Article Number barcode, if available. If neither of those is used, the applicant may use any other type of barcode.
Manufacturers of software-only devices, as well as products that either have a small container or are packaged in a material that does not lend itself to barcoding, may provide a justification for an exemption to the SFDA.
The requirements, which are already in effect, apply, at a minimum, to the unit of sale packaging.
Companies whose applications are under review should take steps to ensure their products are properly coded. If their first SFDA after-payment review took place June 7, 2015, or later, they must submit the barcode information through the device application.
Firms whose first review took place prior to that date may submit the information in the application, or through a new barcode module after their product is approved.
The SFDA intends to provide a barcode verification system through smartphone applications.
“By scanning a device barcode, information about the device as well as the manufacturer and authorized representative will display to the public to make sure that this device has been authorized by SFDA,” says Azzam Alothman, quality and risk director for the authority’s medical device sector. The tool will provide fast, easy access to that information, Alothman adds.
Alothman tells IDDM that companies making any type of medical device may submit barcode information, even for products not intended for home use.
The regulator intends to extend its track and trace requirements to other device categories, and this marks the beginning of the initial enforcement stage.
The FAQ document can be read at www.fdanews.com/07-06-15-saudibarcode.pdf.
— Elizabeth Hollis