Common mistakes in registering Low-Risk Medical Devices 

Saudi DoC:

It must be printed on the official letterhead of the manufacturer and be signed and stamped by the manufacturer as well as by the Chamber of Commerce in the country of origin, in addition to writing full product details such as the risk classification, the classification rule followed, the product models, the trade name and the general name.

European Free Sale Certificate:

It must be submitted from one of the European Union countries. The manufacturer must be mentioned with all its details in the certificate in addition the name of the product to be registered.

Labelling:

Information and requirements of the manual must match with the identification label such as (the product’s trade name – country of origin – the name of the manufacturer and its address – the model – and others).

The Manufacturer details:

The manufacturer details must be mentioned completely in the first section and be exactly matched to all documents submitted in the application.

The organizational path (jurisdiction):

The organizational path (jurisdiction) must be chosen and documents submitted accordingly.

Fields to be filled in Arabic language:

All fields must be filled in in English, except for the fields designated for home use devices it must be in the Arabic language.

Resource: Saudi Food & Drug Authority | https://www.sfda.gov.sa/