SFDA has recently published a Guidance for Product Classification Criteria; Click hereto read the official document.
Highlights from this Document
This guidance document pertains to a product or category of products that is under the responsibility of each sector within SFDA regulation.
This guidance presents the Saudi Food and Drug Authority’s (SFDA’s) current view on specific products or a category of products and whether it should be under the responsibility of Saudi Food and Drug Authority and particularly where the regulation may be on the borderline between two or more SFDA sectors. However, this guidance is not all-inclusive. Moreover, it does not provide any information about risk classes of medical devices.
In this guidance, SFDA states the services provided on this online system and the general process of obtaining a classification result from SFDA on your products
Ear Saline Preparations are considered now as Medical Devices (Point 6.18)
Nasal saline are considered as medical devices (Point 6.18)
Dermal fillers containing Hyaluronic acid are considered as medical devices
Eye drops intended for the alleviation dryness or discomfort caused by environmental factors are considered medical devices (See Point 6.17.2)
Nasal and ear saline preparations are considered medical devices
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