SFDA’s Products Classification Guidance

Medical Regulations Gate - Importation Requirements of Medical Devices - Radioactive Materials - Particle Accelerators - Marketing Authorization Applications - Medical Masks and Particulate Respirators - Quality Management System - Products Classification Guidance - mdma registration - compliance timeframe for medical devices - Guidance on artificial intelligence - Medical ultraviolet radiation

SFDA has recently published a Guidance for Product Classification Criteria; Click here to 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


For any questions, please drop us a message and we will contact you shortly