In brief: Saudi classification guidance explicates submissions process and product changes

The Saudi Food and Drug Authority (SFDA) has published version 4.1 of the Saudi FDA Products Classification Guidance. New in this version is a section dedicated to detailing the use of the e-Product Classification System (PCS) for online submission of product classification applications. The PCS can also be used to access and appeal classification decisions when they become available. The guidance provides step-by-step instructions for registering with the system and submitting applications, along with a table of possible application statuses.

Another significant change to the guidance is the re-classification of several product types previously regulated as drugs. These consist of eye drops intended to alleviate dryness or discomfort caused by environmental factors, nasal and ear saline preparations, and hyaluronic acid fillers, all of which are now classified as medical devices.

Related Saudi Arabia medical device market resources from Emergo by UL:

• SFDA medical device registration and approval consulting
• Saudi Authorized Representative in-country representation
• Process chart: SFDA medical device registration requirements
• Whitepaper: Medical device registration in Saudi Arabia