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Medicinal Gases Registration

This article describes the procedures and the requirements for submitting an SFDA registration application for medicinal gases products in Saudi Arabia. What are Medicinal gases?

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SFDA Labelling Requirements

SFDA has strict labelling and packaging requirements that companies have to comply with during the SFDA product registration process. Once this application is approved, the

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SFDA Stability Study Requirements

Stability studies are one of the important quality parameters of pharmaceutical products. It sets the drug shelf life, determines proper storage conditions, and therefore the

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SFDA Classification

In Saudi Arabia, the SFDA classification of products will not necessarily be the same as the product class in its country of origin. Therefore, there

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sfda product registration

SFDA Registration & Regulations

Learn about SFDA registration in Saudi Arabia covering different types of product applications, files, requirements, fees, and timelines. Also the Saudi FDA regulations for market entry.

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SFDA Medical Device Registration

Learn about SFDA medical device registration and related regulations in Saudi Arabia. The classification and approval process for devices, supplies and IVDs in MDMA (high risk) and MDNR (low risk). We also cover the new TFA requirements.

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SFDA Drug Registration Requirements

Description of the SFDA drug registration requirements in Saudi Arabia. The regulations & guidelines for new, biological, biosimilar, and generic drug applications. Including Module 1 and the eCTD.

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