Medical Devices Law & Implementing Regulation
The Medical Devices Law
The Medical Devices and Supplies Regulation — commonly referred to as the Medical Devices Law — is the primary legislation governing medical devices in the Kingdom of Saudi Arabia. It was issued by the Council of Ministers as Resolution No. 337 and came into effect in 2021, replacing the earlier Medical Device Interim Regulation.
Key provisions of the Medical Devices Law
- Definition of medical devices and IVDs (Article 1)
- Establishment of the MDMA requirement — all devices must be authorised before market entry
- Powers of the SFDA to regulate, inspect, and enforce
- Obligations of manufacturers, ARs, importers, and distributors
- Penalties for non-compliance
The Implementing Regulation (2021)
The Implementing Regulation of the Medical Devices Law provides detailed rules for applying the Medical Devices Law. It covers:
- Classification requirements
- Technical file content requirements
- QMS requirements
- Post-market surveillance and vigilance obligations
- MDEL requirements
- Clinical evaluation standards
The Implementing Regulation is the operational document — most practical compliance requirements derive from it and the MDS-REQ guidance series.
The Medical Device Interim Regulation (historical)
Before the current Medical Devices Law, the SFDA operated under the Medical Device Interim Regulation. The current law largely carries forward the Interim Regulation's requirements, with important modernisation aligned to EU MDR and the cancellation of the GHTF registration route.
How to access SFDA legislation
The Medical Devices Law and Implementing Regulation are published in Arabic on the official Saudi government legislation portal and summarised in English in the SFDA's guidance documents. The MDS-REQ 1 document provides the most practical English-language summary of registration requirements.