🇸🇦Saudi Arabia Medical Device Regulations

Saudi FDA Products Classification Guidance

Updated 2024 classification guidance for determining product classification based on presentation, composition, use, and design.

Requirements for Medical Device Marketing Authorization

Version 6.0 requirements document for medical device marketing authorization applications. Covers classification, documentation, and submission procedures.

Requirements for Licensing of Medical Devices Establishments

Requirements for licensing medical device establishments including importers and distributors. MDEL is required before device registration.

Guidance on Artificial Intelligence (AI) Medical Devices

Guidance on regulatory requirements for AI-enabled medical devices and machine learning algorithms in healthcare applications.

Medical Device Classification Guidance

Classification guidance for medical devices. Saudi Arabia uses GHTF/IMDRF-aligned classification (Class A, B, C, D). Classification determines registration pathway.

Medical Devices and Supplies Law

Primary law governing medical devices in Saudi Arabia. Royal Decree No. M/54 dated 6/7/1442 H establishes the legal framework for medical device regulation.

Guidance on Requirements for Medical Device Registration

Comprehensive guidance on documentation requirements for medical device registration applications including technical file requirements.

Guidance on Requirements for Importing Medical Devices

Guidance on requirements for importing medical devices into Saudi Arabia, including documentation and customs clearance procedures.

National Center for Medical Devices Reporting

NCMDR records, analyzes, and manages medical device recalls and adverse events. Objective is to reduce incidents and prevent recurrence of adverse events.