Saudi Arabia medical device regulations

MDS-REQ9 (running code MDS-REQ-002 V5, English version 2, version date 11 June 2024; resolved from the SFDA [regulations publication page](https://sfda.gov.sa/en/regulations/87126) to its direct official PDF): requirements for licensing medical device establishments — SFDA responsibilities and authorities, general requirements, and specific obligations for ten establishment categories (local manufacturers, authorized representatives, importers and distributors, warehouses, and six service-provider types incl. clinical-trial verification, testing laboratories, conformity assessment, radiation quality assurance, technical consultation, and medical maintenance), plus Annex 2 license periods and fees (5,000 SAR / 5 years for manufacturers). MDEL is required before device registration.

MDS-G010 Version 1.0 (3 January 2023): regulatory requirements for obtaining marketing authorization for AI/ML-based medical devices that diagnose, manage, or predict diseases by analyzing medical data — classification criteria, intended use, clinical evaluation, risk management, quality management systems, and change notification (major vs. minor changes with documentation), plus definitions and further reading. Title corrected to the official cover.

Operations Sector OPS-G-002 Version 8.0 (19 November 2023; posted December 2024): the cross-sector products classification guidance — objectives and general principles (statutory definitions; pharmacological, immunological, or metabolic means), the SFDA classification decision chart, sector definitions, the Product Classification System (PCS) online process with service fees and appeal/variation services, and sector chapters for food, drugs, cosmetic products, medical devices, tobacco (with feed and pesticides), and borderline products. The official file’s text layer is damaged (spaces extract as U+0679, section numbers as U+FFFD); the corpus normalizes both during extraction. Feed and pesticide subsection headings never render, so that content folds into the tobacco section.

MDS-REQ-005 Version 6.0 (19 July 2023): requirements on importation and shipment clearance of medical devices and supplies — ten importation purposes (circulation, used devices, local manufacturing, clinical studies, research and education, GHAD system, demonstration, national emergency, humanitarian, personal importation, free sale certificates), the required-documents matrix, and Annexes 1-10 (declarations and attestation forms, the free-sale application form, and definitions). Title corrected to the official cover: the previous metadata title described MDS-REQ1, not this document.

MDS-G008 Version 2.0 (13 December 2022), 80 pages: the medical device classification guidance — the A-D risk class system, medical device definition and implementation rules (intended purpose, combination devices and accessories, body parts, multiple-rule devices, continuous use, direct diagnosis), the same rule set for IVD medical devices, and rule-by-rule explanations with practical examples. Saudi Arabia uses GHTF/IMDRF-aligned classification; the class determines the registration pathway.

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.

MDS-G21 Version 4.0 (20 October 2020): shipment clearance requirements at the Kingdom’s ports of entry — no import without SFDA clearance, the used-device prohibition, remaining-shelf-life thresholds (40% under one year, 60% over one year), storage and data-logger obligations, sample withdrawal, the ten POEs, the per-shipment required documents (purchase invoice, bill of lading/air waybill, declaration of conformity, MDEL copy), and the clearance flowchart. Title corrected to the official cover.

MDS-G5 Version 5.0 (22 June 2020), 149 pages: the comprehensive guidance on medical device listing and marketing authorization (MDMA) — general requirements, submission and post-submission processes, the required-documents matrix (declaration of compliance with GHTF founding-member regulations, essential principles, technical documentation), a flowchart, and Annexes 1-13, including the risk classification rules (Annex 5), clinical evaluation and PMCF (Annex 6), fees and review times (Annex 9), MDMA certificate content (Annex 10), and bundling criteria (Annex 12).

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