SASO Urges Smart Orthotics Recertification by June 30, 2026

Saudi Standards, Metrology and Quality Organization (SASO) issued an urgent notification on May 2, 2026, mandating full safety and EMC retesting of all marketed Smart Orthotics — including intelligent knee orthoses and gait-feedback ankle-foot orthoses — against the newly published IEC 60601-2-77:2026 standard. Affected manufacturers, importers, and distributors serving the Saudi market must complete testing and submit reports from SASO-recognized laboratories by June 30, 2026. Non-compliant products will be barred from customs clearance starting July 1, 2026. This accelerated timeline — cut by 50% versus typical transition periods — signals tightening regulatory scrutiny in the Middle East medical device market, particularly for connected, electromechanical orthotic devices.

Event Overview

On May 2, 2026, SASO released Emergency Notification Ref: SASO/MD/NOT/2026/088. It requires all Smart Orthotics currently placed on the Saudi market to undergo full retesting per IEC 60601-2-77:2026 — covering essential safety and electromagnetic compatibility (EMC) requirements — and submit valid test reports from SASO-recognized laboratories no later than June 30, 2026. Products lacking updated certification will be prohibited from customs clearance effective July 1, 2026.

Industries Affected

Direct Exporters and Importers of Medical Devices to Saudi Arabia

These entities hold legal responsibility for product conformity under SASO’s Medical Devices Regulation. The shortened deadline directly impacts their ability to maintain market access; failure to meet the June 30 deadline results in immediate suspension of import eligibility, affecting inventory planning, sales contracts, and revenue recognition for Q3 2026.

Manufacturers of Smart Orthotics (OEM/ODM)

Manufacturers must initiate retesting immediately, as IEC 60601-2-77:2026 introduces updated requirements for wireless communication interfaces, real-time motion feedback systems, and battery-powered operation — potentially necessitating design or firmware revisions. Lab capacity constraints and report turnaround times pose tangible bottlenecks, especially for products requiring iterative testing.

Distributors and Authorized Representatives in KSA

Under SASO’s regulatory framework, local representatives bear compliance oversight duties. They are responsible for verifying submission completeness, maintaining documentation archives, and coordinating with SASO during audits. The tight window increases administrative risk and may trigger contractual liabilities if upstream suppliers delay submissions.

Key Actions for Stakeholders

Verify current certification scope and expiration date against SASO’s official database

Confirm whether existing SASO Type Approval Certificates explicitly reference IEC 60601-2-77:2015 or earlier editions — only those referencing outdated versions are subject to mandatory retesting. Cross-check certificate numbers and product models listed in Notification SASO/MD/NOT/2026/088.

Prioritize lab engagement with SASO-recognized testing facilities before May 20, 2026

Given reported lead times of 4–6 weeks for full IEC 60601-2-77:2026 testing (including pre-scan, emissions, immunity, and functional safety verification), early scheduling is critical. Confirm lab accreditation scope explicitly covers clause 203 (wireless functions) and Annex BB (gait feedback performance validation).

Review technical documentation for alignment with IEC 60601-2-77:2026 Annexes AA and BB

Focus specifically on risk management files (ISO 14971:2019), software validation records (IEC 62304:2006/Amd1:2015), and usability engineering documentation (IEC 62366-1:2015). Discrepancies here often cause report rejection or request for additional evidence.

Prepare internal cross-functional alignment between regulatory affairs, R&D, and supply chain teams

Coordinate timelines for sample dispatch, firmware version freeze, and labeling updates (e.g., revised compliance statements per Clause 7.9.2). Document all decisions related to test strategy — e.g., whether to test representative configurations or full model variants — to support future SASO inquiries.

Editorial Perspective / Industry Observation

Observably, this notification reflects a strategic shift toward proactive, time-bound enforcement rather than passive surveillance. Analysis shows SASO is aligning its medical device oversight more closely with EU MDR timelines and IEC adoption cadence — not merely mirroring standards but enforcing them with compressed transitions. From an industry perspective, this is less a one-off compliance event and more a signal of institutionalized acceleration: future standard updates (e.g., IEC 60601-1-12, IEC 82304-1) are likely to follow similarly abbreviated windows. Current stakeholders should treat this as a stress test of their regulatory responsiveness infrastructure — not just a checklist item.

Conclusion

This SASO notification underscores that regulatory agility is now a core operational requirement for medical device market access in the Gulf Cooperation Council (GCC) region. Its significance lies not only in the June 30 deadline itself, but in what it reveals about evolving enforcement priorities: tighter integration of international standards, reduced tolerance for legacy certifications, and heightened accountability across the distribution chain. It is better understood as an early indicator of systemic regulatory maturation — not an isolated administrative action.

Information Source

Primary source: SASO Emergency Notification Ref: SASO/MD/NOT/2026/088, issued May 2, 2026. No supplementary guidance or FAQs have been published as of May 5, 2026; stakeholders are advised to monitor SASO’s official portal (www.saso.gov.sa) for updates. The status of pending appeals or transitional allowances remains unconfirmed and is subject to ongoing observation.