Saudi Arabia · Certification
ISO 13485 certification in Saudi Arabia
Achieve ISO 13485 certification in Saudi Arabia with Sterling: 8,100+ client engagements in 60+ countries, 20+ years.
- Accredited certification
- Riyadh office team
- Effivity software included
- Academy training included
Who asks for ISO 13485 in Saudi Arabia
Clients include
ISO 13485 certification in Saudi Arabia at a glance
MDS requires ISO 13485 for the organisations it covers. Most Saudi buyers ask for it anyway.
Saudi device rules name ISO 13485 directly. The Saudi Food and Drug Authority's Requirements for Medical Devices Marketing Authorization (MDS-REQ 1) expect manufacturers to establish, document and maintain a quality management system according to ISO 13485:2016, and its Requirements for Licensing of Medical Device Establishments (MDS-REQ 9) ask local manufacturers, authorised representatives, importers and distributors, according to their category, for either a certificate of conformity to SFDA.MD/GSO ISO 13485:2017 from an accredited conformity assessment body or documented evidence or an SFDA inspection report. That makes the standard a licensing matter for importers and distributors as well as factories. Certificates come from conformity assessment bodies accepted under the SFDA requirement. Sterling's Riyadh office implements the quality management system, covering storage, distribution, traceability, complaint handling and post-market activities for distributors, design and production controls for manufacturers, and prepares the evidence for SFDA submissions and certification audits. The questions Saudi device companies ask are answered below.
Who needs ISO 13485 in Saudi Arabia, and what happens without it
For some organisations in Saudi Arabia it is a legal requirement. For most, the question comes from a buyer, a regulator or a partner that wants proof before it signs. These are the organisations that get asked.
- Medical device manufacturers seeking SFDA marketing authorisationMDS-REQ 1 requires a QMS according to ISO 13485:2016.
- Local manufacturers and authorised representativesMDS-REQ 9 links establishment licensing to SFDA.MD/GSO ISO 13485:2017 conformity.
- Medical device importers and distributorsDepending on category, a certificate of conformity or documented evidence/SFDA inspection is required.
Not sure which of these applies to you?Answer a short set of questions and your readiness report arrives by e-mail.
Take the ISO 13485 readiness checkISO 13485 requirements in Saudi Arabia
Strip away the vocabulary and ISO 13485 requires a company to prove six things about making medical devices that are safe and work as intended.
In Saudi Arabia these six sit alongside the local laws and regulations listed under drivers below; one system can evidence both. The detail is on the global hub: ISO 13485 explained →
How to get ISO 13485 certified in Saudi Arabia
One team from the Riyadh office carries the work from scoping to certificate. Clients across the Kingdom, from the Riyadh office; on-site where the work needs it and remote delivery for distributed teams.
- Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
- Gap assessment against ISO 13485 and the Saudi requirements that apply to youControls you already run for your regulators and customers are reused, not rebuilt.
- Your system built with your team in EffivityRisks, controls, evidence, incidents and reviews in one live system the auditor can see.
- Internal audit, management review and corrective actionsYour internal auditors trained by Sterling; the evidence proven before the certification body arrives.
- Certification body stage 1 and stage 2, then surveillanceAn accredited body audits and decides. Sterling supports the audits and the three-year cycle.
- End to end, from one team
- Effivity ISO & GRC software
- Preferential Sterling Academy access, with complimentary awareness training for your people
- Internal auditor training for your audit team, as applicable to your standard
- Vulnerability assessment on ISMS engagements
The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements.Sterling does not certify. Certification decisions stay with independent bodies.
How long does ISO 13485 certification take in Saudi Arabia?
There is no standard duration: it depends on your scope and on how much of the system already runs. In Saudi Arabia these are the factors that set the timeline.
- Establishment category under MDS-REQ 9
- Design and manufacturing versus import and distribution scope
- Storage, traceability and post-market processes in place
- Certification body scheduling around Ramadan, the Eid holidays and the Sunday–Thursday working week
Sterling agrees a dated plan with you on the discovery call, once the scope is known.
How much does ISO 13485 certification cost in Saudi Arabia?
The cost has two parts: the consulting work to build and prove the system, and the certification body’s audit fees, which are quoted separately. In Saudi Arabia these factors move both.
- Scope of activities (design, manufacture, import, distribution)
- Number of sites and warehouses
- Certification body audit fees quoted separately from consulting
- Validation of processes and software
Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.
ISO 13485 consultants and certification bodies in Saudi Arabia
Two different organisations are involved. A consultant helps you build the system and prove it works; an accredited certification body then audits or assesses it and decides. Keeping the two separate is what makes the result credible to buyers and regulators.
- Check that the body’s accreditation or approval covers ISO 13485 and your sector, and that its certificates can be verified online.
- Ask the consultant how the local requirements in Saudi Arabia are mapped into the same system, so nothing runs twice.
- Ask for client references in your sector; Sterling’s client letters are available on request.
- Agree who owns the evidence and the tool after the engagement; with Sterling the system stays yours, in Effivity.
Laws and regulations that drive ISO 13485 in Saudi Arabia (2)
| Instrument | How it treats the standard |
|---|---|
| MDS – REQ 1: Requirements for Medical Devices Marketing Authorization (SFDA) | Requires Manufacturers establish, document and maintain a QMS according to ISO 13485:2016; no explicit certificate requirement in this document. |
| Requirements for Licensing of Medical Device Establishments (MDS-REQ-009-V2.0, SFDA) | Requires Depending on category, a certificate of conformity to SFDA.MD/GSO ISO 13485:2017 from an accredited conformity assessment body, or documented evidence or an SFDA inspection report. |
Accreditation, audit language and remote audits in Saudi Arabia
For establishment licensing, the certificate must come from a conformity assessment body accepted under the SFDA requirement (MDS-REQ 9); otherwise use a certification body accredited for ISO 13485 by SAAC or another body within the international mutual recognition arrangements (Global ACI — Global Accreditation Cooperation Incorporated, formerly the IAF MLA). No body is named here unless verified. Edition and transition details: ISO 13485 hub →
Audit language
Arabic and English audits are both available in the market; agree the audit and document language with the certification body at application, and follow any Arabic-language requirement of a regulator or government buyer.
Remote and on-site
Remote audit elements are at the certification body's discretion under its accreditation rules; operational sites are normally visited on-site.
ISO 13485 in Saudi Arabia: questions clients ask
Do Saudi medical device importers and distributors need ISO 13485?
Possibly, depending on category. Under the SFDA's requirements for licensing medical device establishments (MDS-REQ 9), an establishment provides either a certificate of conformity to the Saudi standard SFDA.MD/GSO ISO 13485:2017 from an accredited conformity assessment body, or documented evidence or an SFDA inspection report. Which applies turns on your category; confirm it with the SFDA.
Does SFDA marketing authorisation require an ISO 13485 certificate?
Not explicitly. MDS-REQ 1 requires manufacturers to establish, document and maintain an effective quality management system according to ISO 13485:2016, but that document sets no explicit third-party certificate requirement. Check with the SFDA what evidence it will accept for your device and your authorisation route.
Which edition does the SFDA cite?
It cites two versions. MDS-REQ 1, on marketing authorisation, refers to ISO 13485:2016, while MDS-REQ 9, on establishment licensing, refers to the Saudi adoption SFDA.MD/GSO ISO 13485:2017. Check which document applies to your activity, and confirm the current edition with the SFDA before you plan the quality system.
Who can issue the certificate?
For establishment licensing, the certificate must come from a conformity assessment body accepted under the SFDA requirement in MDS-REQ 9. Otherwise, use a certification body accredited for ISO 13485 by SAAC or another body within the international mutual recognition arrangements. Confirm acceptance with the SFDA before you commission an audit.
More on ISO 13485 for Saudi organisations
Other standards Saudi businesses ask Sterling for
Organisations in Saudi Arabia often combine ISO 13485 with one of these, under one management system where the scopes allow.
Start with a free discovery call from the Riyadh office
A Sterling consultant goes through your entities, your regulators and your target date with you. No proposal until the scope is agreed.
Sources
- MDS – REQ 1: Requirements for Medical Devices Marketing Authorization (SFDA) — sfda.gov.sa (accessed 5 Oct 2026)
- Requirements for Licensing of Medical Device Establishments (MDS-REQ-009-V2.0, SFDA) — sfda.gov.sa (accessed 5 Oct 2026)
- Saudi Accreditation Center (SAAC) — ilac.org; iaf.nu (accessed 5 Oct 2026)
Talk to a consultant
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