What the package contains
Reviewed: October 2026
The short answer: your package contains quality management system documents in three families: core documents, procedures, and forms and records. They are based on a mapping of the international ISO 13485:2016 clauses to requirements listed for your activity. Clause by clause equivalence with the Saudi adoption, SFDA.MD/GSO ISO 13485:2017, has not yet been verified. The package alone does not establish that equivalence; review it before approval.
| Activity | Core documents | Procedures | Forms and records | Total |
|---|---|---|---|---|
| Importer and distributor | 8 | 15 | 60 | 83 |
| Warehouse | 10 | 28 | 75 | 113 |
| Authorized representative | 10 | 28 | 74 | 112 |
| Local manufacturer | 10 | 23 | 79 | 112 |
The counts follow the establishment's activity and its answers.
You receive your documents as Word files in your establishment's name, and you review and approve them your own way before you submit them — and we guide you step by step to issuing your approved edition.
The three families
- Core documents: the head of your quality system — the quality manual, policy, organization chart and document list, and where to start.
- Procedures: how your establishment carries out each process, and the procedures of your activity.
- Forms and records: where you record what you actually did, your evidence at inspection.
References
| Number | Official name | Link | Last updated |
|---|---|---|---|
| SFDA.MD/GSO ISO 13485:2017 | Saudi standard SFDA.MD/GSO ISO 13485:2017 — Medical devices: quality management systems | — | Not stated |
Browse the package contents and published prices. The Inspection Simulator is a separate product and is not available for purchase.
Package prices by main activity
Final customer totals in SAR. No account is needed to browse.
- Local manufacturers: 4,490 SAR
- Authorized representatives: 3,490 SAR
- Importers and distributors: 2,490 SAR
- Warehouses: 3,490 SAR
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