What the package contains: forms and records
Forms and records document what your establishment actually does.
Reviewed: October 2026
| 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.
The short answer: forms and records are where your establishment enters what it actually did: temperature readings, receiving and issuing, traceability, complaints, audits and destruction. They are the evidence asked for at inspection. You receive each form as its own Word file, with a combined booklet for printing and a filling guide.
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.
How many forms do you receive?
| Activity | Forms and records |
|---|---|
| Importer and distributor | 60 |
| Warehouse | 75, of which 17 are warehouse forms (F-83 to F-99) |
| Authorized representative | 74, of which 15 are authorized representative forms (F-100 to F-114) |
| Local manufacturer | 79, of which 21 are factory forms (F-60 to F-82; the two sterilization forms F-74 and F-76 are added for factories that supply sterile devices) |
The counts follow the establishment's activity and its answers.
Shared forms, by process
| Process | Forms |
|---|---|
| Document control | Document issue cycle and decisions record; document distribution and receipt list; request to issue, change or withdraw a document; list of external-origin documents |
| Work environment and storage | Cleanliness and storage-area condition checklist; fault report or maintenance request; temperature and humidity monitoring record |
| Competence and training | Job description card; competence matrix; training record; training plan; training effectiveness evaluation |
| Traceability and recall | Traceability record for incoming and outgoing; customer list and contact details; recall and traceability drill record |
| Management review | Meeting invitation; agenda; minutes and attendance; decisions and follow-up record |
| Complaints and reports | Feedback record; customer satisfaction survey; complaints record; complaint and investigation card; incident report form for the NCMDR |
| Internal audit | Audit programme; audit assignment notice and plan; checklist; audit report and follow-up; auditor qualification and impartiality declaration |
| Data analysis | Data analysis report; performance indicator dashboard |
| Calibration | Measuring equipment, calibration and verification register; calibration status label |
| Identification | Item identification card; item status cards |
| Receiving and issuing | Receiving inspection form; issue or delivery note; expiry and inventory follow-up record |
| Returns | Return note; returns record and disposition decision |
| Purchasing and suppliers | Purchase order; request for quotation; approved supplier list; supplier evaluation form; supplier nonconformity notice |
| Nonconformity and destruction | Nonconformity report; destruction record; nonconformity log |
| Corrective action | Corrective or preventive action form; corrective and preventive action log |
| Risk | Risk identification and assessment record |
| Records | Record retention schedule; records inventory and destruction request; record destruction execution minutes |
| Customer orders | Customer order record |
| Licence undertakings | Undertaking to apply the procedures submitted to SFDA; power-cut contingency plan and its test record |
Importers and distributors have two forms of their own:
- delay and unavailability register with the NCMDR notice;
- register of high-risk devices dispensed on prescription.
Why records?
- Archive of data, documents and operations: at least 5 years, easy to retrieve.
- Transport and storage documents: at least 3 years.
- Storage-condition monitoring records: at least one year.
- Before SFDA: documents and information go to SFDA within 10 days of its request, and inspectors review documents during visits.
- A procedure alone is not enough: having a procedure does not show it is applied; the dated, signed record is what shows it.
The filling guide
The forms come with a filling guide that explains each form; its examples are illustrations, not records. Start each record from the date you begin applying it, and do not copy the examples into it.
References
| Number | Official name | Link | Last updated |
|---|---|---|---|
| MDS-REQ-009 | Requirements for Licensing of Medical Devices Establishments | https://www.sfda.gov.sa/sites/default/files/2025-03/MDS-REQ%209_En_V2.pdf | 2025-01-15 |
| MDS-REQ-012 | Requirements on Transporting and Storage for Medical Devices | https://www.sfda.gov.sa/sites/default/files/2026-08/MDS-REQ12E_0.pdf | 2024-12-15 |
Browse the package contents and published prices. The Inspection Simulator is a separate product and is not available for purchase.