Medical Device Regulation for Saudi SFDA
An overview of SFDA medical device requirements: classification, registration, quality systems and post-market obligations.
At a glance
- 2 days
Who it's for
- Medical device manufacturers and importers
- Regulatory affairs staff
- Authorised representatives
Learning objectives
- Classify medical devices correctly
- Prepare SFDA marketing authorisation
- Meet quality system requirements
- Fulfil post-market obligations
Detailed content
- Classification rules
- IVDs
- Borderline products
- MDMA file
- Technical documentation
- Labelling in Arabic
- ISO 13485
- Risk management
- Establishment licensing
- Vigilance reporting
- Field safety notices
- Recalls
Day-by-day agenda
A typical schedule. In-company versions are tailored to your processes, data and timing.
- Device classification
- Registration
- Quality system requirements
- Post-market duties
- Case study, action plans and course assessment
Practice, tools and assessment
Hands-on practice
- Mock regulatory inspection of a GMP area
- Deviation and CAPA case study with root cause
- Write a qualification/validation protocol outline
- Case studies from Egyptian and Gulf organizations
Tools and templates you keep
- Deviation, CAPA and change-control forms
- Validation master plan outline
- Course workbook and slide handouts
- Templates and checklists used in the exercises
How learning is assessed
- Pre- and post-course knowledge check
- Assessment of practical exercises by the trainer
- Action plan reviewed at the end of the course
Built on these standards and bodies of knowledge
- EU GMP / PIC/S Guide; WHO GMP
- ICH Q8–Q10, 21 CFR 210/211
- Egyptian Drug Authority (EDA) guidelines
Certificate
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
New in our 2026 portfolio — tell us your dates and we will confirm the trainer and schedule.
How it is delivered
- Public courses in Cairo, in-company programs and live online training
- Practical exercises, case studies and examples from your sector
- Can also run as Train & Stay in Sharm El Sheikh, Hurghada or Cairo
Frequently asked questions
How long is Medical Device Regulation for Saudi SFDA?
The program runs 2 days. In-company versions can be adapted to your needs.
Is the course taught in Arabic or English?
Sessions are usually delivered in Arabic with English technical terms and materials. Full English delivery is available for in-company groups.
Can you run it inside our company?
Yes. In-company programs use exercises built on your own processes. Tell us the group size and preferred timing and we will send a proposal.
Will I receive a certificate?
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
More programs in this field
- HACCP and Food Safety Risk Analysis
- ASQ CPGP – Certified Pharmaceutical GMP Professional (Exam Preparation)15 days
- GMP Auditor Training for Quality Systems2 days
- GMP for Medical Devices (ISO 13485)2 days
- GMP for Pharmaceutical Facilities, Equipment & Utilities3 days
- GMP in Pharmaceutical Laboratories2 days
- Good Laboratory & Good Manufacturing Practices (GLP + GMP) Workshop5 days
- Good Manufacturing Practices (GMP) for the Pharmaceutical Industry5 days
- Pharmaceutical Clean Rooms & HVAC: Design, Qualification and Monitoring4 days
Get dates, fees and the full outline.
Tell us whether you are joining as an individual or planning a program for your team.