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The costs and time required to process Class C medical device registration in Saudi Arabia depend on several factors such as documentation readiness, whether the product already has international approvals (e.g., CE, FDA), and the involvement of third-party services. Below is a detailed breakdown of all associated costs and timelines based on the current SFDA regulatory framework:
🕒 Time Required for Class C Medical Device Registration
| Process Step | Estimated Time | Notes |
|---|---|---|
| 1. Appoint Authorized Representative (AR) | 1–2 weeks | Mandatory for foreign manufacturers |
| 2. Establishment License (EL) application | 2–4 weeks | For both AR and manufacturer |
| 3. Technical documentation preparation | 4–6 weeks (or more) | Depends on availability of CE/FDA docs and internal readiness |
| 4. MDMA (Marketing Authorization) submission & SFDA review | 3–6 months | Includes document review and any back-and-forth responses |
| 5. MDMA approval and certificate issuance | Immediate after approval | Approval letter + certificate download |
| 🟢 Total Estimated Time | 5–8 months | End-to-end duration for most applicants |
⚠️ Note: If your device lacks prior regulatory approvals (CE/FDA), expect the SFDA review to take closer to 6 months.
💰 Cost Breakdown for Class C Medical Device Registration
| Cost Item | Estimated Cost (SAR) | Estimated Cost (USD) | Notes |
|---|---|---|---|
| ✅ Establishment License (EL) – Manufacturer | 5,000–7,000 SAR | $1,300–$1,870 USD | Required for legal manufacturer |
| ✅ Establishment License (EL) – AR | 5,000–7,000 SAR | $1,300–$1,870 USD | AR must hold an active license |
| ✅ MDMA Registration Fee (SFDA) | 8,000–15,000 SAR | $2,130–$4,000 USD | Varies based on device type and complexity |
| ✅ Translation Fees (IFU + labeling) | 2,000–3,000 SAR | $530–$800 USD | English to Arabic translations |
| ✅ AR Service Fee (optional) | 5,000–10,000 SAR | $1,300–$2,700 USD | If outsourcing registration to local rep |
| ✅ Consulting/Technical File Support (optional) | 5,000–10,000 SAR | $1,300–$2,700 USD | For manufacturers needing document preparation |
| ✅ Certificate of Free Sale (FSC) | Varies by origin country | Typically $100–$300 USD | Must be issued by competent authority |
| ✅ ISO 13485 Certification (if needed) | Varies | Typically $3,000–$10,000 USD | Only if manufacturer lacks valid certification |
💡 Typical All-In Cost Range
| Registration Scenario | Total Estimated Cost |
|---|---|
| 🔹 Low Cost (in-house, CE-certified device, no consultant) | 20,000–25,000 SAR ($5,300–6,700 USD) |
| 🔹 Full Support (AR + consultant + translations) | 30,000–40,000 SAR ($8,000–10,700 USD) |
| 🔹 No ISO/CE/FDA, complex device | 45,000+ SAR ($12,000+ USD) |
📌 Additional Notes
🔸 Validity Period
MDMA Certificate is valid for 3 years
Renewal required before expiration (usually faster than initial registration)
🔸 Fast-Track Option?
No formal fast-track for Class C, but CE or FDA clearance may allow for abridged review pathway, reducing review time.
✅ Summary: Costs & Timeline Overview
| Aspect | Value |
|---|---|
| ⏱ Total Time | 5–8 months |
| 💵 Total Cost Range | SAR 20,000–40,000 (USD ~$5,300–$10,700) |
| 📄 Document Translations | Arabic required for IFU, labeling |
| 🔍 Regulatory Pathways | Full or abridged, depending on prior approvals |
| 📜 Certification Validity | 3 years (MDMA Certificate) |
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
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