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Registering Class D medical devices in Saudi Arabia involves both time and financial investment due to the high-risk nature of these products. The Saudi Food and Drug Authority (SFDA) requires comprehensive documentation, clinical evidence, and sometimes even product testing or site audits. Below is a detailed overview of costs and timelines involved:
💰 Costs for Class D Medical Device Registration in Saudi Arabia
The total cost for registering a Class D medical device in Saudi Arabia includes regulatory fees, service provider fees, testing, translation, and compliance costs. The main components are:
🔹 1. SFDA Application Fees
These are official government fees for SFDA review and issuance of the Medical Device Marketing Authorization (MDMA):
| Item | Estimated Cost (SAR) | USD Equivalent (approx.) |
|---|---|---|
| Device Registration Fee (Class D) | SAR 25,000 – SAR 40,000 | USD 6,700 – USD 10,700 |
| Establishment License (per year) | SAR 10,000 – SAR 15,000 | USD 2,700 – USD 4,000 |
| Product Testing (if required) | SAR 5,000 – SAR 20,000+ | USD 1,300 – USD 5,300+ |
⚠️ Note: Fees may vary based on the device type (implantable, sterile, software-based), complexity, or SFDA revisions.
🔹 2. Consultant/Service Provider Fees (if applicable)
If using a regulatory consultant or Saudi Local Authorized Representative (LAR), these may include:
Dossier preparation: USD 2,000 – USD 6,000+
Local Authorized Representative annual fee: USD 3,000 – USD 10,000+
Clinical evaluation support: USD 3,000 – USD 10,000+
Translation services (Arabic): USD 500 – USD 2,000, depending on volume
🔹 3. Other Possible Costs
QMS (ISO 13485) audit (if requested by SFDA): variable, can be USD 5,000+
Testing reports (e.g., biocompatibility, sterilization): depends on lab and test scope
Labeling redesign for Arabic/English compliance
⏳ Timeline for Class D Medical Device Registration
Due to the complex and high-risk nature of Class D devices, the registration process is longer than for lower-risk devices. The timeline can be broken down into the following phases:
| Stage | Estimated Duration |
|---|---|
| LAR Appointment & Establishment Licensing | 2 – 4 weeks |
| Technical File & Clinical Documentation | 1 – 3 months (if not pre-prepared) |
| SFDA Administrative Review | 2 – 4 weeks |
| SFDA Technical & Clinical Review | 3 – 6 months (depending on device) |
| SFDA QMS Review / Audit (if triggered) | 1 – 2 months |
| Final MDMA Approval | 1 – 2 weeks |
🔸 Total Estimated Time: 6 to 12 months, assuming no major deficiencies or rejections during the review.
🧩 Factors Affecting Cost and Time
| Factor | Impact |
|---|---|
| Completeness of documentation | Missing/incomplete files lead to delays |
| Novelty of device technology | New tech requires deeper clinical review |
| Local Authorized Representative | Experienced LARs help speed up review |
| Prior approvals (e.g., CE/FDA) | Well-recognized approvals may reduce review burden |
| SFDA workload | High submission volumes can delay review |
📌 Summary Table
| Aspect | Details |
|---|---|
| SFDA Fee | SAR 25,000–40,000 (~USD 6,700–10,700) |
| Total Cost (est.) | USD 12,000 – 30,000+ (depending on services) |
| Timeframe | 6 to 12 months |
| Renewal Cycle | Typically every 3–5 years |
✅ Tips to Reduce Cost and Time
Leverage existing CE/FDA approvals to reduce duplication
Work with an experienced LAR familiar with Class D documentation
Submit well-structured, complete documentation from the outset
Ensure bilingual labeling and IFU before submission
Monitor SFDA responses closely and reply promptly to queries
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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