Expert Medical Devices Regulatory Services in Saudi Arabia
Saudi Arabia represents one of the most rapidly evolving medical device markets in the GCC. To achieve market entry, manufacturers must comply with the Saudi Food and Drug Authority (SFDA) medical device regulations among the most rigorous in the region.
At DDReg, we provide full-spectrum Saudi Arabia Medical Device Registration Services, guiding global manufacturers, importers, and distributors through every stage of SFDA medical device registration. From device classification and dossier compilation to acting as your Saudi Authorized Representative (AR) and ensuring post-market compliance, we help you meet every regulatory milestone with precision.
Whether your need is for medical device registration in Saudi Arabia, IVD device registration, or medical equipment registration, DDReg ensures your products meet SFDA’s safety, quality, and performance expectations.
Why Work with DDReg for SFDA Medical Device Registration in Saudi Arabia?
- Comprehensive regulatory coverage from product classification and conformity assessment to vigilance and renewals.
- Strong expertise in SFDA frameworks including MDMA (Medical Device Marketing Authorization) and MDNR (Medical Device National Registry) processes.
- Saudi Authorized Representative (AR) support for manufacturers without a legal entity in the Kingdom.
- Tailored regulatory strategy to align your device registration approach with both compliance and commercial goals in the region.
- Proven success across multiple device types, from diagnostics to implantables and high-risk medical systems.
Understanding the Saudi Arabia Medical Device Registration Framework
The SFDA governs registration, import, and post-market activities for all medical devices and IVDs in the Kingdom. The process and documentation vary depending on the classification and risk level of the device.
| Risk Class | Description | Regulatory Pathway | Validity |
|---|---|---|---|
| Class A (Low Risk) | Non-sterile / non-measuring devices | MDNR Listing | 3 years |
| Class B (Medium Risk) | Moderate-risk devices | MDMA Approval | Up to 3 years |
| Class C (High Risk) | Invasive or implantable devices | MDMA Approval + CAB review | Up to 3 years |
| Class D (Highest Risk) | Critical or life-supporting devices | MDMA Approval + Full Dossier | Up to 3 years |
- QMS Certification: ISO 13485:2016
- Local Authorized Representative: Mandatory for foreign manufacturers
- Technical Documentation: Product description, CER, labeling (English & Arabic), UDI, IFU
- Submission Platform: GHAD system (online SFDA portal)
- Labeling: Must comply with Article 18 of the Interim Regulation
Our Medical Device Regulatory Services in Saudi Arabia
- Saudi Arabia medical device registration & lifecycle management
- Regulatory pathway and classification assessment
- SFDA medical device registration consulting (MDNR / MDMA)
- Authorized Representative (AR) services and establishment licensing
- QMS & conformity documentation (ISO 13485) review and readiness
- Technical file & dossier compilation per SFDA requirements
- GHAD portal submission and SFDA communication
- Labeling, UDI, and Arabic translation compliance
- Post-market vigilance, renewals, and variations
- Regulatory intelligence and SFDA updates monitoring
Our Expertise Covers in Medical Devices Regulatory Services in Saudi Arbia:
- Medical Devices and IVDs (in-vitro diagnostics)
- Medical Equipment Registration in Saudi Arabia
- Software as a Medical Device ( SaMD)
- Combination products and high-risk devices
Our local and global teams collaborate to ensure your SFDA submissions meet every requirement efficiently and transparently.