A technical file for SFDA medical device registration is a key document that proves a device’s safety, quality, and compliance with the Saudi Food and Drug Authority (SFDA) regulations. A well-prepared file ensures a smoother approval process and faster market entry.
This guide outlines the essential steps and best practices to compile a technical file as per SFDA’s latest 2025 requirements.
What is Technical File in Medical Devices?
A technical file is a structured document that includes essential information about a medical device. SFDA uses this file to assess if a device meets regulatory standards before granting market approval in Saudi Arabia.
5 Steps For Preparing Technical File For SDFA Medical Device Registration
Follow these steps to compile a complete and compliant technical file:
Step 1: Understand SFDA Requirements
Before compiling your technical file, determine:
- Your device’s classification (Class A, B, C, or D).
- The specific regulatory standards it must follow.
- Requirements for testing, labeling, and clinical evaluation.
Staying informed about SFDA guidelines helps prevent errors and delays.
Step 2: Gather Essential Documents
Your technical file must include:
1️⃣ Device Description – Name, model, purpose, and specifications.
2️⃣Labeling and Packaging – Sample labels, packaging, and Instructions for Use (IFU).
3️⃣Design and Manufacturing Information – Drawings, production process, and materials used.
4️⃣Risk Management Report – Risk analysis, safety measures, and mitigation strategies.
5️⃣Testing and Validation Data – Performance tests, biocompatibility studies, and stability reports.
6️⃣Clinical Evaluation Report – Proof of safety and effectiveness through clinical studies.
7️⃣Post-Market Surveillance Plan – Methods for tracking device performance after approval.
Step 3: Structure Your Technical File
To facilitate SFDA review, structure the file in this order:
1️⃣ General Information – Device name, manufacturer details, and intended use.
2️⃣ Technical Description – Drawings, specifications, and materials.
3️⃣ Compliance with Safety Standards – Test reports, risk assessments, and certifications.
4️⃣ Manufacturing Details – Production process, quality control, and facility details.
5️⃣ Labeling and Instructions – Samples of labels, user manuals, and handling instructions.
6️⃣ Clinical and Performance Data – Study reports, clinical evidence, and real-world usage data.
7️⃣ Post-Market Surveillance Plan – How you will track device safety and performance post-approval.
Step 4: Ensure Accuracy and Completeness
Before submitting, double-check that:
✔ All documents are complete and meet SFDA requirements.
✔ Information is clear, consistent, and well-organized.
✔ There are no missing test reports or risk management details.
✔ Clinical and performance data support the device’s intended use.
Step 5: Submit to SFDA for Review
Once the technical file is complete:
- Upload it to the SFDA’s GHAD system.
- Pay the required fees for the review process.
- Monitor your application’s progress on the SFDA portal.
- Respond promptly to any additional information requests from SFDA.
Once approved, your medical device can be marketed in Saudi Arabia.
Best Practices for a Successful Submission
✔ Use Standardized Templates – Maintain a clear, structured document format.
✔ Ensure Accuracy & Completeness – Double-check that all required data is included.
✔ Seek Professional Support – Consulting regulatory experts can help avoid compliance issues.
✔ Stay Updated on SFDA Regulations – Regularly check for any changes in requirements.
How OMC Medical Support
At OMC Medical, we simplify the SFDA technical file preparation process by providing:
➜ Structured templates aligned with SFDA requirements.
➜ Regulatory guidance to ensure compliance.
➜ Expert review services to enhance accuracy and minimize delays.
Conclusion
A well-prepared technical file is critical for SFDA medical device registration. Following SFDA requirements, structuring your file properly, and ensuring accuracy can improve approval chances.
With OMC Medical’s expertise, you can navigate the regulatory process efficiently and with confidence.
FAQs
1. How long does SFDA take to review a technical file?
Review timelines vary depending on the completeness of the submission and device classification. Typically, the SFDA review process can take 3 to 6 months, but delays may occur if additional information or clarifications are requested.
2. What are common reasons for technical file rejection?
Some common issues leading to rejection include:
- Missing or incomplete documents
- Inadequate risk assessment and management
- Lack of supporting clinical data
- Non-compliance with labelling requirements
- Failure to provide post-market surveillance details
3. Do I need to include clinical data in the technical file?
Clinical evaluation reports are mandatory for higher-risk medical devices (Class IIb and Class III). However, for low-risk devices, SFDA may accept equivalent product comparisons or literature reviews as evidence of safety and performance.
4. Should the technical file be submitted in Arabic or English?
The SFDA accepts technical files in English, but labelling and instructions for use (IFU) must be provided in both English and Arabic to comply with local regulations.
5. Can I use an existing EU MDR or FDA technical file for SFDA registration?
While an EU MDR or FDA-compliant technical file can serve as a strong foundation, it must be adapted to meet SFDA-specific requirements, including Arabic labelling, specific risk assessment criteria, and compliance with Saudi medical device regulations.
