To register a Class A medical device with the Saudi Food and Drug Authority (SFDA), you need to prepare and submit specific materials. Here’s a detailed list of required materials and guidance on preparing the application documents:

Required Materials

1. Device Information

• Device Description: Detailed overview of the device, including its design, functionality, and intended use.
• Technical Specifications: Information on device performance, materials used, and any applicable standards.
• Device Classification: Documentation supporting the classification of the device as Class A.

2. Manufacturer Information

• Company Profile: Name, address, and contact details of the manufacturer.
• Manufacturing Facilities: Information on the manufacturing site, including any relevant quality management certifications.

3. Quality Management System (QMS)

• Certification: Evidence of a quality management system (e.g., ISO 13485) if applicable, though not always mandatory for Class A devices.

4. Labeling and Packaging

• Labels: Samples or drafts of the product labels that comply with SFDA requirements.
• Instructions for Use (IFU): Clear, comprehensive user instructions that accompany the device.

5. Compliance Documentation

• International Certifications: If applicable, provide evidence of compliance with international standards or certifications, such as CE marking.
• Risk Management: Documentation of risk analysis and management related to the device.

6. Local Representation (if applicable)

• Local Representative Details: If your company is not based in Saudi Arabia, provide information about a local representative or distributor.

7. Supporting Documents

• Declaration of Conformity: A statement from the manufacturer affirming that the device complies with relevant regulations and standards.
• Test Reports: Any relevant testing data or reports demonstrating the device’s safety and efficacy.

Preparing the Application Documents

1. Gather Information:

• Collect and organize all the necessary information and documents about the device and manufacturer.

2. Format and Translate Documents:

• Ensure that all documents are in the required format and, if necessary, translated into Arabic. Verify translation accuracy.

3. Complete the Application Form:

• Access the SFDA Unified Electronic Platform (UAE) at SFDA Portal.
• Fill out the online application form with accurate and complete information. Include details from the device and manufacturer documentation.

4. Upload Documents:

• Scan and upload all required documents to the SFDA UAE platform. Ensure that the files are clear and legible.

5. Review and Verify:

• Double-check all submitted information and documents for accuracy and completeness before final submission.

6. Pay Fees:

• Pay the required registration fee through the SFDA UAE platform. Make sure to keep a record of the payment.

7. Submit Application:

• Submit the completed application and documents through the SFDA UAE platform. Confirm submission and track the application status.

8. Respond to Queries:

• Be prepared to provide additional information or clarification if requested by the SFDA during the review process.