To register a Class A medical device with the Saudi Food and Drug Authority (SFDA) in Saudi Arabia, you need to meet specific requirements. These requirements ensure that the device complies with local regulations and standards. Here’s a detailed breakdown of the requirements:

1. Classification and Device Information

Confirm Device Classification:

• Ensure that your device qualifies as a Class A medical device, which is considered low-risk. Class A devices typically have minimal impact on the body and are non-invasive.

Device Information:

• Provide a detailed description of the device, including its intended use, design, and function.
• Include technical specifications and any performance data relevant to the device.

2. Manufacturer Information

Manufacturer Details:

• Provide comprehensive information about the manufacturer, including the company name, address, contact details, and the principal place of business.
• Include details about the manufacturing facilities and quality management systems in place.

Quality Management System:

• Evidence of a quality management system, such as ISO 13485 certification, is important but not always mandatory for Class A devices. However, it can facilitate the registration process.

3. Documentation

Technical Documentation:

• Product Specifications: Detailed description, intended use, and technical data.
• Design and Manufacturing Information: Details of the design and manufacturing processes, including any validation and verification activities.
• Risk Management: Risk analysis and management documentation, demonstrating that risks have been assessed and mitigated.

Labeling and Packaging:

• Provide samples or drafts of the device labeling, including instructions for use (IFU) and any other required labeling information.
• Ensure that the labeling complies with SFDA requirements, including language and content.

Compliance Evidence:

• Provide documentation of compliance with international standards if applicable (e.g., CE mark or other certifications).

4. Application Submission

SFDA Unified Electronic Platform (UAE):

• Create an account and submit your registration application through the SFDA Unified Electronic Platform (UAE).
• Complete the online application form with all required information and upload the necessary documents.

Fees:

• Pay the applicable registration fees through the online platform. The fee structure is specified by the SFDA and must be adhered to.

5. Additional Requirements

Local Representation:

• If your company is based outside Saudi Arabia, appoint a local representative or distributor who will be responsible for communicating with the SFDA and managing the registration process on your behalf.

Product Testing:

• Although not always required for Class A devices, the SFDA may request evidence of product testing or validation data to ensure device safety and effectiveness.

Post-Market Surveillance:

• Be prepared to comply with post-market surveillance requirements, including reporting adverse events, device malfunctions, or other issues that arise once the device is on the market.

6. Regulatory Compliance

Follow SFDA Guidelines:

• Adhere to all SFDA guidelines and regulations pertaining to medical device registration. Regularly review the SFDA website or consult with SFDA representatives for updates on regulatory requirements.

Document Updates:

• Ensure that all submitted documents are up-to-date and accurate. Any changes or updates to the device or its documentation must be reported to the SFDA.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn