Before applying for A-class medical device registration with the Saudi Food and Drug Authority (SFDA), there are several important preparations you need to make to ensure a smooth and efficient registration process. These preparations involve gathering the necessary documents, ensuring compliance with regulatory requirements, and understanding the SFDA's specific procedures.

Here is a checklist of the key preparations you should undertake:

1. Confirm Device Classification

Before starting the application process, confirm that your device qualifies as an A-class (low-risk) device under the SFDA’s classification system.

• Review SFDA Classification Criteria: Ensure your device falls into the A-class category by checking SFDA’s classification guidelines. A-class devices are typically low-risk devices, such as simple non-invasive devices.
• Classify the Device Correctly: Misclassification can delay the registration process. If in doubt, consult with an expert or SFDA directly.

2. Appoint a Local Authorized Representative (for Foreign Manufacturers)

If your company is based outside Saudi Arabia, you must have a local authorized representative in Saudi Arabia.

• Select a Licensed Representative: Choose a representative who is registered with SFDA and holds a valid Medical Device Establishment License (MDEL).
• Establish a Formal Agreement: You must formalize the relationship with the local representative through a signed agreement that outlines their responsibilities in the registration process and ongoing compliance.

3. Gather and Prepare Technical Documentation

Prepare the technical documentation for the device. This documentation will be crucial to prove that the device meets the necessary safety and performance requirements as outlined by SFDA.

Key documents include:

• Product Description: Detailed description of the device, including its intended use, design, materials, and functionality.
• Risk Management File: Documentation demonstrating compliance with ISO 14971 for risk management.
• Clinical Evaluation Report (if applicable): Although A-class devices generally do not require clinical trials, if your device makes certain claims (e.g., therapeutic claims), you may need clinical data.
• Design and Manufacturing Information: Including information on the manufacturing process, quality control, and testing procedures.
• ISO 13485 Certification: Certification for the Quality Management System (QMS), which is necessary for compliance with SFDA regulations.
• Biocompatibility Documentation: For devices that come into contact with the body, compliance with ISO 10993 for biological evaluation may be required.
• Electrical Safety Reports: If the device is electrical, ensure it complies with IEC 60601-1 (electrical safety) standards.

4. Verify Compliance with Labeling and Packaging Requirements

Ensure that the labeling and packaging of your device comply with SFDA regulations, which include:

• Labeling in Arabic: Ensure that the device label includes Arabic language information (e.g., product name, manufacturer details, intended use, warnings, expiration date, etc.).
• CE Marking (if applicable): If the device has a CE mark, include it on the label. The CE mark is required for devices marketed in the European Economic Area (EEA) and may be accepted by SFDA, depending on the device and its risk level.
• Instructions for Use (IFU): Ensure that the IFU is written in Arabic (and optionally in English) and includes clear instructions on how to safely use the device, warnings, and contraindications.
• Regulatory Symbols: Ensure that the labeling uses the correct regulatory symbols as per ISO 15223-1.

5. Ensure Product Compliance with SFDA Standards

Make sure your device complies with international and SFDA-specific standards related to its design, manufacture, and intended use.

Key standards include:

• ISO 13485: Quality management system.
• ISO 14971: Risk management.
• ISO 10993: Biocompatibility (if applicable).
• IEC 60601-1: Electrical safety (if applicable).
• ISO 11135 and ISO 11737: Sterilization and sterility testing (if applicable).

Ensure that these standards are properly documented and available for submission.

6. Prepare Regulatory Fees and Payment

Make sure you understand the SFDA's fee structure for the medical device registration process and have the necessary funds available for payment.

• Check Registration Fees: Verify the registration fees for A-class devices with SFDA. The fees may vary depending on the device type, and the SFDA website or your authorized representative can provide the latest fee details.
• Prepare for Payment: Ensure that you have a payment method ready for the application submission process, as the SFDA typically requires payment during the registration procedure.

7. Review Post-Market Surveillance Requirements

Understand the post-market surveillance requirements for A-class medical devices in Saudi Arabia. SFDA has stringent requirements for monitoring the safety and performance of medical devices once they are in the market.

• Plan for Reporting Adverse Events: Be prepared to report any adverse events or product defects once your device is on the market.
• Prepare for Recalls (if applicable): Have a plan in place in case the device needs to be recalled due to safety or performance issues.
• Establish a Post-Market Surveillance System: SFDA requires that manufacturers monitor their device's performance and safety after it is sold, and this must be documented.

8. Prepare for SFDA’s Application Portal

The SFDA registration process is primarily handled through the SFDA’s Medical Device Registration System (MDRS). Make sure you are familiar with the portal and its requirements before starting the application process.

• Create an Account on the SFDA Portal: If you don’t already have one, create a user account on the SFDA portal.
• Understand the Submission Process: Familiarize yourself with the steps for submitting your application and the required information.
• Digital Certificates (if required): Ensure you have the necessary digital certificates for submitting documents electronically (if required by SFDA).
• Review SFDA’s Submission Guidelines: Carefully read SFDA’s submission guidelines for any specific formatting or document size requirements.

9. Verify Validity of Your Medical Device Establishment License (MDEL)

If you are a local distributor or authorized representative, ensure that you have a valid MDEL to act on behalf of the manufacturer.

• Ensure the MDEL is Active: The MDEL must be valid at the time of registration and throughout the life of the device on the Saudi market.
• Compliance with SFDA Requirements: Ensure that the MDEL holder complies with all SFDA regulations regarding medical device distribution.

10. Prepare for Inspections (if applicable)

Although A-class devices are generally lower-risk and less likely to undergo full inspections, SFDA may still conduct site inspections.

• Prepare Documentation: Ensure that all required documentation (such as manufacturing records, risk management files, and QMS certificates) is ready for inspection if requested by SFDA.
• Quality Control and Compliance: Make sure that your manufacturing processes and facilities comply with ISO 13485 and SFDA’s Good Manufacturing Practice (GMP).

Summary Checklist of Preparations:

1. Device Classification: Confirm A-class classification.
2. Local Representative: Appoint a licensed local authorized representative (for foreign manufacturers).
3. Technical Documentation: Prepare all necessary technical files (e.g., product description, risk management, ISO certifications).
4. Labeling and Packaging: Ensure compliance with SFDA's labeling requirements, including Arabic language and regulatory symbols.
5. International Standards Compliance: Ensure compliance with relevant standards (e.g., ISO 13485, ISO 14971, IEC 60601).
6. Regulatory Fees: Understand and prepare for registration fees.
7. Post-Market Surveillance: Develop systems for monitoring safety and performance after market introduction.
8. SFDA Portal Familiarization: Set up an account and understand the submission process on the SFDA portal.
9. MDEL: Ensure that the authorized representative has an active Medical Device Establishment License (MDEL).
10. Inspections: Be prepared for inspections and audits if necessary.

By following these preparations, you can ensure that your application for A-class medical device registration with the SFDA is thorough and compliant, helping to streamline the approval process. Let me know if you need further details on any specific step!

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