Before applying for D-class medical device SFDA registration in Saudi Arabia, manufacturers or distributors must make thorough preparations to ensure compliance with the Saudi Food and Drug Authority (SFDA) requirements. D-class devices are high-risk medical devices, so the preparation process is particularly detailed and requires meticulous attention to regulatory, technical, and legal aspects.

Here are the key preparations required before applying for D-class medical device SFDA registration:

1. Ensure Compliance with SFDA Regulations

• Understand the SFDA Regulatory Framework: Familiarize yourself with the SFDA Medical Device Regulations and any other relevant guidelines, such as the GCC Medical Device Regulations (GSO 1500). These guidelines outline the legal and procedural requirements for registering medical devices in Saudi Arabia.
• Classification: Verify that the device is correctly classified as D-class. D-class devices are considered high-risk, and SFDA will have specific requirements for these devices. If there’s any doubt about classification, consult with SFDA or regulatory consultants for guidance.

2. Obtain ISO Certifications

• ISO 13485:2016: Ensure your organization holds a valid ISO 13485:2016 certification, which is essential for all medical device manufacturers. This standard covers Quality Management Systems (QMS) and ensures your manufacturing processes meet global standards for safety, effectiveness, and quality.
• ISO 14971: Prepare documentation demonstrating compliance with ISO 14971 (Risk Management for Medical Devices). D-class devices require thorough risk management due to their high-risk nature.
• ISO 10993: If your device comes into direct or indirect contact with the human body (e.g., implantable devices), ensure that you have biocompatibility testing results that comply with ISO 10993 (Biological Evaluation of Medical Devices).

3. Prepare Technical Documentation (Technical File)

The Technical File is a comprehensive set of documents that demonstrate the device’s safety, performance, and regulatory compliance. Key documents that should be included are:

• Device Description: Detailed information about the device, including its intended use, design, components, and technological characteristics.
• Manufacturing Process: Detailed documentation of the manufacturing process, including compliance with Good Manufacturing Practices (GMP) and adherence to ISO 13485.
• Risk Management: A complete risk management file in accordance with ISO 14971. This file should outline the identification, assessment, and mitigation of risks associated with the device.
• Clinical Data: Depending on the device, clinical evidence may be required to demonstrate safety and performance. If the device has been marketed in other jurisdictions (e.g., EU, US), clinical data from those regions may be used. Otherwise, new clinical trials may be required.
• Performance Testing: Results of performance and safety tests, such as mechanical testing, electrical testing (for devices with electrical components), and any other testing relevant to the device’s intended use.
• Biocompatibility Testing: If applicable, include the results of ISO 10993 testing to demonstrate that the materials used in the device are safe for human contact.
• Sterility Data: If the device is sterile, provide data demonstrating that it has been properly sterilized and maintained in sterile conditions.
• Labelling and IFU: Prepare device labeling and Instructions for Use (IFU). Labels should comply with SFDA requirements, including Arabic translations. The IFU should clearly outline the device’s intended use, contraindications, risks, and operating instructions.
• Software Documentation: If the device includes software, ensure that you provide documentation in accordance with IEC 62304 (software life cycle processes) and IEC 60601-1-2 (electromagnetic compatibility for medical electrical equipment).

4. Establish Local Representation (If Applicable)

• Authorized Representative: If you are a foreign manufacturer, you must appoint a local authorized representative (AR) in Saudi Arabia to act as the liaison between the manufacturer and SFDA. The AR will submit the registration application on your behalf and be responsible for compliance with local regulations.
• The AR should be a company registered with the SFDA and must have a clear understanding of SFDA regulations and processes.

5. Prepare for Clinical Evaluation (If Required)

• Clinical Evaluation Report (CER): For high-risk devices like D-class devices, you may need to provide a Clinical Evaluation Report that summarizes the results of clinical investigations or data that supports the device’s safety and performance.
• Clinical Trials: If required, you will need to provide data from clinical trials that have been conducted following ethical guidelines and international standards (e.g., ISO 14155).

6. Determine Product Labeling Compliance

• Labeling Requirements: Ensure that the product labeling complies with SFDA requirements, which include:
  • Arabic Translations: All labeling must be in Arabic, including the device’s name, intended use, manufacturer details, warnings, instructions, and any other relevant information.
  • Symbols: Use ISO 15223-1 symbols where applicable to provide critical information in a standardized format.
  • Unique Device Identifier (UDI): Ensure that the device complies with any applicable UDI requirements, as part of SFDA’s traceability and post-market surveillance efforts.

7. Review Device Classification and Intended Use

• Intended Use: Confirm that the device’s intended use is clearly defined, as this will impact both its classification and the type of documentation needed for registration.
• Labeling and Claims: Review the device claims to ensure that they align with the intended use and SFDA’s guidelines. Overstated claims can lead to rejection or delays in approval.

8. Compile Regulatory Submission Package

• The SFDA registration application package must include all required documentation, including:
  • Registration Application Form: Complete and sign the SFDA registration application form.
  • Device Description: Information on the device, including its intended use, design, and regulatory status in other markets.
  • Manufacturing Information: Details of the manufacturing process and quality control procedures.
  • Risk Management: Evidence of compliance with ISO 14971.
  • Clinical Data: If required, provide clinical data to demonstrate the device’s safety and effectiveness.
  • Testing Reports: Provide performance, biocompatibility, and sterility testing reports as applicable.

9. Evaluate Regulatory Requirements for Importation

• Importer License: If the device is being imported into Saudi Arabia, the local importer or distributor will need to hold an SFDA-issued Importer License. Ensure the importer is registered with the SFDA and complies with local importation regulations.

10. Ensure Financial Readiness for Application Fees

• The application process for D-class medical devices can involve significant fees. Be prepared to pay registration, evaluation, and possibly inspection fees as part of the application process. Make sure to check the current fee structure on the SFDA website or consult with an SFDA representative.

11. Prepare for SFDA Inspections (If Applicable)

• On-Site Inspection: SFDA may require an on-site inspection of your manufacturing facility, especially for high-risk devices. Ensure that your facility is compliant with all GMP requirements, ISO 13485 standards, and any other relevant regulations.
• If you are a foreign manufacturer, the SFDA may conduct an inspection of the overseas facility, either through a direct visit or by collaborating with local authorities.

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