The Saudi Food and Drug Authority (SFDA) has been continuously updating its standards and processes for medical device registration, especially in response to international regulatory changes and evolving healthcare needs. For Class C medical devices, which are considered medium-risk devices, the process and requirements for registration are more stringent than those for lower-risk classes but less demanding than for Class D devices (high-risk).

Here’s an overview of the updated standards and process for Class C medical device registration with the Saudi SFDA:

Updated Standards for Class C Medical Device Registration

1. ISO 13485:2016 Compliance

   • Quality Management System (QMS): Manufacturers must have a certified ISO 13485:2016 QMS in place. This standard ensures that the manufacturing processes meet regulatory requirements and consistently produce safe and effective devices. The SFDA increasingly places emphasis on this certification during the registration process.

2. International Standards

   • ISO 14971:2019: This standard on risk management must be followed. It involves identifying, assessing, and mitigating risks associated with medical devices throughout their lifecycle.
   • ISO 10993: For devices that come into contact with the body (e.g., implants), biocompatibility testing must comply with ISO 10993 standards. It includes tests for cytotoxicity, sensitization, irritation, and other biological risks.
   • IEC 60601: For electrically powered devices, compliance with the IEC 60601 series of standards (for medical electrical equipment) is required. This includes standards for electrical safety, electromagnetic compatibility (EMC), and performance.

3. Clinical Data Requirements

   • Clinical Evaluation: Class C devices often require clinical data to demonstrate safety and efficacy. This may include clinical trial data, literature reviews, or other forms of clinical evidence that align with the ISO 14155 standard for clinical trials.
   • Clinical Trial Approval: If clinical trials are required, they must be conducted under Good Clinical Practice (GCP) guidelines and receive approval from the SFDA or a recognized ethics committee before proceeding.

4. Risk Management Plan

   • A comprehensive risk management plan (following ISO 14971) must be submitted. This plan should outline how risks will be identified, assessed, controlled, and monitored during the lifecycle of the device.

5. Updated Labeling Requirements

   • Bilingual Labeling: All medical device labeling, including Instructions for Use (IFU) and packaging, must be available in both Arabic and English. This ensures the device is accessible and understandable to healthcare professionals and patients in Saudi Arabia.
   • Specific Requirements: SFDA has introduced more detailed requirements on labeling, which include more specific warnings, safety instructions, and traceability information.

6. Post-Market Surveillance (PMS) and Vigilance

   • PMS Plans: Manufacturers must have a post-market surveillance system in place to monitor the performance of the device after it enters the market. This includes reporting any adverse events and issues to the SFDA.
   • Vigilance Requirements: Adverse event reporting and incident tracking must comply with SFDA’s vigilance system. If a serious issue arises, it must be reported to the SFDA within 15 days of detection.

7. Risk-Benefit Analysis

   • Risk-Benefit Assessment: For Class C devices, SFDA may require a clear risk-benefit analysis to ensure that the benefits of the device outweigh any potential risks, especially if there are known safety concerns or adverse events in clinical use.

8. Manufacturing and Good Manufacturing Practices (GMP)

   • The GMP certification of manufacturing facilities is crucial. The SFDA may inspect both domestic and international facilities to verify compliance with GMP standards. This process has become stricter, with more focus on compliance with international manufacturing standards and product consistency.

Updated Process for Class C Medical Device Registration

The registration process for Class C medical devices with the SFDA involves several steps. These steps have been streamlined but require thorough documentation and compliance with the latest regulations.

1. Pre-Application Preparations

• Appoint an Authorized Representative: If the manufacturer is outside of Saudi Arabia, they must designate a local authorized representative in Saudi Arabia to manage the registration process and handle post-market responsibilities.
• Review SFDA’s eServices Portal: Before beginning the application, ensure you are familiar with the SFDA eServices portal, where all submissions, queries, and payments will be processed.
• Prepare Required Documents: As discussed, ensure the following documents are prepared:
  • Device description and classification.
  • ISO 13485:2016 certification.
  • Risk management plan (ISO 14971).
  • Clinical data (if applicable).
  • Biocompatibility and safety test results (ISO 10993).
  • Manufacturing site inspection certification (GMP).
  • Product labeling in Arabic and English.
  • Instructions for Use (IFU) in both languages.

2. Submission Process

• Online Application via eServices Portal: Submit your registration application and required documents via the SFDA’s eServices portal.
• Payment of Registration Fees: Pay the relevant registration fees online as part of the application process. These fees are typically based on the type of device and the complexity of the application.

3. Technical and Clinical Review

• Evaluation by SFDA Experts: The SFDA will evaluate your application for compliance with Saudi regulations and international standards. This process may take several months, depending on the complexity of the device and the completeness of your documentation.
• Request for Additional Information: If the SFDA needs additional information, you will be notified and required to provide clarifications or supplemental documents. This can include additional clinical trial data, updated risk assessments, or changes to labeling.
• Inspection of Manufacturing Facility: For non-Saudi manufacturers, the SFDA may inspect the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP). If your manufacturing site is in Saudi Arabia, ensure that it is ready for SFDA inspection.

4. Approval or Rejection

• Device Registration Approval: If the device complies with all requirements and the review is successful, the SFDA will issue device registration approval, allowing you to legally market the device in Saudi Arabia.
• Registration Certificate: Upon approval, you will receive a registration certificate, which is valid for five years. This certificate will include details about the device, such as its classification, intended use, and registration number.

5. Post-Market Compliance

• Market Surveillance: After the device is approved, manufacturers must implement a post-market surveillance (PMS) system. This includes monitoring the device's safety, reporting adverse events, and addressing complaints.
• Periodic Safety Update Reports (PSUR): For certain Class C devices, the SFDA may request periodic safety reports to evaluate the ongoing risk-benefit profile of the device.
• Adverse Event Reporting: If any issues arise post-market, manufacturers are required to report them to the SFDA. This includes product defects, adverse reactions, or other significant issues that could affect patient safety.

6. Renewal Process

• 5-Year Renewal: Medical device registration in Saudi Arabia is valid for five years. To maintain market access, manufacturers must apply for renewal prior to expiration. This involves submitting updated clinical data, safety reports, and GMP compliance certificates.
• Regulatory Updates: During the renewal process, manufacturers must ensure compliance with any updated regulations, which could include changes to standards, clinical evidence requirements, or post-market surveillance protocols.

Summary of Key Updates for Class C Medical Device Registration

1. ISO 13485 certification is mandatory for the manufacturer's QMS.
2. Clinical data may be required to demonstrate safety and efficacy, especially for higher-risk Class C devices.
3. The risk management plan (following ISO 14971) and biocompatibility testing (ISO 10993) are crucial.
4. Compliance with international standards such as IEC 60601 for electrical safety, ISO 14971 for risk management, and ISO 10993 for biocompatibility.
5. Labeling must be in both Arabic and English, meeting SFDA’s specific regulatory requirements.
6. Post-market surveillance systems are required, including adverse event reporting and the submission of Periodic Safety Update Reports (PSURs).
7. The process involves electronic submission via the SFDA’s eServices portal, payment of registration fees, and the potential need for GMP inspections of the manufacturing facility.

By following these updated standards and processes, manufacturers can ensure a smooth registration experience and maintain ongoing compliance with Saudi regulations for Class C medical devices.