For registering a B-class medical device with the Saudi Food and Drug Authority (SFDA), compliance with certain standards is essential to ensure the safety, efficacy, and quality of the device. These standards are based on both international regulations and SFDA-specific requirements. Below is a breakdown of the key standards you must meet for the registration of a B-class medical device in Saudi Arabia:

1. International Standards for Medical Devices

SFDA typically aligns its regulatory requirements with globally recognized standards for medical devices. The following are the key international standards that B-class medical devices must comply with:

1.1 ISO 13485: Quality Management Systems (QMS)

• ISO 13485 is a crucial standard for medical devices. It specifies the requirements for a Quality Management System (QMS) in the manufacturing and distribution of medical devices.
• Compliance with ISO 13485 demonstrates that the manufacturer has implemented a quality management system that ensures the device is consistently produced and controlled to meet customer requirements and regulatory standards.
• What it covers:
  • Design and development
  • Manufacturing processes
  • Risk management
  • Post-market surveillance
  • Corrective and preventive actions (CAPA)

1.2 ISO 14971: Risk Management for Medical Devices

• ISO 14971 is the standard for risk management applied to medical devices.
• It requires manufacturers to systematically identify, evaluate, and mitigate potential risks associated with the device during its entire lifecycle.
• What it covers:
  • Risk assessment and analysis
  • Risk control measures
  • Risk management reports
  • Benefits-risk analysis

1.3 ISO 10993: Biological Evaluation of Medical Devices

• ISO 10993 outlines the requirements for biological evaluation of medical devices to ensure that the materials used are safe for patient contact.
• This standard is essential for devices that come into contact with the human body, either externally or internally.
• What it covers:
  • Biocompatibility testing
  • Cytotoxicity, sensitization, and irritation testing
  • Evaluation of the potential effects of the device on the body (e.g., local and systemic toxicity)

1.4 IEC 60601: Electrical Safety of Medical Devices

• IEC 60601 is a series of international standards for the electrical safety and performance of medical electrical equipment.
• Devices that involve electrical components (such as monitoring equipment, diagnostic devices, or therapeutic equipment) must meet the safety and performance requirements of this standard.
• What it covers:
  • Electrical safety
  • EMC (electromagnetic compatibility)
  • Functional performance

1.5 ISO 14155: Clinical Investigation of Medical Devices

• ISO 14155 provides guidelines for the clinical investigation of medical devices. While this standard is more commonly used for high-risk devices, some B-class devices may require clinical data to demonstrate their safety and effectiveness.
• What it covers:
  • Ethical considerations in clinical trials
  • Clinical trial design
  • Data collection and analysis

1.6 ISO 20417: Medical Device Labeling

• ISO 20417 specifies the requirements for the labeling of medical devices, ensuring that all relevant information (e.g., intended use, warnings, instructions) is clearly presented to the user.
• For B-class devices, it is important that labeling meets this standard to ensure the device is used safely.
• What it covers:
  • Labeling content requirements (intended use, warnings, etc.)
  • Use of languages (Arabic and English required for Saudi registration)
  • Symbols and graphical representations

2. SFDA-Specific Requirements for B-Class Medical Devices

In addition to the international standards, Saudi SFDA has specific regulations and requirements that you must meet when registering a B-class medical device. These include:

2.1 SFDA’s Medical Device Regulation (MDR)

• SFDA has its own Medical Device Regulation (MDR), which establishes the guidelines for the marketing, registration, and post-market surveillance of medical devices in Saudi Arabia.
• These regulations cover aspects such as:
  • Device classification (including B-class)
  • Registration procedures and documentation requirements
  • Device labeling and instructions for use
  • Post-market surveillance, reporting of adverse events, and recalls

2.2 SFDA’s Guideline for Medical Device Classification

• SFDA classifies medical devices into four categories based on risk:
  • Class A: Low risk
  • Class B: Moderate risk (devices that require registration but are less risky than high-risk devices)
  • Class C: High risk
  • Class D: Highest risk
• You must confirm that your device qualifies as a B-class device under SFDA's classification system, which considers the intended use, invasiveness, and risk to the patient.

2.3 SFDA’s Post-Market Surveillance Requirements

• SFDA requires manufacturers to have a post-market surveillance (PMS) system in place to monitor the safety and performance of medical devices once they are marketed.
• The PMS must comply with SFDA regulations and may include reporting adverse events, implementing corrective actions, and managing product recalls.

2.4 SFDA’s Good Manufacturing Practice (GMP) Guidelines

• GMP compliance is a key requirement for all medical devices, including B-class devices. The GMP guidelines cover manufacturing practices to ensure that devices are produced to the highest quality and safety standards.
• For manufacturers outside of Saudi Arabia, providing GMP certification from a recognized authority (e.g., FDA, European Union) is generally accepted by SFDA.
• SFDA may require an inspection of the manufacturing site to ensure that GMP standards are being met.

3. Other Relevant Standards and Requirements

3.1 International Standards for Sterilization

• If your device is sterile or uses sterile packaging, you will need to follow relevant sterilization standards. Common standards include:
  • ISO 11135 for ethylene oxide (EtO) sterilization.
  • ISO 17665 for steam sterilization.
  • ISO 11737 for microbiological testing of sterilized medical devices.

3.2 International Electrotechnical Commission (IEC) 60601-1

• This is a safety standard for electrical medical devices.
• If your device is electrical or has electronic components (e.g., diagnostic or therapeutic devices), it must comply with the IEC 60601-1 standard for safety and performance. This includes electrical safety, electromagnetic compatibility (EMC), and overall functional performance.

3.3 Biocompatibility Standards (ISO 10993)

• For medical devices that come into contact with the human body, ISO 10993 standards must be followed to assess the biocompatibility of materials used in the device.

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