For Class C medical device registration with the Saudi Food and Drug Authority (SFDA), the device must meet certain standards and regulatory requirements to demonstrate safety, efficacy, and quality. These standards ensure that the device complies with international best practices and regulatory frameworks, and that it poses minimal risk to patients and users. Below are the key standards that apply to Class C medical device registration with the SFDA:

1. ISO 13485:2016 - Quality Management Systems (QMS)

• ISO 13485 is a crucial standard for medical device manufacturers, demonstrating that they follow best practices in quality management throughout the entire product lifecycle.

• This certification confirms that the manufacturer has a robust system for designing, producing, and monitoring medical devices, ensuring compliance with both international regulations and SFDA requirements.

• Key Elements of ISO 13485:

  • Design controls and validation.
  • Supplier management.
  • Traceability of product and components.
  • Risk management processes.
  • Corrective and preventive actions (CAPA).
  • Document control and record-keeping.

2. ISO 14971:2019 - Risk Management for Medical Devices

• ISO 14971 is the standard for risk management related to medical devices. For Class C devices, manufacturers must identify, assess, and manage risks throughout the product lifecycle.

• Key Elements of ISO 14971:

  • Risk assessment: Identifying potential hazards associated with the device and its use.
  • Risk control: Implementing measures to reduce or eliminate risks to an acceptable level.
  • Post-market monitoring: Implementing a system to collect and review data on device performance after it is marketed.
  • Risk analysis and mitigation strategies.
  • Continuous improvement in risk management processes.

3. ISO 10993 - Biological Evaluation of Medical Devices

• ISO 10993 outlines the biocompatibility testing requirements for medical devices. This is particularly important for Class C devices that involve direct or prolonged contact with the human body, such as implants, surgical instruments, and diagnostic devices.

• Key Elements of ISO 10993:

  • Biological evaluation of materials that come in contact with human tissues (e.g., skin, mucosal membranes, blood).
  • Toxicity testing (e.g., cytotoxicity, genotoxicity, sensitization, irritation).
  • Implantation studies: Testing for long-term biocompatibility if the device is an implant.
  • Sterility and endotoxin testing (if applicable).

• Manufacturers must ensure that all devices meet biological safety standards to prevent adverse reactions.

4. IEC 60601 - Electrical Safety for Medical Devices

• For Class C devices that are electrically powered, compliance with IEC 60601 is essential. This standard covers the safety and performance of medical electrical equipment.

• Key Elements of IEC 60601:

  • Electrical safety: Ensures that devices meet safety standards for electrical hazards (e.g., electrical shock, overheating).
  • Electromagnetic compatibility (EMC): Ensures that devices do not emit harmful electromagnetic interference and are immune to external interference.
  • Functional safety: Ensures that electrical devices operate reliably under specified conditions.

• IEC 60601-1: General safety requirements for medical electrical equipment.

• IEC 60601-1-2: EMC requirements for medical electrical equipment.

5. ISO 14155:2020 - Clinical Investigation of Medical Devices

• For Class C devices that require clinical evidence to demonstrate safety and efficacy, ISO 14155 provides the guidelines for the design and conduct of clinical investigations of medical devices.

• Key Elements of ISO 14155:

  • Protocol development and ethics committee approval.
  • Informed consent procedures for clinical trial participants.
  • Data collection and analysis methods.
  • Safety reporting, adverse events, and study termination.

• Clinical investigations must adhere to ethical guidelines and regulatory requirements set by the SFDA and international standards.

6. ISO 7100 - Packaging for Medical Devices

• ISO 7100 outlines requirements for the packaging of medical devices, particularly for sterile and implantable devices.

• Key Elements:

  • Packaging must protect the device from contamination or damage during storage, transportation, and use.
  • Packaging materials must be biocompatible and compatible with the device.
  • Packaging must be designed to maintain sterility (for sterile devices).
  • It should also ensure that the device is easily identifiable and traceable.

7. SFDA Medical Device Regulations

• The SFDA Medical Device Regulations are the primary regulatory framework for medical devices in Saudi Arabia. These regulations establish requirements for:
  • Device registration and classification.
  • Post-market surveillance (adverse event reporting, recalls).
  • Good Manufacturing Practice (GMP).
  • Clinical trials and evaluation.
  • Labeling and packaging standards.
• The regulations outline the specific classification criteria, such as for Class C devices, which typically involve medium-risk medical devices (e.g., diagnostic devices, implants) and require more detailed clinical evidence and risk management processes.

8. SFDA Guidelines on Medical Device Labeling

• The SFDA Medical Device Labeling Guidelines require that labeling must meet both Saudi-specific and international standards. This includes:
  • Intended use, indications, contraindications, and precautions.
  • Manufacturer’s details.
  • Storage conditions.
  • Expiration dates and batch numbers.
  • Warnings and precautions.
  • Arabic and English labeling for user understanding.

9. International Standards for Sterility and Cleanliness

• For devices requiring sterility, compliance with ISO 11135 (for ethylene oxide sterilization), ISO 11137 (for radiation sterilization), and ISO 17665 (for steam sterilization) is required.
• The sterility standards ensure that devices meet the required sterilization process without compromising safety or performance.

10. SFDA Post-Market Surveillance and Vigilance Requirements

• Post-market surveillance is a critical component of the SFDA regulatory framework. Manufacturers must be prepared to monitor the safety of the device after it has been placed on the market.
• This includes requirements for:
  • Reporting of adverse events.
  • Corrective actions such as recalls or modifications to the device.
  • Maintaining records of incidents related to device failure or harm.

11. Labeling and User Instructions

• Devices must meet SFDA guidelines for labeling and user instructions, which must be provided in both Arabic and English.
• The user manual (IFU) should include all safety information, device handling instructions, and details of the correct use of the device.

Summary of Key Standards for Class C Medical Devices in Saudi Arabia

1. ISO 13485 – Quality management system.
2. ISO 14971 – Risk management.
3. ISO 10993 – Biocompatibility and biological evaluation.
4. IEC 60601 – Electrical safety for medical devices.
5. ISO 14155 – Clinical investigations of medical devices.
6. ISO 7100 – Packaging for medical devices.
7. SFDA Medical Device Regulations – Regulatory compliance for registration.
8. SFDA Labeling Guidelines – Device labeling and user instructions in Arabic and English.
9. Post-Market Surveillance Requirements – Adverse event reporting and device monitoring.
10. Sterilization Standards – If applicable, device sterilization in accordance with international standards.

Manufacturers seeking Class C medical device registration with the SFDA must demonstrate compliance with these standards to ensure the device’s safety, effectiveness, and regulatory compliance. Each standard addresses a different aspect of the device's lifecycle, from development to post-market surveillance.

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