For A-class medical device registration with the Saudi Food and Drug Authority (SFDA), the device must meet certain standards that ensure it is safe, effective, and compliant with SFDA regulations. While A-class devices are considered low-risk and generally have fewer requirements than higher-risk devices, they still need to comply with specific international standards and SFDA guidelines for medical device registration.

Below are the key standards and guidelines you should be aware of when registering an A-class medical device with the SFDA:

1. SFDA Guidelines and Regulations

• Saudi Medical Device Registration Guidelines: The SFDA provides specific guidelines for the registration of medical devices in Saudi Arabia. These guidelines outline the requirements for A-class, B-class, C-class, and D-class devices, detailing the documentation needed for each classification.
• Saudi Food and Drug Authority (SFDA) Medical Device Regulations: These regulations outline the requirements for medical device manufacturers, importers, and distributors, including requirements for local representation, technical documentation, and post-market surveillance.

2. International Standards Compliance

A-class medical devices must demonstrate compliance with several international standards related to manufacturing, quality control, safety, and risk management. Below are the most relevant ones:

a. ISO 13485: Quality Management System (QMS)

• ISO 13485 specifies the requirements for a quality management system (QMS) for medical devices. This standard ensures that the device is designed, manufactured, and tested to meet specified quality standards.
• Condition: The manufacturer must have a certified ISO 13485 QMS in place, which is commonly required for all medical devices, including A-class devices.

b. ISO 14971: Risk Management

• ISO 14971 provides a framework for managing risks associated with medical devices. This standard applies to all types of devices, including low-risk (A-class) devices, and ensures that risks are identified and mitigated.
• Condition: Manufacturers must conduct a risk assessment based on ISO 14971, ensuring that potential risks associated with the device are properly controlled and mitigated. For A-class devices, this is typically a low-risk evaluation, but it must still be documented.

c. ISO 10993: Biological Evaluation of Medical Devices

• ISO 10993 provides guidelines for the biological evaluation of medical devices, particularly those that come into direct or indirect contact with the body.
• Condition: For A-class devices that have biological interactions (e.g., skin contact or mucosal contact), biocompatibility testing reports may be required to demonstrate the device’s safety.

d. IEC 60601-1: Electrical Safety of Medical Devices

• For electrical medical devices (e.g., diagnostic equipment, monitors), the device must comply with IEC 60601-1, which specifies electrical safety requirements for medical devices.
• Condition: If your A-class device is electrical, it must be tested to meet IEC 60601-1 standards, which include tests for electrical hazards, insulation, leakage currents, etc.

3. Other Relevant Standards

a. ISO 15223-1: Symbols for Use in Labeling

• ISO 15223-1 outlines the symbols that should be used on medical device labeling to convey safety information clearly.
• Condition: Ensure that the labeling of your device complies with the relevant symbols and instructions required by this standard, which may include symbols for the expiration date, batch number, and usage instructions.

b. ISO 14155: Clinical Investigation of Medical Devices

• ISO 14155 provides guidelines for clinical investigations involving medical devices. While A-class devices are typically low-risk and may not require clinical data, manufacturers of devices making therapeutic or diagnostic claims may need to provide clinical evidence of safety and performance.
• Condition: If clinical data is required, the clinical trials should follow the protocols outlined in ISO 14155.

c. ISO 11135: Sterilization of Medical Devices

• For sterile devices, ISO 11135 provides the requirements for sterilization processes, such as ethylene oxide (EO) sterilization.
• Condition: If your A-class device is sterile, ensure that the sterilization process complies with ISO 11135 or another recognized sterilization standard.

d. ISO 11737: Sterility of Medical Devices

• ISO 11737 focuses on sterility assurance levels for medical devices and provides guidance on microbial testing to ensure that devices remain sterile during manufacture and throughout their lifecycle.
• Condition: Devices that are sterile or require sterility testing must comply with this standard to demonstrate their sterility level.

4. SFDA-Specific Requirements

In addition to the international standards, the SFDA has specific requirements and procedures that must be followed for A-class medical device registration:

a. Device Classification

• SFDA Classification: The device must be classified according to the SFDA classification system, which includes A-class (low-risk) and higher-risk classifications (B, C, and D).
• Condition: The manufacturer must confirm that the device meets the criteria for A-class (low-risk) classification as per SFDA guidelines.

b. Labeling Requirements

• SFDA requires that medical device labels include specific information such as the device name, intended use, batch or serial number, manufacturer details, CE mark (if applicable), and storage conditions.
• The language of the labeling and Instructions for Use (IFU) should be in Arabic or English (or both, depending on SFDA’s requirements).

c. Post-Market Surveillance

• SFDA mandates that post-market surveillance systems are in place to monitor the safety and performance of medical devices once they are in the market.
• Condition: Manufacturers and authorized representatives must be prepared to report any adverse events or defective products associated with their devices.

5. Medical Device Establishment License (MDEL)

• To register a medical device with the SFDA, the manufacturer or local authorized representative must hold a valid Medical Device Establishment License (MDEL), which authorizes them to distribute and market medical devices in Saudi Arabia.

Condition:

• If you are a foreign manufacturer, you will need to appoint a local authorized representative who is registered with the SFDA and has an MDEL.

Summary of Key Standards for A-class Medical Device Registration:

1. ISO 13485: Quality Management System (QMS) for medical devices.
2. ISO 14971: Risk management for medical devices.
3. ISO 10993: Biological evaluation (for devices in contact with the body).
4. IEC 60601-1: Electrical safety (for electrical devices).
5. ISO 15223-1: Labeling symbols for medical devices.
6. ISO 14155: Clinical investigations (if applicable).
7. ISO 11135: Sterilization of medical devices (if applicable).
8. ISO 11737: Sterility testing (if applicable).
9. SFDA Medical Device Regulations: Local regulations, including labeling, registration, and post-market surveillance requirements.
10. Medical Device Establishment License (MDEL): Required for local distribution.

By ensuring compliance with these standards and guidelines, you can facilitate the smooth registration of your A-class medical device with the SFDA. Would you like further details on any specific standard or requirement?

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