B-class medical device registration with the Saudi Food and Drug Authority (SFDA) refers to the process of obtaining regulatory approval to market and distribute Class B medical devices in Saudi Arabia. Class B devices are categorized by SFDA as moderate-risk devices. These devices require a registration process to ensure they meet safety, performance, and quality standards before being sold in the Saudi market.

What Does "Class B" Mean?

In the context of SFDA’s classification system, medical devices are categorized based on their risk level, with Class A being low-risk devices and Class D being high-risk devices. Class B devices are considered to be moderate risk, and the regulatory requirements for these devices are less stringent than those for higher-risk Class C or Class D devices, but more stringent than for Class A devices.

Class B devices are typically those that are used in non-invasive procedures and may include products such as:

• Diagnostic devices
• Certain surgical instruments
• Medical equipment that doesn’t support or sustain life but is still essential for managing health conditions.

Why Is Registration Required for B-Class Devices?

Registration with the SFDA is required to ensure that devices:

• Are safe for use.
• Perform as intended.
• Comply with international standards (such as ISO 13485 for quality management and ISO 14971 for risk management).
• Have appropriate labeling, instructions, and warnings for use.

The registration process allows the SFDA to evaluate the device’s safety and effectiveness, ensuring it meets the regulatory and compliance requirements before it is introduced into the Saudi market.

Steps in the B-Class Device Registration Process:

1. Pre-Registration Preparation: Before applying, manufacturers must classify the device correctly (Class B) and appoint a Local Authorized Representative (LAR) in Saudi Arabia (if the manufacturer is outside of Saudi Arabia).

2. Submission of Application: The manufacturer or their authorized representative submits an application via the SFDA portal, which includes detailed information about the device, its intended use, and supporting documentation.

3. Required Documentation: Includes:

   • Product labeling (in Arabic and English).
   • Clinical data to support the device’s safety and efficacy (if applicable).
   • Risk management documentation.
   • Quality Management System (QMS) certification (ISO 13485).
   • Test reports (e.g., biocompatibility, electrical safety, etc.).

4. Review and Approval: SFDA reviews the submitted documents and may request additional information or clarification. If the device meets all regulatory requirements, SFDA will issue a Certificate of Registration.

5. Post-Approval Requirements: After approval, the device must be monitored in the market, and the manufacturer must adhere to SFDA’s post-market surveillance requirements.

6. Annual Renewal: The registration is valid for one year, and the device must be renewed annually to remain compliant with SFDA regulations.

Why Is B-Class Registration Important?

• Market Access: Without SFDA registration, a medical device cannot be marketed or sold in Saudi Arabia.
• Regulatory Compliance: The registration ensures that devices comply with local laws, standards, and regulations.
• Consumer Safety: It ensures that medical devices available in the market are safe and effective for use by patients and healthcare providers.

Conclusion

In summary, B-class medical device registration with SFDA is a necessary regulatory step for manufacturers wishing to market their moderate-risk medical devices in Saudi Arabia. The registration process involves submitting comprehensive documentation about the device, ensuring it meets safety and performance standards, and complying with post-market monitoring and reporting requirements.

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