What is D-Class Medical Device Registration with the Saudi SFDA?

In the Saudi Arabian regulatory framework, medical devices are classified into four categories based on their risk to the patient and user. D-class devices are low-risk devices that generally have minimal risk when used as intended. These devices may be simple or non-invasive and are typically used in clinical or home settings.

Examples of D-class devices include:

• Non-invasive diagnostic devices (e.g., thermometers, blood pressure monitors).
• Consumables (e.g., bandages, gloves).
• Simple accessories used in conjunction with medical devices.

The Saudi Food and Drug Authority (SFDA) regulates all medical devices sold or marketed in Saudi Arabia. D-class devices are subject to a simplified registration process, compared to higher-risk devices, but still require compliance with the SFDA’s regulatory standards.

D-Class Medical Device Registration Process with SFDA

The process for registering a D-class medical device with the SFDA is relatively straightforward. Here's a breakdown of the steps involved:

1. Eligibility for D-Class Device

• D-class devices are categorized as low-risk devices. This classification is typically for devices that pose a minimal threat to health and safety, such as:
  • Non-invasive devices
  • Devices that do not require significant manipulation or extensive clinical evaluation
  • Devices that are generally used in a routine manner and are considered to have a low risk of causing harm

2. Appoint a Local Authorized Representative

• Foreign manufacturers must appoint a local authorized representative (LAR) in Saudi Arabia to handle the regulatory submission. The LAR acts as the point of contact between the SFDA and the manufacturer for all regulatory matters, including product registration, post-market surveillance, and compliance.
• The LAR must be licensed by the SFDA to represent medical device manufacturers.

3. Compile Required Documentation

The following documents are typically required for registering a D-class medical device with the SFDA:

• Manufacturer Information: Basic company information, including business registration documents.
• Device Information: A detailed description of the device, including intended use, technology, and specifications.
• Device Labeling and User Manual: Copies of the device label, packaging, and user instructions, all in Arabic and English.
• ISO Certification: If applicable, an ISO 13485 certificate (or equivalent) indicating that the manufacturer follows good manufacturing practices.
• Certificate of Free Sale (CFS): A certificate issued by the competent authority in the manufacturer’s home country, stating that the device is legally marketed and available for sale in that country.
• Product Conformity: Declaration of conformity, demonstrating that the device meets the applicable standards (e.g., ISO, IEC).
• Clinical Data: Depending on the type of device, the SFDA may request clinical data or risk assessments to ensure the device is safe for use.
• Testing Reports: If required, include any safety or performance testing results for the device.

4. Submit the Application

• The Saudi Arabian Authorized Representative (LAR) submits the registration application through the SFDA’s Medical Device Electronic Services (MDES) portal.
• The application must be submitted with all required documentation, including the application form, product details, and payment of the registration fee.
• Registration fees for D-class devices are typically lower than for higher-risk devices, but the exact amount will depend on the product and other regulatory considerations.

5. SFDA Review Process

• After submission, the SFDA will review the documentation to ensure that the device complies with Saudi regulations.
• D-class devices generally have a simpler review process compared to higher-risk devices, as they pose a lower risk to health and safety.
• The SFDA may request additional information or clarification if necessary, but the overall review time is typically shorter (around a few weeks to a couple of months).

6. Approval and Issuance of Registration

• Once the SFDA is satisfied with the application, they will issue a registration certificate for the device.
• This certificate allows the device to be legally marketed and sold in Saudi Arabia.
• The registration certificate is usually valid for 5 years, after which it must be renewed.

7. Post-Market Surveillance and Reporting

• After registration, the manufacturer or the local representative must monitor the device’s performance and safety in the market.
• If there are any adverse events or complaints, these must be reported to the SFDA. In some cases, the SFDA may conduct post-market inspections or audits.

Key Points to Remember:

• D-class devices are low-risk devices and typically have a simpler registration process.
• You must appoint a local authorized representative (LAR) in Saudi Arabia if you are a foreign manufacturer.
• The required documentation includes a device description, labeling, free sale certificate, and quality management system certifications.
• D-class devices undergo a simplified review process by the SFDA, and the registration is typically completed within a few weeks to months.
• Regular post-market surveillance and reporting are required for all registered medical devices.

Would you like more information on any specific step of the process?

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn