Before applying for B-class medical device registration with the Saudi Food and Drug Authority (SFDA), thorough preparation is essential to ensure the process goes smoothly and that all requirements are met. Below is a comprehensive list of the preparatory steps you should take to ensure that your application is complete and compliant:

1. Understand the Regulatory Requirements

1.1 Review SFDA Regulations

• Familiarize yourself with the SFDA Medical Device Regulation (MDR), which sets out the framework for medical device registration in Saudi Arabia.
• Ensure you understand device classification criteria (B-class in this case), as well as the specific requirements for B-class medical devices in Saudi Arabia.

1.2 Check Compliance with SFDA’s Standards

• Ensure your device complies with SFDA’s standards and international medical device standards such as:
  • ISO 13485 (Quality Management Systems for medical devices)
  • ISO 14971 (Risk management)
  • ISO 10993 (Biocompatibility)
  • IEC 60601 (Electrical safety for medical devices)

2. Documentation Preparation

2.1 Prepare Product Documentation

• Product Description: Provide a detailed description of the device, including its intended use, indications, features, and specifications.
• Risk Management File: Complete a risk assessment following ISO 14971. Identify potential risks and mitigation strategies for your device.
• Clinical Data: If applicable, gather or prepare clinical data or evidence that supports the safety and efficacy of the device. While this is more common for higher-risk devices, B-class devices may still require clinical evidence, especially for certain types of devices.
• Manufacturing Information:
  • Provide information about the manufacturing process, quality control, and facility certification (e.g., GMP certification).
  • If the device is manufactured outside Saudi Arabia, ensure the facility complies with recognized Good Manufacturing Practice (GMP) standards, and prepare the relevant certification (e.g., FDA GMP, CE certification).
• Labeling and Packaging: Ensure your product labeling meets SFDA requirements:
  • Labels in Arabic and English.
  • Product name, intended use, contraindications, warnings, and other relevant information.
  • Include the registration number once granted.
• Instructions for Use (IFU): Prepare the IFU in both Arabic and English as required by SFDA. Make sure it includes usage instructions, safety warnings, and maintenance guidelines.

2.2 Establish Authorized Representative

• If your manufacturing site is outside Saudi Arabia, you need a local authorized representative (LAR) in Saudi Arabia to manage your registration and act as your liaison with SFDA.
  • Prepare a letter of appointment for the authorized representative, detailing their responsibilities.

2.3 Prepare Technical File

• Ensure that a technical file is ready, which includes:
  • Design and development data (including pre-market testing and performance data).
  • Compliance with international standards (e.g., ISO, IEC, and other applicable standards).
  • Safety and effectiveness data, including risk management documentation.

3. Confirm Device Classification

• Verify the B-class classification: Confirm that your device qualifies as a B-class medical device based on SFDA’s classification system. B-class devices are typically those that are considered moderate risk but not high risk.
• If you're unsure about the classification, consult SFDA or a regulatory expert to ensure proper classification, as the requirements differ between B-class and other classifications (A, C, or D).

4. Identify the Appropriate Submission Path

4.1 Determine the Required Submission Method

• SFDA offers various pathways for medical device registration, including online and offline submission options. Confirm the correct submission method via the Saudi SFDA e-Portal.
  • e-Portal: SFDA requires all registrations to be submitted via the Saudi FDA e-Portal for medical devices.
  • If you're working with a local authorized representative (LAR), confirm their access to the portal and their role in the submission process.

4.2 Decide on Registration Process

• Full Registration vs. Fast-Track: Understand if your device qualifies for any expedited registration process, especially if it is listed on SFDA’s approved device list or has a CE Mark or FDA clearance.
  • Full Registration: Most devices will undergo full review and evaluation by SFDA.
  • Fast-Track: If the device is low-risk or has been previously authorized in other regions (such as the EU, US, or Japan), it may qualify for a faster review process.

5. Prepare for Inspection (if required)

5.1 Manufacturing Facility Inspection

• SFDA may require an inspection of your manufacturing site, particularly if it is located outside Saudi Arabia. This is typically required for higher-risk devices, but it can also apply to B-class devices under certain circumstances.
• Ensure that your GMP certification and quality control processes are well-documented and up to date.

5.2 Importation and Distribution Network

• Prepare for SFDA inspections of your importation process if you’re importing the device to Saudi Arabia. Your local authorized representative may need to be involved in facilitating this.
• Distribution agreements and arrangements must be in place if you are distributing the device through local distributors or partners.

6. Cost and Payment Preparation

6.1 Understand the Registration Fees

• Familiarize yourself with the registration fees associated with the B-class medical device. SFDA charges fees for the registration and for any subsequent activities like renewals or modifications.
  • Fees may vary depending on the device type and classification.

6.2 Budget for Additional Costs

• Be prepared for any additional costs associated with:
  • Clinical studies or tests (if required).
  • Translation of documents (Arabic and English).
  • GMP inspections (if required).
  • Legal or regulatory consulting (if you are working with a local consultant).

7. Establish Post-Market Surveillance Plans

7.1 Create a Post-Market Surveillance System

• Develop a plan for ongoing post-market surveillance (PMS) of your device once it is approved. This should include:
  • Monitoring for adverse events and product performance in the market.
  • Reporting adverse events to SFDA as required.
  • Conducting regular safety reviews and risk assessments.

7.2 Prepare for Adverse Event Reporting

• Set up a process to track, investigate, and report any adverse events or product complaints that occur after the device is on the market in Saudi Arabia.

8. Regulatory Expertise and Support

8.1 Regulatory Consultant

• It can be beneficial to work with a regulatory consultant who is familiar with the SFDA’s requirements for B-class medical devices. They can help ensure that all your documentation is in order and that your application meets the regulatory standards.

8.2 Communication with SFDA

• Stay in touch with SFDA to clarify any specific questions regarding the registration process or requirements for your B-class medical device.
  • Customer service and support services provided by SFDA are helpful for navigating the registration process.

Contact Us：

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