The timeframe for obtaining A-class medical device registration with the Saudi Food and Drug Authority (SFDA) typically varies based on the completeness of the application, the complexity of the device, and the workload of the SFDA. However, in general, the process can take anywhere from 4 to 12 weeks from the submission of the application to the final approval, assuming there are no major issues or requests for additional information.

Breakdown of the Timeframe:

1. Initial Review (1-2 weeks):

   • After the application is submitted via the SFDA e-Portal, the initial review takes place. During this stage, the SFDA checks the basic requirements, such as completeness of documents, correct application format, and whether all necessary information is included.
   • If the application is complete and meets the basic submission requirements, the SFDA will proceed to a detailed review.

2. Detailed Review and Evaluation (2-6 weeks):

   • The SFDA's medical device reviewers will evaluate the technical documentation, clinical evaluation, risk management data, labeling, and other key details about the device.
   • This includes checking for compliance with international standards, such as ISO 13485 for quality management systems and ISO 14971 for risk management.
   • The SFDA will also verify that the device meets safety, performance, and labeling requirements as per Saudi regulations.

3. Request for Additional Information (if needed):

   • If the SFDA identifies any gaps or inconsistencies during the review process, they may request additional information or clarifications from the applicant.
   • This can lead to a delay of a few weeks depending on how quickly the applicant responds with the required documentation.

4. Final Decision and Approval (1-2 weeks):

   • Once the SFDA has reviewed all documents and is satisfied with the submission, they will issue a final decision.
   • If the device is approved, the SFDA will issue the Medical Device Registration Certificate.
   • The registration certificate is typically valid for 5 years, after which it must be renewed.

Review Process for A-Class Medical Device Registration with Saudi SFDA:

The review process for A-class devices is less rigorous than for higher-risk devices, but it still involves thorough scrutiny to ensure that the device is safe and effective for use in the Saudi market. Here’s what the review process includes:

1. Document Verification:

   • Completeness Check: The SFDA reviews whether all required documents (e.g., technical file, clinical data, risk management, labeling) are included and meet the requirements.
   • Verification of Certificates: The SFDA will verify certifications like CE marking (if applicable), ISO 13485 (Quality Management System), and Good Manufacturing Practice (GMP).

2. Compliance Check:

   • The SFDA will ensure the device complies with Saudi health and safety regulations and standards, such as:
     • Compliance with Saudi Standards Organization (SASO) requirements.
     • Compliance with GSO (Gulf Standardization Organization) standards if applicable.
     • Arabic language labeling and Instruction for Use (IFU) compliance.
   • Ensuring that the device is properly classified (as an A-class medical device) based on its risk profile.

3. Clinical Evaluation:

   • The SFDA may assess clinical data if the device claims medical efficacy. While A-class devices are typically lower-risk and may not require extensive clinical trials, any supporting clinical information (e.g., equivalence studies or previous clinical data) will be reviewed to ensure the device is safe and effective.

4. Risk Management:

   • For certain devices, especially those with potential risks to patients or healthcare workers, SFDA will evaluate the risk management process, including the risk analysis and mitigation strategies provided by the manufacturer, in line with ISO 14971.

5. Labeling and Packaging Review:

   • The labeling and packaging must be in compliance with SFDA regulations, including:
     • Arabic language labels, instructions, and warnings.
     • Country of origin, expiration date, and batch number details.
     • Device-specific information that aligns with Saudi requirements.

6. Verification of Manufacturing Processes:

   • The SFDA may require proof of Good Manufacturing Practices (GMP) or other certifications such as ISO 13485 to ensure that the device is being manufactured in a controlled and consistent environment that guarantees quality.

7. Post-Market Surveillance Plan:

   • The SFDA may also request information about the post-market surveillance and adverse event reporting systems in place, though A-class devices are generally less scrutinized than higher-class devices in this regard.

8. Authorization of Importer or Local Representative:

   • If applicable, the local authorized representative (if you are not based in Saudi Arabia) will also be reviewed. The local distributor must be registered and authorized to handle medical device imports and distribution in Saudi Arabia.

Delays and Additional Information

• Delays in Submission: If you submit incomplete or incorrect documentation, it may take longer for the SFDA to process your application.
• Additional Information Requests: If the SFDA requires clarification on any point or additional documents, it can delay the approval process by several weeks.
• SFDA Communication: Ensure that you are monitoring your email and the SFDA portal for any communication or requests from the authority, as any delay in responding can result in a longer processing time.

Summary of Estimated Timeframe for A-Class Medical Device Registration:

• Overall Processing Time: Generally takes between 4 to 12 weeks.
  • Initial review: 1-2 weeks.
  • Detailed review and evaluation: 2-6 weeks.
  • Response to additional information (if needed): Variable, depends on the response time.
  • Final decision and approval: 1-2 weeks.

This timeline can vary based on the completeness of your submission and any additional requests from SFDA for clarification or further documentation. Prompt responses to SFDA queries can help expedite the review process.

If you need further assistance or have specific questions about your device, feel free to ask!

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