The timeline for D-class medical device SFDA registration in Saudi Arabia can vary depending on the complexity of the device and the completeness of the application. However, the general process typically follows these steps:

Estimated Timeline for D-Class Medical Device SFDA Registration

Step 1: Preliminary Preparations

• Time: 1 to 2 months
  • Appoint an Authorized Representative (if applicable).
  • Prepare Required Documents (clinical data, risk management file, labeling, performance data, manufacturing certification, etc.).
  • Ensure compliance with international standards (e.g., ISO 13485, ISO 14971, IEC 60601, etc.).
  • Verify device classification as D-class and ensure you meet all regulatory requirements.

Step 2: Registration on SFDA’s Unified Electronic System (SUES)

• Time: 1 to 2 weeks
  • Create an account on the SFDA’s Unified Electronic System (SUES) if you do not already have one.
  • Submit basic company information and register as a manufacturer or authorized representative.
  • Once registered, log into the Medical Device Marketing Authorization (MDMA) system to submit the application.

Step 3: Application Submission

• Time: 1 to 2 weeks
  • Complete the MDMA application form on the SUES portal.
  • Upload all required documentation, including the risk management file, clinical evaluation reports, performance testing, manufacturing site certification, and labeling (in both Arabic and English).
  • Pay the applicable registration fees through the SUES portal.

Step 4: SFDA Review Process

• Time: 3 to 6 months (or longer)
  • Administrative Review (1 to 2 weeks): SFDA verifies the completeness and accuracy of the application.
  • Technical Review (2 to 4 months): SFDA evaluates the technical data, including clinical evidence, risk management, and compliance with international standards. They may request additional information or clarification.
  • Manufacturing Site Inspection (if applicable): For devices manufactured outside of Saudi Arabia, SFDA may request an inspection of the manufacturing facility to ensure it complies with Good Manufacturing Practices (GMP).
  During this phase, the SFDA may request further documentation, which can extend the timeline if responses are delayed.

Step 5: Response to Queries (if applicable)

• Time: 1 to 2 months (depending on the complexity and responsiveness)
  • If SFDA requests additional information, manufacturers must provide a detailed response. Any delays in submitting the requested documents or clarifications could add additional time to the overall process.

Step 6: Approval and Issuance of Registration Certificate

• Time: 1 to 2 weeks
  • After successfully passing the review, SFDA will approve the registration and issue a Registration Certificate.
  • The device can now be legally marketed in Saudi Arabia.
  • Registration validity: Typically, the registration certificate is valid for one year, after which the device must be renewed annually.

Step 7: Post-Market Surveillance (Ongoing)

• Time: Ongoing
  • Adverse event reporting and Post-market Surveillance (PMS) are ongoing requirements.
  • Manufacturers must report any incidents, issues, or recalls related to the device to SFDA within the specified time frame.

Total Estimated Timeline

• Total Time for Registration: 6 to 12 months (on average)

The timeline can vary significantly depending on several factors:

• The complexity of the device and its associated risks.
• The completeness and accuracy of the submitted documentation.
• SFDA’s workload at the time of submission.
• Whether an inspection of the manufacturing site is required (which may add additional time).
• The responsiveness of the applicant to any requests for further documentation.

Summary of Key Milestones

1. Preparation of Documents: 1 to 2 months
2. Account Creation on SFDA SUES: 1 to 2 weeks
3. Application Submission: 1 to 2 weeks
4. SFDA Review (Administrative + Technical): 3 to 6 months
5. Response to Queries: 1 to 2 months (if required)
6. Approval and Registration Issuance: 1 to 2 weeks
7. Post-Market Surveillance: Ongoing

By ensuring that all required documentation is complete and accurate, you can potentially avoid delays and ensure a smoother and quicker registration process for your D-class medical device.

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