To register an A-class medical device with the Saudi Food and Drug Authority (SFDA), you must follow a structured process through the SFDA e-Portal (also known as MDRS – Medical Device Registration System). Below is a detailed, step-by-step guide to the registration process:

Step 1: Prepare the Required Documents

Before starting the application process, you need to gather the required documents and ensure they comply with SFDA guidelines. The key documents typically required for A-class medical devices include:

1. Application Form:

   • Complete the SFDA Medical Device Registration Application Form, available on the SFDA portal.

2. Device Information:

   • Device description (intended use, function, and purpose).
   • Risk classification (A-class).
   • Manufacturer’s details (name, address, and contact information).

3. Certificates and Quality Assurance Documents:

   • Good Manufacturing Practices (GMP) certificate or evidence of ISO 13485 certification.
   • CE Marking (if applicable).
   • Certificate of Free Sale (if the device is already sold in another market).

4. Clinical Evaluation:

   • Clinical data or performance testing results (if applicable).

5. Risk Management:

   • Risk assessment and risk management documentation (e.g., compliance with ISO 14971).

6. Labeling Information:

   • Product labels and Instructions for Use (IFU) in Arabic (if applicable).
   • Warnings and safety instructions in compliance with SFDA guidelines.

7. Test Reports:

   • Safety and performance testing reports, including biocompatibility, electrical safety, etc.

8. Local Authorized Representative (if the manufacturer is outside Saudi Arabia):

   • Details of the authorized representative or distributor in Saudi Arabia.

Step 2: Register on the SFDA e-Portal

To start the application process:

1. Create an Account:

   • Go to the SFDA e-Portal (MDRS) website.
   • If you do not have an account, create one by registering as a manufacturer or a local authorized representative (if applicable).

2. Log in:

   • Use your credentials to log into the MDRS system.

Step 3: Submit the Application

Once logged in:

1. Select Application Type:

   • Choose the A-class medical device category during the application process.

2. Complete the Application Form:

   • Fill in the Medical Device Registration Form with all required information, including:
     • Device details.
     • Manufacturer information.
     • Risk classification.

3. Upload Documents:

   • Upload all the required documents, including:
     • Certificates (CE, GMP, ISO, etc.).
     • Clinical data (if applicable).
     • Test reports and safety documentation.
     • Labeling and packaging information (including Arabic labeling if necessary).

4. Payment of Fees:

   • Pay the registration fee via the SFDA portal. The amount will be shown during the submission process.

Step 4: SFDA Review and Evaluation

After the application is submitted, the SFDA will review the documents and evaluate the device. The review process includes:

1. Document Verification:

   • Verification of the completeness and correctness of the submitted documents.

2. Technical Evaluation:

   • The SFDA assesses whether the device meets the regulatory requirements and is classified correctly (as A-class).
   • Compliance with ISO 13485 (Quality Management System) and ISO 14971 (Risk Management) will be checked.

3. Labeling Compliance:

   • The SFDA ensures that the device’s labeling, including instructions for use (IFU), is compliant with Saudi regulations, especially with regard to Arabic language requirements.

4. Additional Information:

   • If necessary, the SFDA may request additional documentation or clarifications. Be prepared to respond promptly to avoid delays.

Step 5: SFDA Decision and Registration Certificate

Once the SFDA completes its review, they will issue a decision:

1. Approval:

   • If the device meets all regulatory requirements, the SFDA will issue the Medical Device Registration Certificate. This certificate is typically valid for 5 years.

2. Denial:

   • If there are issues with the application, the SFDA may issue a denial notice. In this case, the reasons for denial will be provided, and you may need to address the issues and reapply.

Step 6: Post-Registration Requirements

After obtaining registration, there are certain ongoing obligations:

1. Adverse Event Reporting:

   • You must report any adverse events or malfunctions related to the device to the SFDA.

2. Post-Market Surveillance:

   • You may need to conduct post-market surveillance and submit any required safety update reports or other information.

3. Renewal:

   • The registration is valid for 5 years, and you will need to renew it before it expires. SFDA will provide instructions on how to renew your registration.

Summary of the Steps to Register an A-Class Medical Device with SFDA:

1. Prepare the required documents (device details, certificates, clinical data, risk management).
2. Register on the SFDA e-Portal and create an account.
3. Fill out the registration application form and upload required documents.
4. Pay the registration fee.
5. SFDA review of the submitted documents, including technical evaluation and labeling compliance.
6. SFDA decision (approval or denial).
7. Receive the Medical Device Registration Certificate upon approval.
8. Post-registration requirements (adverse event reporting, post-market surveillance, renewal).

The overall process for A-class medical device registration with the SFDA can take approximately 4 to 12 weeks, depending on the completeness of your application and any requests for additional information.

If you have further questions or need assistance at any stage, feel free to ask!

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