To submit the application for Class D medical device registration in Saudi Arabia, you must follow the official procedure via the Saudi Food and Drug Authority’s (SFDA) Medical Devices National Registry (MDNR) portal. Here’s a clear step-by-step guide to help you through the submission process:

Step-by-Step Guide to Submit Class D Medical Device Registration Application

1. Prepare Your Documents

Ensure you have all required documents ready in digital format (usually PDF), including:

• Technical dossier (device description, risk management, clinical data, verification & validation reports, labeling/IFU, etc.)

• Certificates (ISO 13485, Establishment License for manufacturer and Local Authorized Representative)

• Regulatory approvals from other countries (CE, FDA, etc.)

• Declaration of Conformity

• Local Authorized Representative (LAR) authorization letter

• Commercial Registration (CR) certificates

2. Create or Access Your Account on MDNR Portal

• Visit the SFDA MDNR portal: https://mdnr.sfda.gov.sa

• Log in with your credentials; if you do not have an account, register as the Local Authorized Representative (LAR).

3. Initiate a New Registration Application

• After login, select the option to “Submit New Medical Device Registration.”

• Choose Class D as the device classification.

4. Fill in the Application Form

• Provide detailed product information:

  • Device name, model, and intended use

  • Manufacturer details

  • LAR details

  • Device classification justification

  • Applicable standards and certificates

5. Upload Required Documents

• Upload all required documents in the specified sections.

• Ensure documents are clear, correctly named, and formatted per SFDA guidelines.

• Double-check for bilingual (Arabic and English) labels and IFUs.

6. Review and Confirm Submission

• Carefully review all entered information and uploaded files.

• Confirm that all mandatory fields are completed.

• Submit the application.

7. Pay Registration Fees

• Upon submission, you will be prompted to pay the applicable registration fees.

• Payment can usually be made via electronic banking or SFDA’s payment gateway integrated into the portal.

8. Track Application Status

• Use the MDNR portal dashboard to monitor the status of your application.

• Respond promptly if SFDA requests additional information or documents.

Tips for Successful Submission:

• Prepare your documents in advance to avoid delays.

• Keep all files organized with clear file names.

• Use the portal’s help or FAQ sections if unsure about any step.

• Maintain clear communication with your LAR if you are a foreign manufacturer.

Contact Us：

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