Registering Class D medical devices in Saudi Arabia involves following the regulatory framework set by the Saudi Food and Drug Authority (SFDA), specifically under the Medical Devices Interim Regulation. Class D devices are the highest risk class in Saudi Arabia, so their registration is more stringent than lower classes.

Here’s a detailed step-by-step guide on how to register Class D medical devices in Saudi Arabia:

1. Understand the Classification

• Class D medical devices are those that pose the highest risk to patients/users, e.g., implantable devices, life-supporting devices.

• Confirm your device classification according to SFDA guidelines to ensure it is Class D.

2. Prepare Required Documentation

SFDA requires comprehensive documentation, including:

• Device Description & Specifications: Clear info on the device, intended use, variants.

• Technical Documentation: Including design, manufacturing process, risk management, clinical evaluation.

• Quality Management System: Certificate (e.g., ISO 13485).

• Declaration of Conformity: Confirming compliance with recognized standards.

• Clinical Evidence: Clinical evaluation reports and clinical investigation data if applicable.

• Labeling and Instructions for Use: In Arabic and English.

• Certificate of Free Sale or Market Authorization: From the country of origin or current market.

• Importer/Local Representative Details: Saudi authorized representative info.

3. Appoint a Saudi Authorized Representative (Local Authorized Representative - LAR)

• Foreign manufacturers must have a Saudi Authorized Representative responsible for registration and post-market obligations.

• The LAR must be registered with SFDA.

4. Register an Account on SFDA’s Medical Devices National Registry (MDNR)

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

• Create an account and submit a company profile.

• The Saudi Authorized Representative generally submits the application.

5. Submit Device Registration Application

• Fill out the device registration form via MDNR.

• Upload all required documents.

• Pay applicable fees (Class D devices usually have higher fees due to higher risk).

6. SFDA Review & Assessment

• SFDA conducts a technical and safety assessment of the dossier.

• They may request clarifications or additional information.

• For Class D devices, clinical evidence review is more stringent.

• SFDA may require an on-site audit of the manufacturer for Class D devices.

7. Product Testing and Inspection (if applicable)

• SFDA may request product testing reports or conduct inspections.

• Some Class D devices might require batch release testing.

8. Registration Approval and Issuance of Medical Device Marketing Authorization (MDMA)

• Upon successful review, SFDA issues the MDMA certificate.

• The device can then be legally marketed in Saudi Arabia.

9. Post-Market Surveillance Obligations

• Maintain compliance with SFDA post-market requirements.

• Report adverse events, product recalls, and safety issues.

• Keep documentation and registration details up to date.

Typical Timeline & Cost

• Timeline: Generally 6 to 12 months for Class D devices due to the complex review and possible on-site audits.

• Fees: Vary depending on device type, complexity, and classification; Class D has the highest fees.

Additional Tips

• Work with a local consultant or regulatory expert familiar with SFDA processes.

• Ensure all documents, especially labeling and instructions, comply with Saudi requirements (including Arabic language).

• Keep track of SFDA updates; regulations evolve.

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