Class D medical device registration in Saudi Arabia refers to the regulatory process required to legally import, distribute, and sell high-risk medical devices in the Kingdom, under the oversight of the Saudi Food and Drug Authority (SFDA).

Class D is the highest risk category, typically including devices that:

• Sustain or support life

• Are implanted in the human body

• Present a high potential for serious harm if they fail

Examples: implantable pacemakers, cardiac stents, ventilators, bone fixation plates, etc.

🔍 What is Class D Medical Device Registration?

It is the official procedure by which a Class D medical device is reviewed, approved, and granted a Medical Device Marketing Authorization (MDMA) by the SFDA. This authorization is mandatory for importing and distributing the device within Saudi Arabia.

The SFDA's regulatory framework is aligned with the International Medical Device Regulators Forum (IMDRF) and is based on a risk-based classification system (A–D).

📝 How to Apply for Class D Medical Device Registration in Saudi Arabia

✅ Step-by-Step Application Process

Step 1: Determine the Device Classification

• Use the SFDA Medical Device Classification Guidelines.

• Confirm that your product falls under Class D, the highest risk category.

Step 2: Appoint a Local Authorized Representative (LAR)

• If the manufacturer is not based in Saudi Arabia, they must appoint a Local Authorized Representative (LAR).

• The LAR acts on behalf of the manufacturer in regulatory submissions and compliance matters.

💡 Only Saudi-licensed companies can act as LARs. They must also be registered in the SFDA's Establishment Licensing portal.

Step 3: Establishment Licensing (EL)

• Before registering the product, both the manufacturer and LAR must obtain an Establishment License via the SFDA’s GHAD platform.

• Required documents:

  • Business license

  • Quality Management System (QMS) certificate (ISO 13485)

  • LAR agreement

  • Trade registration certificate

Step 4: Prepare the Technical Documentation

Your Class D registration must include:

• Device Description & Intended Use

• Technical File (Design dossier or Summary Technical Documentation)

• QMS certificate (ISO 13485)

• Clinical Evaluation Reports

• Risk Management File

• Instructions for Use (IFU) and product labels (in Arabic & English)

• CE Certificate or other approvals (e.g., FDA 510(k), MHLW, TGA)

• Market History (countries where marketed)

• Declaration of Conformity

• Certificate of Free Sale

Step 5: Register the Device in the Medical Devices National Registry (MDNR)

• Submit the application through SFDA’s MDNR Portal: https://mdnr.sfda.gov.sa

• Create a user account and complete the online form.

• Upload all necessary documentation.

Step 6: Pay SFDA Fees

• SFDA charges a review and registration fee.

• Fees are higher for Class D due to the complexity of review.

• Payment is made via the SFDA’s SADAD system.

Step 7: SFDA Review and Assessment

• SFDA performs:

  • Administrative review: checks completeness of documents

  • Technical review: assesses product safety, effectiveness, and performance

  • Clinical review: in-depth review of clinical evidence (especially for implants or new tech)

  • QMS review: may require audit for Class D if manufacturer lacks recent inspection reports

⏳ Timeframe: Review can take 6 to 12 months, depending on complexity and responsiveness.

Step 8: Receive MDMA (Marketing Authorization Certificate)

• If approved, SFDA issues the Medical Device Marketing Authorization (MDMA) certificate.

• The MDMA number must appear on shipping/import documentation and labels.

Step 9: Post-Market Obligations

• Report adverse events and incidents.

• Comply with SFDA recalls and safety notice procedures.

• Renew MDMA regularly (every 3–5 years, depending on device type).

• Monitor field safety corrections.

📦 Additional Requirements for Importation

Once registered:

• The device can be imported via Saudi customs using the MDMA certificate.

• Importers must also be licensed and listed under the Saudi Product Safety Program (SABER).

📄 Summary Table

✅ Pro Tips

• Use an experienced LAR or local consultant who is familiar with SFDA Class D protocols.

• Ensure all IFU, labels, and documentation are bilingual (English + Arabic).

• Submit well-organized documentation to reduce SFDA queries and delays.

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