The eligibility criteria to apply for Class C medical device registration in Saudi Arabia are established by the Saudi Food and Drug Authority (SFDA) to ensure that only qualified manufacturers or authorized representatives can submit registration applications. These criteria help maintain device safety, quality, and regulatory compliance.

Here’s a detailed breakdown of the key eligibility requirements:

✅ 1. Applicant Eligibility

🔹 Manufacturers

• Must be a legally established company with proper commercial registration in their country.

• Required to have a valid ISO 13485 certification issued by an accredited certification body for medical devices.

• Must maintain a quality management system (QMS) consistent with SFDA requirements.

• Responsible for preparing and maintaining the technical documentation required by SFDA.

• If located outside Saudi Arabia, must appoint a Saudi Authorized Representative (AR) to act on their behalf.

🔹 Authorized Representative (AR)

• Must be a legal entity registered in Saudi Arabia.

• Must hold a valid Establishment License (EL) issued by SFDA.

• Responsible for:

  • Submitting applications to SFDA

  • Communicating with SFDA during review

  • Handling post-market obligations (e.g., adverse event reporting, recalls)

• Must have a formal Legal Representation Agreement (LRA) with the manufacturer.

• AR must have a physical presence (office) in Saudi Arabia.

✅ 2. Device Eligibility

🔹 Class C Device Classification

• The device must be properly classified as Class C according to SFDA’s Medical Device Classification Rules.

• Devices with moderate-to-high risk profiles—such as infusion pumps, diagnostic imaging equipment, and electrosurgical devices—fall under Class C.

• Devices must not fall under higher risk Class D or lower risk Class A/B categories.

✅ 3. Documentation and Compliance Eligibility

• The applicant must provide a complete technical file including:

  • ISO 13485 certificate

  • Risk management report (ISO 14971)

  • Clinical evaluation report (CER)

  • Declaration of conformity

  • Labeling and Instructions for Use (IFU) in Arabic and English

  • Certificate of Free Sale (FSC) or equivalent proof of market authorization in the country of origin

• Device labeling and IFU must include Arabic language.

• The device must comply with SFDA Essential Principles for safety and performance.

• If the device has prior approvals (CE mark, FDA clearance, TGA, etc.), this facilitates eligibility via abridged review.

✅ 4. Establishment License (EL) Eligibility

• Both the manufacturer (or their foreign entity) and the Saudi AR must obtain an Establishment License from SFDA before applying.

• EL applicants must provide:

  • Commercial registration documents

  • Organizational chart

  • QMS certification

  • List of medical devices to be marketed

✅ 5. Financial and Ethical Eligibility

• Applicants must be in good financial standing with SFDA (no outstanding fees or penalties).

• Must comply with SFDA’s ethical standards and regulatory guidelines.

• No history of regulatory violations or fraud related to medical devices.

✅ Summary Table of Eligibility Criteria

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