The purpose of obtaining Class C medical device registration in Saudi Arabia is to ensure that medium-to-high risk medical devices entering the Saudi market meet the country’s regulatory requirements for safety, effectiveness, and quality before being marketed, sold, or used.

Key Purposes of Class C Medical Device Registration:

1. Ensure Patient Safety and Public Health Protection

• Class C devices pose a moderate to high risk to patients or users.

• Registration guarantees that these devices have undergone rigorous assessment to minimize risks.

• Helps prevent unsafe or ineffective devices from reaching healthcare providers and patients.

2. Legal Authorization for Market Access

• SFDA registration provides the legal marketing authorization (MDMA certificate) required to import, distribute, and sell Class C devices in Saudi Arabia.

• Without registration, medical devices cannot be legally placed on the Saudi market.

3. Regulatory Compliance

• Demonstrates that the manufacturer complies with SFDA’s regulations and standards, including:

  • Technical requirements (design, manufacturing, clinical evidence)

  • Quality management system (ISO 13485)

  • Risk management (ISO 14971)

  • Labeling and instructions in Arabic and English

4. Facilitate Market Surveillance and Traceability

• Registered devices are tracked by SFDA for post-market surveillance.

• Enables SFDA to monitor adverse events, recalls, and maintain device safety in the market.

5. Build Trust and Credibility

• Registration signals to healthcare providers, distributors, and patients that the device meets recognized safety and performance standards.

• Supports market acceptance and competitive positioning.

If you want, I can provide more detail on how registration benefits manufacturers or healthcare stakeholders in Saudi Arabia!

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