What Does Class C Medical Device Registration in Saudi Arabia Mean?

In the context of Saudi Arabia, a Class C medical device is categorized under the Saudi Food and Drug Authority (SFDA) classification system, which is largely aligned with the IMDRF/GHTF framework.

🚦Class C: Definition

A Class C medical device is considered moderate-to-high risk. These devices:

• Usually support or sustain life

• Pose a moderate risk if malfunctioning

• Often are used in serious diagnostic or therapeutic procedures

Examples:

• Infusion pumps

• Diagnostic X-ray equipment

• Wound dressings with antimicrobial agents

• Bone fixation plates

🛡 SFDA Regulation Basis:

Saudi Arabia regulates medical devices through the SFDA’s Medical Devices Interim Regulation, which includes:

• Establishment Licensing

• Medical Device Marketing Authorization (MDMA)

• Post-market obligations

📝 What Does Registration Involve?

Registering a Class C medical device means:

1. Proving its safety and effectiveness

2. Demonstrating manufacturing quality (ISO 13485)

3. Complying with local (SFDA) and international (IMDRF) regulatory standards

4. Obtaining marketing authorization (MDMA license) to legally sell in the KSA market

✅ How to Apply for Class C Medical Device Registration in Saudi Arabia

Step 1: ✅ Appoint a Saudi Authorized Representative (AR)

If you are not based in Saudi Arabia, you must appoint a local AR:

• The AR acts as a regulatory liaison with SFDA

• Handles application submissions, vigilance, recalls

• Must hold a valid Establishment License (EL) from SFDA

Step 2: ✅ Register the Manufacturer and Importer Establishment

Both the manufacturer and distributor/importer/AR must be registered in SFDA’s GHAD system.

Document requirements for Establishment Licensing (EL):

• Valid commercial registration

• Quality management system certification (e.g., ISO 13485)

• Authorized person details

• AR contract or agreement

Step 3: ✅ Classify the Medical Device

Use SFDA’s Risk Classification Rules, based on IMDRF/GHTF guidance.

• You may optionally request a classification consultation from SFDA to confirm your product is Class C.

Step 4: ✅ Prepare and Submit the MDMA (Marketing Authorization) Application

Submit through the SFDA MDMA Portal with the following documentation:

Required Documents:

Portal:

• Use the MDMA e-service within SFDA’s GHAD system.

• Pay the application fee (~8,000–15,000 SAR depending on device complexity).

Step 5: ✅ SFDA Technical Review

• SFDA will assess:

  • Device classification

  • Conformity with safety and performance requirements

  • Labeling compliance

  • Manufacturing and clinical evidence

⏱ Typical Review Time: 3–6 months

Step 6: ✅ Receive the MDMA License

Once approved:

• You’ll receive a Medical Device Marketing Authorization Certificate

• This allows legal sale and distribution of the device in Saudi Arabia

🕒 Validity: Usually 3 years

Step 7: ✅ Post-Market Obligations

• Vigilance reporting (adverse events, recalls)

• PMS activities

• Renewal of MDMA before expiration

• Ongoing Arabic labeling compliance

• Possible local inspection or audit

📌 Summary: Application Process Flow

Contact Us：

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