Saudi Arabia Medical Device Registration

An Overview of Medical Device Regulations and Requirements in Saudi Arabia

Regulatory Authority

Saudi Food & Drug Authority (SFDA) oversees the regulation of medical devices.

The Saudi Food & Drug Authority (SFDA) regulates food, drugs, and medical devices in Saudi Arabia, ensuring public safety and quality standards. For medical devices, SFDA oversees classification, registration, technical documentation, labeling, and post-market surveillance. Its stringent requirements ensure compliance with global standards.

Manufacturers seeking to market their devices in Saudi Arabia must adhere to SFDA’s regulatory framework, including obtaining Medical Device Marketing Authorization (MDMA). SFDA plays a pivotal role in enhancing healthcare quality and patient safety.

Link for Regulatory Authority

https://www.sfda.gov.sa/en

Medical Device Classification

Local Listing or Registration

1. Determine the device classification.
2. Appoint an Authorized Representative for Medical Devices in Saudi Arabia.
3. Prepare the application form and required documentation.
4. Submit the information for registration purposes
5. Provide the medical device listing information to the Medical Device National Registry (MDNR)
6. Submit Medical Device Marketing Authorization (MDMA)
7. Once approved, the device can be marketed.

Documents Required for Saudi Medical Device Registration

• Registration application with the company’s stamp.
• Authorized Representative
• MDNR Listing
• Technical File
• Conformity Assessment Report
• Medical Device Market Authorization Certificate
• Post-Market Surveillance Plan

Language Requirements

Documentation and Labeling can be provided in Arabic.

Registration Timeline

• Initial Submission Review: Initial submissions are usually reviewed by the SFDA in 30 to 60 days.
• Technical Documentation Review: Depending on the device’s complexity, a thorough examination of the technical documentation may need an extra 60 to 120 days.
• Approval and Issuance of MDMA: Between three and six months may pass between submission and MDMA issuing.

License Validity

3 Years

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication? 

Before placing a medical device into Saudi Arabian market.

Why Choose OMC Medical?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk

Frequently Asked Questions: Saudi Arabia Medical Device Registration

1. What is the process for registering a medical device in Saudi Arabia?

To register a medical device, you must follow SFDA guidelines, submit technical documentation, classify your device, and obtain SFDA medical device approval through their portal.

2. How long does the medical device registration process take in Saudi Arabia?

The timeline varies depending on the device class and completeness of submitted documents but typically ranges from 3 to 6 months.

3. Do I need a local authorized representative for SFDA registration?

Yes, a local authorized representative in Saudi Arabia is required to manage communication with the SFDA and facilitate the registration process.

4. What are the requirements for medical device labeling in Saudi Arabia?

Labels must comply with SFDA standards, including Arabic translations, proper device identification, and manufacturer details.

5. Can foreign manufacturers register medical devices directly with the SFDA?

No, foreign manufacturers must work through a Saudi-based authorized representative to register their devices with the SFDA.