Chapter 1 Saudi Arabian SFDA administration information abstract

1. Administration and Abstract

The administration in Saudi Arabia is the Saudi Food & Drug Authority (SFDA). Its main responsibilities are to regulate, supervise and monitor food, drugs, medical devices, cosmetics, feed, tobacco, pesticides, and to develop its mandatory standard specifications, whether they are imported or locally produced.

2. Administrative Regulation

[Medical Devices Law]

[Implementing Regulation of Medical Devices Law]

3. Risk Level Classification of Medical Device and IVD Products

Saudi Arabia divides medical device MD and in vitro diagnostic reagent IVD into categories A, B, C and D according to the risk level of medical devices from low to high.

According to the risk level of medical devices from low to high, in vitro diagnostic reagents IVD is divided into: 

4. Entry requirements

Product lists, design descriptions, accessories, materials, drawings, packaging, photos, risk analysis and other reports, as well as certificates, plans, test reports, clinical evaluations, checklists, statements, etc., cover many aspects from product information to various certification and evaluation requirements to ensure that medical devices comply with relevant standards and regulations to ensure their safe and effective marketing and use.

CE is not mandatory in Saudi Arabia, but if there is a CE mark on the product label, it is necessary to submit evidence to support it.

5. Registration Language

English. If the medical device is intended for home use or non-professional use, Arabic translations of the label, instructions for use, and marketing materials are required

6. Authorized representative of Saudi Arabia

Authorized representative (AR) means any natural or legal person established within the Saudi KSA and authorized in writing by the manufacturer to perform specific tasks on its behalf, including the obligation to communicate with SFDA on behalf of the manufacturer.

Responsibilities:

①Must have AR business license MDEL in Saudi Arabia, if authorized to represent multiple manufacturers, need to apply for a separate business license for different manufacturers. SFDA should be informed of any updates from MDEL. AR business license MDEL is valid for 1 year. Applicants may apply for renewal of AR business license within 60 days prior to expiration.

②A written authorization is required which sets out the designated duties of the authorized representative. Establish and comply with procedures and SOP for authorized activities to meet the requirements of the quality management system.

③The manufacturer can choose to appoint one authorized representative to represent all medical devices, or to appoint a different authorized representative for each device class.

Chapter 2 Registration Flow、Cycle & Official Fee

1. Registration Flow 

2. Cycle & Official Fee

Registration cycle: MDMA approval duration is 2-3 months after submission of application materials, higher risk level products approval duration will be longer.

Official Fees:

AR annual fee: 1840USD

Evaluation fee for Class A registration: SAR 15000

Evaluation fee for Class B registration: SAR 19,000

Evaluation fee for Class C registration: SAR 21000

Evaluation fee for Class D registration: SAR 24,000

Chapter 3 FAQ

Q: What is a License to Operate (LTO)? Is the customs clearance document (Declaration of conformity) the same as the registration document?

A: The customs clearance document is different from the "declaration that the goods comply with medical device and product control regulations", which refers to the registration and licensing information of the products in the goods, as well as the documentation of the manufacturer confirming that the products are shipped by the importer.

Q: What does a post-market evaluation study mean?

A: These are studies conducted on medical devices using scientific methods to verify their safety/effectiveness because of the presence of safety signals on the devices sold locally.

Q: What are the expected outcomes of the post-market evaluation study?

A: Corrective action；Preventive measure；Additional clinical studies are required to provide evidence of the safety and effectiveness of medical devices；Disseminate secure communications to users and healthcare providers.

Q: If a manufacturer sells a medical device directly to a buyer without an authorized representative (AR), who is responsible for notifying the affected buyer and providing a corrective action plan and closure?

A: Manufacturers are responsible for medical devices sold in Saudi Arabia, as well as suppliers and distributors.

Q: What procedures are followed for appointing a manufacturer liaison officer or his authorized representative to SFDA?

A: You must comply with the Medical Device Post Marketing Supervision Person Notice, sign the authorization agreement and submit it to SFDA to obtain the ARL (Authorized Representative License).

ARL require Apostille.