Medical Devices Regulatory Services
in Saudi Arabia

Overview

Healthcare in Kingdom of Saudi Arabia (KSA) is recognized as a prime sector by government of the KSA, and there is a growing need for Medical Devices in the country. The Saudi Food and Drug Authority (SFDA), reporting to the Council of Ministers, regulates the Medical Devices in the KSA. Saudi Arabia Medical Device Regulations are influenced by cultural inclinations. In the country, linguistic barriers, rigorous scrutiny and less cooperation from the agency are the major bottlenecks to further proceed for device approval.

Regulatory Authority: Saudi Food & Drug Authority (SFDA)

Regulation: Interim Regulation Decree number 1-8-1429, 2008

Regulatory Pathway: MDNR Listing or MDMA Approval

Authorized Representative: Saudi Arabia Authorized Representative

QMS Requirement: ISO 13485:2016 certification

Assessment of Technical Data: Conformity Assessment Body (CAB)

Labeling Requirements: Article 18 of Interim Regulation

Submission Format: Electronic application @ MDMA

Language: English & Arabic

Saudi Arabia Medical Device Classification

In Saudi Arabia, Medical devices are classified into 4 classes. Grouping of models, variants, accessories into a single application is accepted as per the Saudi Arabia Medical Device Regulations. For border-line products and the devices which fall under different classes in the reference countries, there is a provision for Formal classification by SFDA.

Saudi Arabia Authorized Representative

All the foreign manufacturers without a legal entity or physical presence in the KSA are mandated to have Medical Device Authorized Representative (AR) to market the devices. The entity must have an AR license issued through the Medical Device Establishment (MDEL) System to act as an AR.

Saudi Arabia Medical Device Registration

Saudi Arabia Medical Device Registration Requirements vary with the class of the device. There are two medical device approval pathways in the country based on the class of device, such as:

• Medical Device National Registry (MDNR) Listing
  Class I Non-sterile/Non-Measuring Low Risk Medical Devices require listing in Medical Device National Registry (MDNR) as a pre-requisite for marketing the device in KSA. This can be carried out by any establishment importing or distributing the device in the KSA. This listing requires basic product and manufacturer information, proof of QMS, reference country approval, IFU, UDI, labeling, and marketing materials among other requirements. The SFDA timeline for medical device approval through this pathway is 4 working days and is valid for a period of 3 years.
• Medical Device Marketing Authorization (MDMA)`
  All other classes of devices must obtain medical device approvals issued as Medical Device Marketing Authorization (MDMA) to market the device in KSA. The SFDA Medical Device registration timeline for MDMA approval through this pathway is usually 35 days and the licenses are valid for a period of original license validity or 3 years for undefined original license validity.

   

Process flow

Post Approval Device Life Cycle Management

Freyr supports the foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as

• Post approval change management - modifications to existing medical device approvals such as, addition of new variants, accessories; addition of new indications of use among others
• Maintenance of approvals and registration through timely payment of administrative and registration fees
• Renewal of licenses
• Liaising between the SFDA and the manufacturer

Freyr with a network of affiliates spread across the globe and in the KSA navigates device manufacturers for full-scale device compliance. Freyr can act as Saudi Arabia Authorized Representative, support in SFDA medical device classification, carry out gap analysis of documents, compile device dossier, do the medical device submission, carry out Saudi Arabia Medical Device Registration, and provide linguistic support to deal with the SFDA.

Summary