Medical Devices Regulatory Support in Saudi Arabia

Overview

Healthcare in the Kingdom of Saudi Arabia (KSA) is recognized as a prime sector by the 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 medical devices in the KSA. Saudi Arabia’s medical device regulations are influenced by cultural inclinations. In the country, linguistic barriers and rigorous scrutiny are the major bottlenecks to further proceeding with device approval.

Saudi Arabia Medical Device Classification:

In Saudi Arabia, devices are classified into four (04) classes. The classification rules are in accordance with the Global Harmonization Task Force (GHTF) medical device classification. Grouping of models, variants, and accessories into a single application is accepted as per the Saudi Arabia medical device regulations.

Saudi Arabia Medical Device Registration:

The pathway toward the launch of a device in the Saudi Arabian market is a three (03) phased process as follows –

Step 1: Appointment of Medical Device Authorized Representative

• Foreign manufacturers shall appoint an Authorized Representative (AR).
• The AR shall have written procedures for the activities being carried out and shall have a Medical Device Establishment License (MDEL) in place to act as an AR.

Step 2: Saudi Arabia Medical Device Registration:

The devices must have reference country approvals to register devices in Saudi Arabia.

• Medical Device National Registry (MDNR) Listing: Class I non-sterile/non-measuring low-risk medical devices require listing in the MDNR as a prerequisite for marketing medical devices in the 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 Quality Management Systems (QMS), reference country approval, Instructions for Use (IFU), labeling, and marketing materials, among other requirements. The SFDA timeline for medical device approval through this pathway is four (04) working days and is valid for a period of three (03) 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 medical devices in the KSA. The SFDA medical device registration timeline for MDMA approval through this pathway is usually thirty-five (35) days, and the licenses are valid for a period of original license validity or three (03) years for the undefined original license validity.

Product Maintenance & Compliance

Freyr Expertise

• Regulatory Intelligence on Saudi Arabia Medical Device Registration
• End-to-end Saudi Arabia Medical Device Registration
• MDNR Listing and MDMA Approval
• Saudi Arabia Authorized Representation
• Query Support Management till Approval
• Artwork Management
• Labeling Management
• Translation Services
• Post-approval Change Management
• License Renewal and Transfer
• Customs Clearance