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 medical device regulations are influenced by cultural inclinations. In the country, linguistic barriers and rigorous scrutiny are the major bottlenecks to further proceed for 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 GHTF Medical Device Classification. Grouping of models, variants, accessories into a single application is accepted as per the Saudi Arabia medical device regulations.

Saudi Arabia Medical Device Classification

Medical Devices

Device Risk

Class I

Low Risk

Class II

Low - Medium Risk

Class III

Medium - High Risk

Class IV

High Risk


Saudi Arabia Medical Device Registration:

The pathway towards launch of a device in Saudi Arabian market is a three (03) phased process -

Step 1: Appointment of Medical Device Authorized Representative

  • Foreign manufacturers shall appoint an Authorized Representative (AR).
  • The Authorised Representative (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 device in Saudi Arabia.

  • 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 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 QMS, reference country approval, 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 35 days and the licenses are valid for a period of original license validity or three (03) years for undefined original license validity.

Product Maintenance & Compliance

Sr. No

Application

Validity

01

MDNR Listing for Class I devices

Three (03) years

02

Medical Device License for other class devices

Three (03) years


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
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