Overview

Healthcare in Kingdom of Saudi Arabia (KSA) is recognized as a prime sector by government of KSA, and there is a growing need for Medical Devices in the country. Saudi Food and Drug Authority regulates the Medical Devices in Saudi, reporting to the Council of Ministers. But Saudi has special regulations in place influenced by cultural inclinations. The classification is broader than most others, with sub-classes (Class I, IIa, IIb, and III). Linguistic barriers, rigorous scrutiny and less cooperation from the agency are the major bottlenecks to further proceed for device approval.

Freyr navigates device manufacturers for full-scale device compliance. Freyr assists in appointing Saudi Authorized Representative, document compilation and provides linguistic support to deal with the agency. Freyr also liaises with the SFDA to expedite the approval process.

 

Saudi Arabia Market Entry for Medical Devices - Process Flow

Saudi Arabia Medical Device Regulations

 

 

Freyr Expertise

  • Medical Device Classification
  • Saudi Authorized Agent Representation
  • Dossier/Document Compilation
  • Post-Market Surveillance

 

Summary

S.No

Regulatory Parameter

KSA

1

Regulatory Authority

Saudi Food & Drug Administration (SFDA)

2

Regulation

Interim Regulation Decree number
1-8-1429, 2008

3


Risk Classification
(As per GHTF reference country)

Class I

Class I

Class IIa

Class II

Class IIb

Class III

Class III

Class IV

4

Regulatory Pathway

Marketing Authorization

5

Authorized Representative

Saudi authorized representative is required

6

Fee payable

Administrative Fees

$300*

 

 

Reduced Fees

$1,350*

7

QMS Requirement

ISO 13485

8

Assessment of Technical Data

Conformity Assessment Body (CAB)

9

Validity of License

Class I

3 years

 

 

Rest

Depends on CE Mark

10

Labelling Requirements

Article 18 of Interim Regulation

11

Submission format

Electronic application @ MDMA

12

Final Outcome

Marketing Authorization

13

Timelines

1 - 2 Months

14

Language

English & Arabic

*The price is as per records at the time of documentation and is subject to change.