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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
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.
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 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:
Freyr supports the foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as
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.
Device Class | Approval Routes | Timelines | Validity |
Class I |
MDNR Listing |
1 Month |
3 years |
Class II |
MDMA Approval |
6 Months |
Depends on validity of Original License |
Class III |
MDMA Approval |
9 - 24 Months |
Depends on validity of Original License
|
Class IV |
MDMA Approval |
9 - 24 Months |
Depends on validity of Original License
|
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