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KSA Update: New Guidance on Saudi Medical Device Classification and More

The Kingdom of Saudi Arabia (KSA) has introduced new guidance on medical device classification as well as other updates.

New Saudi medical device regulation

January 17, 2023

The Kingdom of Saudi Arabia (KSA) has introduced new guidance on medical device classification. In addition, KSA issued an announcement on the handling of low-risk medical devices in the Medical Device National Registry (MDNR). In other news, guidelines were released for the use of radiation-emitting medical devices. Also, updated guidance for clinical trials of medical devices was published. Finally, the Saudi Food and Drug Authority (SFDA) published English versions of recognized standards for certain medical devices and quality management system (QMS) requirements.

SFDA updates guidance on medical device classification

​​The SFDA has issued MDS-G008, Guidance on Medical Devices Classification, which replaces MDS-G42 and is based on the Medical Devices Law.

The classification rules for medical devices and IVDs remain unchanged. However, the description and examples for some rules have been modified to further clarify the interpretation of the classification rules. For example, dressings for nose bleeds (previously covered by Rule 5 as an invasive device) are now covered by Rule 4 as a device that comes into contact with injured skin or mucous membrane. Other devices such as infusion cannulas had their risk classification reduced from Class C to Class B, according to the guidance.

In addition, MDS-G008 significantly expands the set of examples for each classification rule of IVDs.

Announcement on the handling of low-risk medical devices in the MDNR

​​The SFDA has released a circular highlighting the deadline for applying for the simplified device listing route for Class A medical devices (low-risk, non-measuring, non-sterile) via the MDNR.

According to Announcement (MDS-CIR-001-V1/220324) (link in Arabic), the deadline for submitting new/renewal applications under the MDNR was on September 27, 2022. Since the deadline has already passed, all Class A medical devices that do not have a valid registration shall be removed from the KSA market.

Guidelines for the use of radiation-emitting medical devices

​The SFDA has issued MDS-G007, Guidelines for the Operation and Use of Radiation-Emitting Medical Devices, (link in Arabic) which provides guidelines for implementing a radiation protection program for health facilities that use medical devices with radioactive sources or materials. The guide should be used in conjunction with MDS-REQ 1 and MDS-REQ 3 with regard to the basic requirements of medical devices and facilities. It also replaces other guidance documents related to radiation protection programs, bone densitometry devices, mammography equipment, and others listed in Annex 2 of MDS-G007.

Notably, the guide provides instructions for limiting the radiation exposure of patients and health workers, especially those who are pregnant. The medical device must comply with the inspection and preventive maintenance requirements of the SFDA, which include creating policies for dealing with safety alarms and corrective actions for safety alarms, labeling, and calibrating the device and the test equipment.

In addition, it also provides requirements for the user of the device, the device room, and for conducting risk assessments on exposure limits and the condition of patients.

Updated guidance for clinical trials of medical devices

​The SFDA has issued version 4.1 of MDS-REQ 2, Requirements for Clinical Trials of Medical Devices, which updates the terms and references in the document to align with the Medical Device Law and its executive regulations.

Notably, the guidance MDS-G31 was replaced by MDS-REQ 11 with regard to reporting and investigating serious adverse events or device deficiencies related to the clinical trial.

SFDA publishes English versions of recognized standards for certain medical devices

​​The SFDA has published updated English versions of the following guidance documents:

There are no notable changes observed in the guidance documents.

In addition, an English version of the guidance on QMS requirements was also published.

Emergo by UL will post updates to the guidance as they become available.