The Regulation of Medical devices & Medical Supplies
The Council of Ministers approved the Medical Devices and Medical Supplies Regulations on
06/07/1442 H, 02/18/2021
The regulation come into effect after 180 days from publication in the Official Newspaper.
What is the Regulation of Medical Devices & Medical Supplies?
A regulatory system for medical devices and medical supplies in the Kingdom of Saudi Arabia that includes regulations, legislative, and supervisory materials that cover the life cycle of the medical device from concept, innovation, design, technical standards, quality systems, clinical studies, and even a post-marketing follow-up and monitoring phase in order to ensure the safety, and efficacy of medical devices and medical supplies.
The Objectives of this Regulation
Protecting public health in the Kingdom of Saudi Arabia by implementing procedures and requirements that ensure the safety and protection of the patients’ health and users of medical devices and medical supplies.
Take the necessary procedures and determine the necessary responsibilities to ensure that the medical devices and medical supplies in the Kingdom of Saudi Arabia comply with the SFDA regulations.
Strengthening the kingdom’s international leadership role in the field of medical devices and medical supplies.
Supporting investments by having an internationally harmonized system that contributes to encouraging manufacturers and large companies to invest and open subsidiary manufacturing sites in the Kingdom of Saudi Arabia.
An effective economic impact on the Saudi market by creating a harmonized environment with international regulations for international medical devices and medical supplies.
Supporting innovation and technological development for medical devices and medical supplies.
The most prominent materials of this Regulation
01 | Medical devices and medical supplies are not allowed to be traded in the Saudi Market before registration to gain Marketing Authorization after ensuring its safety.
03 | Establishments wishing to trade its products in the Saudi market must adhere to implementing the quality management system.
05 | Imported medical devices and medical supplies cannot get a custom clearance without the approval from the Saudi Food & Drug Authority (SFDA).
07 | It is not allowed to re-use or re-cycle single use medical devices.
09 | The approval from the Saudi Food & Drug Authority is required for the technical and clinical specifications of radioactive medicinal items before licensing them.
02 | Health care providers are obligated to report accidents related medical devices and medical supplies to the Saudi Food & Drug Authority through the National Center for Medical Devices Reporting.
04 | Medical devices for personal use allowed to be imported in limited quantities.
06 | The manufacturer must provide after-sales services for its medical devices and medical supplies.
08 | It is not allowed to advertise or promote medical devices and medical supplies without the approval from the Saudi Food & Drug Authority (SFDA).
10 | The Saudi Food& Drug Authority may exclude innovative medical devices and medical supplies from some of the necessary requirements to obtain Marketing Authorization, in a manner that does not affect its safety while in use.
Source: Saudi Food & Drug Authority.