The SFDA revealed its new regulation which aims to precisely control medical devices, and insures that it will license the importing companies after 60 days. According to the Executive Vice President of the SFDA Medical Devices Sector Dr. Saleh Attayar, nine land borders have been designated to import medical devices to the Kingdom and supported with employees from the SFDA to insure safety and conformity of these devices to medical and technical provisions of the regulation. Dr. Attayar stated in a press conference in the SFDA headquarter in Riyadh:" We will start registering and licensing establishments after two months as a first process, secondly, we will permit and market medical devices". He added too:" We will control medical devices thoroughly and work on safety of patients, citizens and users of these medical devices". Moreover, he confirmed that the SFDA set provisions to store and transport devices in a way that suits the Kingdom environment and it formed inspection teams to monitor the importing companies and insure their commitment to provisions.

Dr. Attayar stated that we will apply the concept of partnership in dealing with companies, and we will give them opportunity to be renovated to meet the SFDA requirements; as the SFDA has a support department in which employees dedicate themselves to take care of companies, and we look forward to develop importers levels to reach international ones. He added too that devices should have the high quality of medical devices and be highly effective.

He also clarified that the SFDA set specific standards for devices and dealt with authorities to check conformity of devices, planned to be imported, to the provisions of medical devices and products monitoring regulation.
The Vice Executive President of the SFDA Medical Devices Sector added that no device will enter the Kingdom unless it is approved by one of Global Harmonization Task Force members: "United States, Canada, European Union, Australia and Japan".

In addition, he stated that the regulation aims to protect public health through applying procedures and provisions that insure safety of patients and users of medical devices and products during the stages of manufacturing and marketing, and take actions to guarantee conformity of used and marketed devices and products to all requirements of the regulation.

He explained that the new regulation will be applied on manufacturers, their legal representatives, importers, distributors, all medical devices and products which will be circulated in the Kingdom, contact lenses, surgical laser devices used for cosmetic non medical purposes and their accessories.