The SFDA has held a celebration on Saturday, the 14th of Thulqida, 1427H, on the occasion of inaugurating the National Registry of Medical Devices and Products in the Kingdom. It was attended by representatives of governmental authorities and companies specialized in medical products and supplies.
D. Alkanhal delivered a speech which includes that the SFDA, represented by its medical devices and products sector and cooperating with the General Administration of Information Technology, has set the National Registry of Medical Devices and Products in the Kingdom for the first time according to the government concern of health services related to citizens.
D. Alkanhal declared that the aim of the Registry is to enroll all establishments, manufacturers, importers, dealers in fields of -medical devices and supplies, laboratory solutions, glasses, contact lenses and their solutions- recognize all medical devices and products that exist in the Kingdom, their sources and licenses acquired from international monitoring authorities, and asses the readiness of medical devices and products private sector towards the commitment of monitoring system requirements which will be launched by the SFDA since this Registry considered a first step toward establishing a comprehensive monitoring system for medical devices and products in the Kingdom.
He also confirmed that the SFDA adopts transparency and communication with the private sector which considered a strategic partner, and in accordance to these strategies the SFDA concerned about the participation of this sector in all activities, as it had organized two workshops in the Chamber of Commerce and Industry in Jeddah as well as in Dammam to issue this Registry and it concluded with this workshop in its headquarter in Riyadh.
In his part, D. Saleh bin Sulaiman Attayar, the General Manager of Medical Devices Sector, analyzed the mechanisms of Registry enrollment and stated that it includes two main steps; the first is making an account for the Registry system user and the second is enrolling the establishment; which contains five items: information about the establishment, the responsible of it, the medical devices and products that the establishment deals with, requirements of after marketing and a ratification of information authenticity form.
D. Attayar clarified that the SFDA, represented by its Medical Devices Sector, concerned about launching this Registry in order to distinguish the current status of medical devices and products as the Kingdom does not have a monitoring system of them as well as the lack of accurate information and data about them, beside that the medical devices and products market in the Kingdom faces competitions between companies and institutions of contrastive levels dealing with devices differ in their quality, effectiveness and their acquired monitoring licenses.