JEDDAH, 21 November 2007 — The Saudi Food & Drugs Authority (SFDA) announced yesterday during a workshop at the Jeddah Chamber of Commerce and Industry (JCCI) that it was launching a national registry for medical devices.
“The Medical Devices National Registry (MDNR) system that will go into effect next year aims at checking on medical devices available in the market and hospitals,” said Dr. Saleh Al-Tayyar, director general of the medical devices sector at the SFDA.
“This will allow the authority to know the origins of the medical devices . . . This will help us shed light on the safety of these devices,” he added.
This registry would help SFDA officials monitor importers, exporters, manufacturers, traders and anyone else who works in this field to ensure that they comply with regulations.
With the new system, no device will be allowed to enter the county unless it is approved by the SFDA.
“This system will allow us to know what medical devices are available in the market. When I say ‘medical devices’ I include medical equipment, consumables, medical glasses, contact lenses, diagnostic supplies and a wide range of other medical devices,” said Al-Tayyar.
Registration in the MDNR will be voluntary initially, but will become mandatory after the first year.
SFDA will also launch in January a system to investigate incidence of malpractice in hospitals possibly caused by faulty medical devices. If the device itself is found to have caused injury to a patient, the manufacturer will be held responsible. If it was an error resulting from improper use of a device then hospitals and doctors will be held responsible.
The JCCI hosted the workshop as a way of facilitating communication between the SFDA and the private sector involved in medical devices.
“We are responsible for introducing this section of the business sector to the authority,” said Adnan Mandoura, director of the business and committees sector at the JCCI.
