On the 21st of November 2007 the Health Regulatory Authority (SFDA) announced 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.

One of the large challenges to a countries health safety is the wide variety of medical devices both tested and untested. The national registry for all medical devices is being made available on a voluntary basis for the first year after which all devices will have to be registered before they may be used in Saudi Arabia. The web portal will become a national data bank of all devices used in the country with all the required regulatory and licensing documents also being stored in the data base

Situation

The Saudi Food and Drug Authority (SFDA) was established under the Council of Ministers resolution no (1) dated 07/01/1424 H (corresponding to 10 March 2003G) as an independent corporate body that directly reports to the Premier. The Authorities objective is to ensure the safety of food and drug for humans and animals and the safety of biological and chemical substances as well as electronic products used in the medical field.

It is difficult enough to be aware of what new equipments have come on to the market, it is impossible using hand methods to keep up to date with the avalanche of new equipments coming on to the market, their functions, patents, licensing etc.

“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.

Solution

The authority teamed up with Interactive Saudi Arabia and developed a solution based on Microsoft Visual Studio.NET 2005 and MS SQL Server 2005, the Medical Devices National Registry (MDNR). Suppliers will be able to register as many types of equipment as they like and track the progress of the registration having opened up a unique account with their own logon ID and password.

We’ve selected Microsoft technology for several reasons: it is quick to implement, we can build a custom applications to run on top and it will provide opportunities for future growth.

Dr. Saad Al Kasabi , General Manager of Information Technology Sector , Saudi Food & Drug Authority (SFDA)

The development team also used Microsoft Visual C#® 2005 development tool and Web forms to build forms-based Web pages and ASP.NET server controls to create and program common user interface elements.

Using MDNR

The system allows suppliers to register equipment and follow the progress of the registration. To ease the learning curve there is a full training package both on line and available on CD and booklet. From the MDNR point of view it allows officers to monitor the applications, evaluate them, correspond with applicants where there is a shortfall of information and transfer responsibility for a case when an officer goes on leave or becomes overloaded.

Management has full visibility of the officer’s case loads and the progress made on each case and can intervene at any time when required.

Benefits

Built on Microsoft products and technologies MDNR brings a new transparency to the medical equipment used and licensed in Saudi Arabia. At the touch of a button it will be possible to determine what equipments are deployed and where they are deployed in the Kingdom.

Fast, Collaborative Access to Data

With the DMNR the information is available to all that require it. The suppliers can maintain their own data thus ensuring that it is correct at all times, the officials can easily see what documentation or certification is missing and ensure that the supplier complies with all the governments’ requirements.

Improved safety

With the new system, no device will be allowed to enter the county unless it is approved by 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,” said Dr. Saleh Al-Tayyar, director general of the medical devices sector at the SFDA.