22 Safar 1430 (H) Equal 17 February 2009 (G)

Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

· diagnosis, prevention, monitoring, treatment or allevi­ation of disease,

· diag­nosis, monitoring, treatment, alleviation of or com­pensation for an injury e.g. disinfection substances , etc

· inves­tigation, replacement, modification, or support of the anatomy or of a physiologi­cal process e.g. prescription eye glasses , aids for disabled/handicapped people, etc

· supporting or sustaining life,

· con­trol of conception,

· disinfection of medical devices,

· providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;

and

which does not achieve its primary intended action in or on the human body by pharmaco­logical, immunological or metabolic means, but which may be assisted in its intended function by such means.

What is the Medical Device Data Base(MDDB) ?

The Saudi Food and Drug Authority represented by the Medical devices sector in cooperation with Emergency Care Research Institute (ECRI) is very pleased to offer to the Saudi hospitals both public and private six highly specialized databases that contain valuable information related to medical devices .These data base are:

Health Device System : A database that provides hazard reports, product evaluations, precautions for use and other important information to support accident investigation and continuing investigation.

Health Devices Alerts and MAUDE : Two searchable databases of worldwide reports on medical device problems, recalls and evaluations. The two databases currently have over 1.5 million reports. They are updated weekly .

Healthcare Product Comparison System : A searchable database for 450 types of capital equipment, provides definitions, operating principles, a general description of risks, specialized terminology, supplier data, applicable standards and comparative specifications.

Health Devices Source base and UMDNS : A searchable database of medical device manufacturers worldwide with contact numbers, standard UMDNS nomenclature and device definitions. This database is updated monthly.

TARGET : A technology assessment database of emerging healthcare technologies and their state of "ripeness" for adoption and the reliability of related clinical studies. Useful for physicians and healthcare planners.

Healthcare Standards : A searchable database of 38,000 standards, regulations and laws related to healthcare., This database is updated monthly.

· To establish a database of all establishments, manufacturers, agents and suppliers working in the field of medical devices, in vitro diagnostics, prescription eye glasses, contact lenses and their solutions.

· To measure the readiness of medical devices establishments in conforming to the regulatory requirements.

Who Should Enroll?

The following parties who operate their businesses in Saudi Arabia are invited to enroll.

· Manufacturers of medical devices, in vitro diagnostics, prescription eye glasses, contact lenses and their solutions.

· Exporters and importers of medical devices, in vitro diagnostics, prescription eye glasses, contact lenses and their solutions.

· Distributors/vendors of medical devices, in vitro diagnostics, prescription eye glasses, contact lenses and their solutions.

What is the National Center for Medical Devices Reporting (NCMDR)?

NCMDR is devoted to receive the technical problem reports and feedback information about any medical devices malfunction from hospitals and healthcare facilities all around KSA, studying them and working together with manufacturers and suppliers to take the right action and assuring the proper safe performance.

The center also aims to cooperate with the other international problem reporting centers to exchange reports received about medical devices used anywhere. Medical Devices Sector has membership of AHWP which work closely with Global Harmonization Task Force (GHTF).

Establishment of NCMDR was in order to achieve following goals to:

· Keep safety on track with the emerging medical devices market

· Maintain a sharing information policy with other organization according to Global Harmonization Task Force (GHTF) mission

· Reduce likeliness of occurrence of adverse incidents

· Prevent likeliness of occurrence of previous adverse incidents.

· Increase the overall healthcare proficiency for patients

· Protect users and patients from undesired results of faulty devices.

· Maintain a blame-free relation with manufacturers, suppliers and hospitals in order to increase communication efficiency and certainty of accidents.

It is the report of any event that leads or might lead to undesired or unexpected issues regarding safety of patients, users, janitors or any other person. This may include the following:

· Problems with the design of the device

· Untrained or unaware staff

· Carelessness in use

· Uninstructed modifications

· Inadequate maintenance

· Inappropriate conditions: storage, temperature and use

All adverse incidents, safety or quality issues regarding medical devices that caused or might cause one or all of the following:

· Death

· Serious injury

· Need for hospitalization, surgical or medical intervention

· Uncertainty of results

After all three sections(personal information, devices information and problem description) of the Problem Report have been completed; the item will enter into the system for investigation as well as an E-mail will be automatically sent to the reporter with the Confirmation Code and a link to access the Problem Report. The Confirmation code allows users to access previously entered Problem Reports. When accessing previously entered Problem Reports, additional information can be appended to the original description. These information do not alter information entered initially. SFDA personal may modify the original text to conform with industry standard nomenclature.

What does Recalls mean?

 A recall is an action taken to address a problem with a medical device that violates SFDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

A medical device recall doesn’t always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed.

Examples of the types of actions that may be considered recalls:

· Inspecting the device for problems

· Repairing the device

· Calibrating and adjusting settings on the device

· Re-labeling the device

· Destroying device

· Notifying patients of a problem

In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates SFDA law, it

· recalls the device (through correction or removal); and

· Notifies SFDA.

Legally, SFDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death.

When a company recalls a medical device, it

· contacts directly the customers who received the product from them, and takes steps to reach others who need to be notified (for example, by issuing press releases or providing detailed instructions);

· Supplies information to help users identify the product and take steps to minimize health consequences; and takes action to prevent the problem from happening again.