A royal decree was issued on Feb.13, 2007 assigned the responsibility for regulating medical devices, in vitro diagnostic devices, prescription eye glasses, contact

lenses and their solutions to the Saudi Food and Drug Authority (SFDA)

A council of ministers decision was issued on June 18, 2007

gives the SFDA full authority to issue guidance that include rules and procedures of registering medical devices

establishments and their products

The LThe Law of Saudi Food aw of Saudi Food and Drug Authorityand Drug Authority

The MDPRC project is carried out in cooperation with the Emergency Care and Research Institute (ECRI) in America. The main objectives are:

- To launch a fully functional web-based MDPRC to collect reports and recalls. - Assisting the MDS in the implementation of the system. - Training MDS personnel on reporting and accident investigation.

Goals of MDPRCGoals of MDPRC

• To keep safety on track with the emerging To keep safety on track with the emerging medical devices marketmedical devices market

• To maintain a sharing information policy with To maintain a sharing information policy with other organization according to Global other organization according to Global Harmonization Task Force (GHTF) mission Harmonization Task Force (GHTF) mission

• To reduce likeliness of occurrence of adverse To reduce likeliness of occurrence of adverse incidentsincidents

• To prevent likeliness of occurrence of previous To prevent likeliness of occurrence of previous adverse incidents.adverse incidents.

• Increasing the overall healthcare proficiency for Increasing the overall healthcare proficiency for patientspatients

• To protect users and patients from undesired To protect users and patients from undesired results of faulty devices.results of faulty devices.

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

Goals of MDPRCGoals of MDPRC

Importance of MDPRC The

As part of its public mandate to protect patients and As part of its public mandate to protect patients and health professionals, the SFDA maintains an online health professionals, the SFDA maintains an online MDPRC. MDPRC.

The purpose of the system is to identify events in The purpose of the system is to identify events in which:which:

• A patient, staff member, or visitor may have A patient, staff member, or visitor may have suffered harm as a result of failure of a medical suffered harm as a result of failure of a medical device device

Importance of MDPRC The

• Medical devices fail and harm the Medical devices fail and harm the environment environment

• Significant medical devices failures occur Significant medical devices failures occur and are likely to recur and harm people or and are likely to recur and harm people or the surroundings.the surroundings.

RecallsRecalls

A recall is an action taken to address a problem with A recall is an action taken to address a problem with

a medical device that violates SFDA regulation. a medical device that violates SFDA regulation.

Recalls occur when a medical device is defective, Recalls occur when a medical device is defective,

when it could be a risk to health, or when it is both when it could be a risk to health, or when it is both

defective and a risk to healthdefective and a risk to health

RecallsRecalls

• 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.

RecallsRecalls

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

• Inspecting the device for problems Inspecting the device for problems • Repairing the device Repairing the device • Calibrating and adjusting settings on the device Calibrating and adjusting settings on the device • Re-labeling the device Re-labeling the device • Destroying device Destroying device • Notifying patients of a problem Notifying patients of a problem

Medical Device recalls classified according to theMedical Device recalls classified according to the potential risk to public health.potential risk to public health.

Who makes the recall?

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

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

• notifies SFDA.notifies SFDA.• Legally, SFDA can require a company to recall a Legally, SFDA can require a company to recall a

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

When a company recalls a medical device, it When a company recalls a medical device, it • Contacts directly the customers who Contacts directly the customers who

received the product from them. received the product from them. • Reach others who need to be notified (for Reach others who need to be notified (for

example, by issuing press releases). example, by issuing press releases). • supplies information to help users identify supplies information to help users identify

the product and take steps to minimize the product and take steps to minimize health consequences; and takes action to health consequences; and takes action to prevent the problem from happening prevent the problem from happening again.again.

Who makes the recall?

What is a problem What is a problem

reportreport?? It is the report of any event that lead or might lead to It is the report of any event that lead or might lead to

undesired or unexpected issues regarding safety of undesired or unexpected issues regarding safety of patients, users or any other person. This may patients, users or any other person. This may include the following:include the following:

• Problems with the design of the deviceProblems with the design of the device• Untrained or unaware staffUntrained or unaware staff• Carelessness in useCarelessness in use• Uninstructed modificationsUninstructed modifications• Inadequate maintenanceInadequate maintenance• Inappropriate conditions: storage, temperature Inappropriate conditions: storage, temperature

and useand use

What should be reportedWhat should be reported??

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

• DeathDeath• Serious injurySerious injury• Need for hospitalization, surgical or medical Need for hospitalization, surgical or medical

interventionintervention• Uncertainty of resultsUncertainty of results

Medical devices problem Medical devices problem reporting formsreporting forms

MDPR form for Healthcare ProvidersMDPR form for Healthcare Providers• MDPR can be entered by healthcare providers MDPR can be entered by healthcare providers

through through http://mdprc.sfda.gov.sa Personal Info., Device Info. and Problem DescPersonal Info., Device Info. and Problem Desc..

• The item will enter into the system for The item will enter into the system for investigation.investigation.

• an E-mail will be automatically sent to the an E-mail will be automatically sent to the reporter with the Confirmation Code and a link reporter with the Confirmation Code and a link to access the Problem Report.to access the Problem Report.

Medical devices problem Medical devices problem reporting formsreporting forms

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.

MDPR form for Manufacturers and SuppliersMDPR form for Manufacturers and Suppliers • All medical devices manufacturers and All medical devices manufacturers and

suppliers must first register suppliers must first register http://mdprc.sfda.gov.sa in order to enter in order to enter Devices Recalls.Devices Recalls.

• After registering, the SFDA Administrator reviews the information and activates the account. Then, a manufacturer or supplier is able to log into the account.

Medical devices problem Medical devices problem reporting formsreporting forms

SecuritySecurity andand Confidentiality of DataConfidentiality of Data

SFDA will share all submitted information wither SFDA will share all submitted information wither recalls or reports with ECRI and other global recalls or reports with ECRI and other global authorities, and SFDA will ensure to hide the authorities, and SFDA will ensure to hide the identity of the person who submitted the identity of the person who submitted the information and will not share personal data information and will not share personal data with any other parties. All personal data will be with any other parties. All personal data will be used within SFDA only.used within SFDA only.