Protecting Patients through

safer Medical Devices

Eng. Rami Wail Al Twijri, MPH.

Section Head, Business Sector relations

Saudi Food & Drug Authority

Outlines

Introduction

Pre-Market Systems

What is the best documents to be required to ensure the

safety of Medical products.

Post-Market Surveillance

Examples of Electronic Systems at SFDA to promote

the safety of Medical Device

Counterfeited Medical Devices

• Medical Devices market size increase rapidly.

2013 medical devices market is about 330 B$

and will be around 420 b$ in 2017

(http://decibio.com/ )

• International Medical Devices Regulatory

Forum (IMDRF).

• Asian Harmonization Working Party (AHWP)

Introduction

• Counterfeit medical devices can have adverse

effects including potentially lethal

consequences as they can be non-sterile, of

poor quality, consisting of hazardous(non-

medical grade) materials and questionable

effectiveness.

Counterfeited Medical Devices

• One of the most severe implications of

counterfeit medical devices is clearly the

adverse health implications for consumers.

• Examples

Counterfeited Medical Devices

Counterfeited Medical Devices

Counterfeited Medical Devices

Counterfeited Medical Devices

Counterfeited Medical Devices

SFDA On-line System

MDNR

Establishment

National

Registry

Number

Importers

Distributors

Local Manufactures

Authorised Representatives

MDEL

Importers

Distributors

Authorised Representatives

Establishment

License

Authorised

Representative

License

MDMA

Local Manufactures

Authorised Representatives

Market

Authorisation

Issued to the

Manufacturer

MDNR

Importers

Distributors

Establishment

National

Registry

Updated with

Medical devices

Listing

• MDEL & Establishments Inspection.

• Authorized Representative.

• NCMDR (post-market)

Electronic Systems

MDEL & Establishments Inspection

WHAT?

• MDEL is an on-line enrolment scheme for importers, distributorsand authorised representative of medical devices, located in theKingdom of Saudi Arabia. Local manufacturer involved indistribution must also apply.

WHY?

• License establishments located in Saudi Arabia that areimporting / distribution Medical Device in the KSA.

• License establishments located in Saudi Arabia that areAuthorised Representative for Medical Device in the KSA.

•Registration, Listing and Establishment Licensing

•Staff Qualification

•Traceability & Identification

•Medical device vigilance system & Control of nonconforming

•Transportation & Delivery

•Storage & Handling

•Advertisement

MDEL & Establishments Inspection

Authorized Representative

Manufacturer

AR

Dealing with

SFDAComplete MDMA

Post Market

Surveillance

Inform SFDA of

Incidents

Outside

KSA

Cooperate with

Importers

Distributors

Installation

Maintenance

• Example (Case):

PIP silicon break threaten health of hundreds of women in

the Middle East. The reason of this recall was because of

using non medical silicon on medical purposes. This break is

a reason of spending millions on healthcare facilities and

governmental level. However, having a system such as AR

reduced the cost.

Authorized Representative

• The National Center for Medical Devices

Reporting(NCMDR) receives reports of suspected

medical-devices adverse event and confirmed

product recalls from healthcare practitioners and

devices suppliers within the Kingdom of Saudi

Arabia.

NCMDR

• SFDA personnel investigate all submissions and,when possible, provide technical and clinicalguidance to allow all affected parties (not merelythe original reporter) to avoid or resolve reportedproblems that is related to medical devices.NCMDR’s overarching goal is improving patientand caregiver safety through the distribution ofaccurate, actionable information. Since the system’ssuccess is best ensured by active and ongoingparticipation, SFDA strongly encourages allmembers of the medical community to take part.

(https://ncmdr.sfda.gov.sa/)

NCMDR

• Healthcare facilities within KSA:

– Medical Devices Establishment license (MDEL).

– Authorized Representative (AR).

– Medical Devices Marketing Authorization (MDMA).

What is the best documents to be required to ensure the

safety of Medical products.

• Healthcare facilities outside KSA:

– CE Mark, 510k , or other quality certificate.

– read about it at recall websites ( NCMDR, FDA,

MHRA, etc.) .

– contact regulatory party if available.

What is the best documents to be required to ensure the

safety of Medical products.