protecting patients through safer medical devices - rami al twijri
TRANSCRIPT
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
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.