Embed Size (px)
Citation preview
POST MARKET SURVEILLANCE
IN SAUDI ARABIA
Dr. Saleh S. Al-Tayyar
Vice Executive President - Medical Devices Sector
Saudi Food and Drug Authority
Chair of AHWP
Mr. Abdullah Thabit. MT, MBA, EPSF
Director of Consumer Awareness - Medical Devices Sector
Saudi Food and Drug Authority
SECOND GLOBAL FORUM ON MEDICAL DEVICES
GENEVA, SWITZERLAND
SATURDAY NOV 23, 2013
OUTLINES
� Medical devices life cycle
� Post Market surveillance
� Vigilance
� Reporting Medical Devices Adverse Events
� Market control
� Establishment Inspection
� Statistics
� How to report to NCMDR
MEDICAL DEVICES LIFE CYCLE
Conception
and DesignManufacture
Packaging
LabellingDisposalUseSaleAdvertising
Pre-Market On-Market Post-Market
POST MARKET SURVEILLANCE (PMS)
PMSPMS
Proactive Activities
( Market Control)
Proactive Activities
( Market Control)
Batch Release
Testing
Batch Release
Testing
Establishments
Inspection
Establishments
Inspection
Reactive
Activities
Reactive
Activities
The Vigilance
System
The Vigilance
System
A PICTORIAL VIEW OF PMS
Post market
Surveillance
Vigilance
Post-Market Surveillance
Information are used for:
�Injury prevention.
� Product improvement.
� Development of standards.
� Regulatory refinement.
VIGILANCE
Medical device vigilance is a process whereby an adverse
event involving a medical device that is authorized to be
placed on the Saudi market and put into service, of which
the manufacturer has been informed, is investigated by
the manufacturer and reported to the SFDA, where
appropriate.
Where justified, the manufacturer and/or the SFDA shall
take all appropriate measures to reduce or remove the
likelihood of the incident occurring again.
REPORTING MEDICAL
DEVICES ADVERSE EVENTS
MD’s
AE
Why
?
Who
?
When
?
What
?
WHY ARE THEY IMPORTANT ?
� Improve protection of health and safety of patients, users
and others.
� Disseminate relevant device related information which may
reduce the likelihood of, or prevent repetition of adverse
events, or alleviate consequences of such repetition.
� Encourage collaboration between manufacturers and
health care facilities to identify and investigate adverse
events associated with medical devices and take
appropriate action.
� Provide a database of information on the safety and
performance of medical devices suitable for exchange of
adverse events information with other Regulatory
Authorities
WHY ARE THEY
IMPORTANT…cont’
� In most cases, the establishment (manufacturer,
authorized representative, importer and distributor) recalls
a medical device on its own (voluntarily).
� Legally, SFDA can require an establishment to issue a FSCA
related to their medical device
This happens when an establishment refuses to conduct a
voluntary recall of a device that is involved in ( serious
injury, death or might lead to)
WHO REPORTS?
IMMEDIATE
� Adverse events that result in unanticipated death or
unanticipated serious injury or represent a serious
public health threat must be reported immediately by
the manufacturer ,authorized representative, importer
and distributor.
WHEN TO REPORT?
� All other reportable events must be reported as soon as
possible by the manufacturer, authorized representative,
importer and distributor but not later than 30-elapsed
calendar days following the date of awareness of the
event.
WHEN TO REPORT…cont’
� Any malfunction or deterioration in the characteristics
and/or performance of a medical device, as well as any
inadequacy in the labeling or the instructions for use,
which has led, or might have led, to the death of a
patient, user or third person, or to a serious
deterioration in the state of health of a patient, user or
third person.
WHAT SHOULD BE REPORTED?
MARKET CONTROL
Establishment
Inspection
Device
Inspection
Port Of
Entries
Establishment
Inspection
Storage Condition
Handling
Transportation
Traceability
Information
during licensing
procedure
Staff Qualification
ESTABLISHMENT INSPECTION
SOURCE 2008 2009 2010 2011 2012 2013 TOTAL
Emergency Care Research Institute ECRI 7 492 653 387 500 282 2321
Food and Drug Administration USFDA 1080 1195 515 1238 1199 820 6047
Medicine &Healthcare products Regulations
AgencyMHRA - 149 479 471 440 302 1841
National Competent Authority Report NCAR 59 70 61 85 124 98 497
National Center for Medical Devices Reporting NCMDR 8 52 164 115 109 50 498
The Federal Institute for Drug and Medical
Devices, Germany BfARM - - - 35 101 210 346
Swiss Agency for Therapeutic Products,
Swaziland
Swiss
Medic - - - 10 10 92 112
The Medical Device Control Office, Hong Kong MDCO - - - - 5 0 5
Therapeutic Goods Administration TGA - - - - - 99 99
Total 1154 1958 1872 2341 2488 1953 11766
STATISTICS
No. of field safety Notice by source (2008 to 3rdQuarter 2013) :
Total201320122011201020092008No. of
Adverse
Event 52568410261272
No. of Adverse Events (2008 to 3rdQuarter 2013)
STATISTICS
Status No. of Est.
Inspection Report under
process 109
Corrective Action in progress 104
Case closed 595
Enforcement Action 212
Total 1020
ESTABLISHMENTS
INSPECTION
(JAN 2010 –2013 3rd QUARTER)
10%
58%
21%
11%
Corrective Action in progress Case closed
Enforcement Action Report under process
TotalNon-Medical IVDIVDMD
2,250111,271968Number of rejected
Shipments
15,9157410,0075,834Number of rejected
Items
45,325,803280,4544,535,77440,509,575Quantity of rejected
items
54,617,885107,34317,752,87036,757,673Value of rejected
items (US $)
STATISTICS
Ports of Entry (POE’s) Rejected shipments (2008 to 3rdQuarter 2013)
CLEARED SHIPMENTS
TotalNon-Medical
IVDIVDMD
46,95923416,69930,026Number of cleared
Shipments
100,66134824,49775,816Number of cleared
Items
2,710,434,417307,819205,309,6352,504,816,963Quantity of cleared
items
4,580,122,03713,890,7971,360,315,6893,205,915.550Value of cleared
items (US $)
AND REMEMBER . . .
We can’t address issues we don’t know about…
PLEASE REPORT
HOW TO REPORT?
www.sfda.gov.sa� E-mail:
� Phone + 966 11 275 9222
� Fax + 966 11 275 7245
THANK YOU
