1. Incident Reports and field Safety Corrective Action ( FSCA) Eng. Essam M. Al-Mohandis Executive Director of Surveillance and Biometrics

2. Medical Devices Life Cycle Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal Pre-market On-market Post-market

3. Postmarket Surveillance Collection of information on the quality, safety and performance of medical devices; Assessment / Evaluation; Investigation; and Reaction to data on medical devices performance after placed on the market.

4. Postmarket Surveillance Inputs 1.Healthcare facilities & public complains. 2. Int’l and local establishments (Manufacturers/AR, Distributors ). 3. Other int’l regulatory authorities. 4. NCMDR membership ( NCAR / SADS)

5. What should be Reported? 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. hat W W

6. 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 or distributor. All other reportable events must be reported as soon as possible by the manufacturer, authorized representative, importer or distributor following the date of awareness of the event (according to GHTF jurisdiction issuing market authorization). When to report ? W W hen

7. Medical devices subjected to Field safety notice distributed in KSA market, the establishment shall: Maintain traceability system for surveillance purposes. Report to SFDA any FSN/ adverse event might become aware of its occurrence online, through the following link: (http://ncmdr.sfda.gov.sa).http://ncmdr.sfda.gov.sa Provide list of: - related customer/s planned to notified (hospitals, clinics, public…etc ) and - affected medical devices placed on KSA market as well as placed in services. Submit a planed action for reviewing & approval by SFDA-NCMDR.

8. Medical devices subjected to Field safety notice distributed in KSA market, the establishment shall: Cont… Submit determinant date for implementing agreed on action plan & closing the FSN. Any related communication to FSN with concerned customer/s shall approved by SFDA before send out. Periodic submission of progress report concerning the FSN approved action. Effectiveness checks reports, showing action plan implemented and FSN’s closure. Determine depth of the FSN’s (The FSN’s may affect other party/ies in the supply chain e.g. Lay person, retail and the wholesale.etc)

9. MDS - IR7 MDS - IR7

10. Surveillance & Biometrics Executive Department Statistics

11. No. Of FSCA from 2008 to (22/11/2011) by source: Source 2008200920102011Total Percentage ECRI7492653375 152721.4% FDA108011955151184 397455.6% MHRA0149479413 104114.6% NCAR59706173 2633.7% NCMDR852164103 3274.6% BfArM00011 0.2% Total11541958187221597143100.0%

12. No. Of Adverse event from 2008 to (22/11/2011) by years: Source 2008200920102011Total NCMDR2712524 545

13. Total FSCA where corrective actions implemented & closed are equal to 4083 which %57 of the total. Total FSCA and adverse events reflect unrecognized distributors are equal to 1541 which 21.6% of the total. Total FSCA and adverse events that transferred to compliance & enforcement are equal to 112 which 0.1% of the total ( up to date).

14. SBED is communicating with 221 healthcare facilities 18 Directorates health affairs Total number of SBED-Officers representing healthcare facilities and health regional agencies representatives 261 Biomedical Engineers Nurses 23625 Total number of SBED-Officers for Establishments within KSA 297

17. Accessing the National Center for Medical Devices Reporting SFDA

18. How to access NCMDR? Step1. Go to www.sfda.gov.sa/En/Home/www.sfda.gov.sa/En/Home/ Step2. Click on Medical Devices iconStep3. Click on MDES icon

19. Step 4. Click on NCMDR icon How to access NCMDR?...cont

20. Challenges / areas of improvement 1. Limited No. of establishments that report reportable adverse events to SFDA through NCMDR. 2. Limited No. of registered establishments officers in the NCMDR ( Total number of the registered officers in the system 297 while registered establishments in the MDNR are 1200 ?? ). 3. Slowness in response from the establishments on their medical devices subjected to FSN they marketed in KSA.

21. Challenges / areas of improvement …Cont. Challenges / areas of improvement …Cont. 5.Inaccurate information in official letters issued by establishments on their planned corrective action. 4. Non-complying with SFDA requirements during follow up communication with the establishments.

22. Thank You ncmdr-md@sfda.gov.sa