1. MDNR SystemEstablishmentProducts Accepted123061867 Rejected224835 In Complete7591 Under Study3418 Total131087211

2. Establishment Class Licensed Under Review Rejected Wait for Payment Wait for Certificate Total Class A52004056 Class B10900220131 Class C22500550280 Class D780018096 Total46400990563

3. Medical Devices Authorized Representative Status Authorized Representative Legal Manufacturer Licensed139379 Under Review2257 Rejected4461 Waiting for Payment2971 Waiting for Certificate00 Total232581

4. MDMA Status MDMANumber of Applications Issued34 Under Process52 Waiting for Payment56 Returned, waiting Re- Submission 183 Draft, waiting Submission354 Total679

5. Riyadh region Mecca region Eastern region Total Jan 2010 – Sep 201125410423381 Total Number of Inspected Establishments:

6. Nonconforming products observed during inspection visits Product typeQuantity Medical Bandages 1,890,685 Medical Braces IVD Tests Catheter Tubes Surgical Blades Disposable Syringe Thermometers Surgical Gloves Surgical Bandages Electro Cardio Grave Pads

7. Cleared shipments Total Non Medical IVD’s IVD’sMD’s 25,6661019,61515,950No. of cleared shipments 55,99320613,76342,024No. of cleared items 1,330,730,388124,94643,986,1331,286,619,103Quantity of cleared items 8,751,914,96428,702,8232,590,647,9346,132,564,207Value of cleared items

8. Rejected shipments Total Non Medical IVD’s IVD’sMD’s 1,0581825232 No. of rejected shipments 7,248116,675562 No. of rejected items 1,884,738155701,5691,183,014 Quantity of rejected items 43,117,68656,96927,267,7401,579,2977 Value of rejected items

9. Source 2008200920102011Total Percentage ECRI7492653320 1472%21 FDA108011955151048 3838%54 MHRA0149478343 970%13.5 NCAR59706159 249%3.5 NCMDR1059177329 575%8 Total11561965188420997104100% No. Of recalls and adverse events by source: No. Of recalls and adverse events by source:

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

11. Thank You