1. MDS Statistics for the third Quarter of the year 2012

2. StatusEstablishmentsDevices Accepted1517111505 Incomplete48191 Rejected1939723 Under study4642 Total1588152061 Medical Devices National Registry statistics MDNR MDNR Medical Devices National Registry

3. Establishment ClassLicensedUnder ReviewRejectedTotal Class A 630871 Class B 158213173 Class C 262164327 Class D 6501883 Total 5483103654 Medical Devices Establishments Status MDEL MDEL Medical Devices Establishment License

4. Authorized Representative (AR) LicensedRejectedUnderstudyTotal Manufacturer1205 250841539 AR 28033161 474 MDEL MDEL Medical Devices Establishment License

5. Medical Devices Marketing Authorization MDMA Number of Applications Issued 395 Under Process 218 Waiting for Payment 158 Returned, waiting Re-Submission 683 Draft, waiting Submission 1022 Total 2476 MDMA MDMA Medical Devices Marketing Authorization

6. Total Non-Medical IVD IVDMD 33,36815612,50620,706 Number of cleared Shipments 73,56026318,44954,848 Number of cleared Items 1,602,748,326145,734113,427,2301,489,175,362 Quantity of cleared items 11,490,352,10044,634,1133,500,097,0357,945,620,952 Value of cleared items Cleared shipments

7. Total Non-Medical IVD IVDMD 1,60031,040557 Number of rejected Shipments 11,080268,5982,465 Number of rejected Items 34,733,709 299 2,212,38032,521,030 Quantity of rejected items 123,763,83393,41451,436,56472,233,855 Value of rejected items Rejected shipments

8. Establishment Compliance Process Region201020112012Total Riyadh Province 198417190805 Makkah Province 82138145365 Eastern Province 11324588 Total 2915873801258 ECP ECP Establishment Compliance Process Total number of Establishments Inspection visits until the 3 rd Q 2012

9. Medical Devices Importing license system Applications Medical IVDD’s Non-Medical IVDD’s DistillationsChemicals Status Incomplete 5819430 Accepted 163637947 Rejected 2771425 MDIL MDIL Medical Devices Importing license

10. Nonconforming products observed during inspection visits Product Type 1. Medical Bandages8. Surgical Gloves 2. Medical Braces9. Surgical Bandages 3. IVD Tests10. Electro Cardio Grave Pads 4. Catheter Tubes11. Sphygmomanometer 5. Surgical Blades12. Glucometer 6. Disposable Syringe13. Medical headphones 7. Thermometers14. Pregnancy Test 15. Other Medical Products Quantity: 2,732,785

11. No. of Field Safety Notice by source: NCMDR National Center for Medical Devices Reporting Source 200820092010 20112012TotalPercentage Emergency Care Research InstituteECRI 7492653387 361190020.9% Food and Drug AdministrationUSFDA 108011955151238 790481853.0% Medicine &Healthcare products Regulations Agency MHRA 0149479471 330142915.7% National Competent Authority Report NCAR 59706185 833583.9% National Center for Medical Devices Reporting NCMDR 852164115 814204.6% The Federal Institute for Drug and Medical Devices, Germany BFARM 00035 1011361.5% Swiss Agency for Therapeutic Products, Swaziland Swiss Medic 00010 200.2% The Medical Device Control Office, Hong Kong MDCO 0000 550.1% Total 1154195818722341 17619086100.0%

12. Total 20122011201020092008 No. of Adverse Event 438 391 261272 National Center for Medical Devices Reporting NCMDR

13. NCMDR contact officers Total number of adverse events& FSN’s reports received through NCMDR Website from 2008 till now 858 Adverse eventsFSN 438420 National Center for Medical Devices Reporting is communicating with healthcare facilities (223) (20) Directorates health affairs Total number of NCMDR-Officers representing healthcare facilities and directorates health affairs representatives 269 Total number NCMDR-Officers representing the Medical Devices Establishments and Companies within KSA 371 Total number of weekly reports sent to NCMDR- Officers 196 reports for each NCMDR- officer NCMDR National Center for Medical Devices Reporting