MDS Statistics for the third Quarter of the year 2012

StatusEstablishmentsDevices Accepted Incomplete48191 Rejected Under study4642 Total Medical Devices National Registry statistics MDNR MDNR Medical Devices National Registry

Establishment ClassLicensedUnder ReviewRejectedTotal Class A Class B Class C Class D Total Medical Devices Establishments Status MDEL MDEL Medical Devices Establishment License

Authorized Representative (AR) LicensedRejectedUnderstudyTotal Manufacturer AR MDEL MDEL Medical Devices Establishment License

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

Total Non-Medical IVD IVDMD 33, ,50620,706 Number of cleared Shipments 73, ,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

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

Establishment Compliance Process Region Total Riyadh Province Makkah Province Eastern Province Total ECP ECP Establishment Compliance Process Total number of Establishments Inspection visits until the 3 rd Q 2012

Medical Devices Importing license system Applications Medical IVDD’s Non-Medical IVDD’s DistillationsChemicals Status Incomplete Accepted Rejected MDIL MDIL Medical Devices Importing license

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

No. of Field Safety Notice by source: NCMDR National Center for Medical Devices Reporting Source TotalPercentage Emergency Care Research InstituteECRI % Food and Drug AdministrationUSFDA % Medicine &Healthcare products Regulations Agency MHRA % National Competent Authority Report NCAR % National Center for Medical Devices Reporting NCMDR % The Federal Institute for Drug and Medical Devices, Germany BFARM % Swiss Agency for Therapeutic Products, Swaziland Swiss Medic % The Medical Device Control Office, Hong Kong MDCO % Total %

Total No. of Adverse Event National Center for Medical Devices Reporting NCMDR

NCMDR contact officers Total number of adverse events& FSN’s reports received through NCMDR Website from 2008 till now 858 Adverse eventsFSN 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