Embed Size (px)
Citation preview
MDNR System Establishment Products
Accepted 1230 61867
Rejected 2 24835
In Complete 75 91
Under Study 3 418
Total 1310 87211
Establishment Class
LicensedUnder Review
RejectedWait for Payment
Wait for Certificate
Total
Class A 52 0 0 4 0 56
Class B 109 0 0 22 0 131
Class C 225 0 0 55 0 280
Class D 78 0 0 18 0 96
Total 464 0 0 99 0 563
Medical Devices Authorized Representative Status
Authorized Representative
Legal Manufacturer
Licensed 139 379
Under Review 22 57
Rejected 44 61
Waiting for Payment 29 71
Waiting for Certificate 0 0
Total 232 581
MDMA Status
MDMA Number of Applications
Issued 34
Under Process 52
Waiting for Payment 56
Returned, waiting Re-Submission
183
Draft, waiting Submission 354
Total 679
Riyadh region
Mecca region
Eastern region
Total
Jan 2010 – Sep 2011 254 104 23 381
Total Number of Inspected EstablishmentsTotal Number of Inspected Establishments::
Nonconforming products observed Nonconforming products observed during inspection visitsduring inspection visits
Product type Quantity
Medical Bandages
1,890,685
Medical BracesIVD Tests Catheter TubesSurgical BladesDisposable SyringeThermometersSurgical GlovesSurgical BandagesElectro Cardio Grave Pads
Cleared shipmentsCleared shipments
MD’s IVD’sNon Medical
IVD’s Total
No. of cleared shipments 15,950 9,615 101 25,666
No. of cleared items 42,024 13,763 206 55,993
Quantity of cleared items 1,286,619,103 43,986,133 124,946 1,330,730,388
Value of cleared items 6,132,564,207 2,590,647,934 28,702,823 8,751,914,964
Rejected shipmentsRejected shipments
MD’s IVD’sNon Medical
IVD’s Total
No. of rejected shipments 232 825 1 1,058
No. of rejected items 562 6,675 11 7,248
Quantity of rejected items 1,183,014 701,569 155 1,884,738
Value of rejected items 1,579,2977 27,267,740 56,969 43,117,686
Source 2008 2009 2010 2011 Total Percentage
ECRI 7 492 653 320 1472 %21
FDA 1080 1195 515 1048 3838 %54
MHRA 0 149 478 343 970 %13.5
NCAR 59 70 61 59 249 %3.5
NCMDR 10 59 177 329 575 %8
Total 1156 1965 1884 2099 7104 100%
No. Of recalls and adverse events by source:No. Of recalls and adverse events by source:
No. Of Adverse event from 2008 to (22/11/2011) by years:
Source 2008 2009 2010 2011 Total
NCMDR 2 7 12 524 545
Thank YouThank You
