1. Compliance & Enforcement Updates Abdullah Alrasheed Compliance & Enforcement Dept.

2. Contents Objectives Product value chain Requirements Counterfeit MD POEs 2

3. Objective Is to ensure that any medical device that has been authorized to be placed on the KSA market and is found, before it is put into service, to compromise the health or safety of patients, users or third parties, or does not comply with the relevant provisions of the Medical Devices Interim Regulation and its Implementing Rules, is either withdrawn from the market, or subject to appropriate corrective action to eradicate the non-compliance. Ensure establishments are in compliance with SFDA rules and regulations in order to ensure safety, effectiveness and quality of medical devices along with patient and user safety. 3

4. 4 Medical Devices Life Cycle Conception and Design Manufacture Packaging Labelling Importing Sale Use Disposal Pre-market On-market Post-market

5. 5 Development to Disposal Value Chain Design inputs leading to new concept or newer version Testing (inc. verification, validation, & clinical trials) Product is manufactured, packaged & labeled Product is shipped from its manufacturing site via land, air or sea to local warehouse Product is transferred from local warehouse to healthcare provider Marketing and sale Product is operated or used Product is removed after reaching end of its life cycle Description Stakeholders University Manufactur ers Hospitals Manufacture rs Importers Distributors Authorized Represent ative Manufacture rs Importers Distributors Authorized Representati ve Patients Healthcare Providers Patients Healthcare Providers Establishm ents. ApplicationDistributionImportManufacture Concept & Development Disposal

6. Inspection Enforce. 6 Approach

7. 7 Total Number of Inspected Establishments 2010 - 2011 * Up to Nov 23, 2011

8. Requirements Registration, Listing and Establishment Licensing : Establishment must has valid license issued by SFDA. All information of the establishment must be listed and updated at MDNR system ( company details, MDEL information and product list). Staff Qualification Establishments employees must be in a sufficient number, an adequate knowledge, qualification and have a documented training program. Traceability & Identification Establishment must have adequate traceability system supported by written procedures which include a general description of how the applicant will follow to trace individual medical devices through that part of the supply chain with which it is directly involved.

9. Requirements Medical device vigilance system & Control of nonconforming Establishment must have adequate written procedure for medical device Recalls, AE and incidents. Transportation, Handling & Delivery : Ensure that medical devices are properly packed, handled and stored for transportation as well as transported in a suitably vehicle, taking into account the manufacturers instructions with respect to temperature, humidity, vibrations and the risk of physical damage. 9

10. Requirements Storage : general description of the procedure the establishment will follow to comply with the manufacturers requirements for the storage of medical devices it deal with, and an attestation that it will implement and maintain this procedure. 10

11. -Gather all require document (eg. Location map, list of device and recall form). -Communicate with Est. to complete all missing document. Initiate a request Type of Inspection -Scheduling and scoping. -Assign inspection team. -Notified the Establishment. -Receive 2 dates. -Confirm one date -Receive confirmed date. -Print checklist. -Conduct inspection. -Add evidence. Prepare inspection report including findings Submit to Assessment Requester Document review section Inspectors Establishment High level establishment inspection process map 11

12. Communicate findings to establishment and request a Corrective Action Plan 12 Receive and assess follow-up inspection findings Compliance Assessment Department Establishment Receive inspection findings Assess inspection findings High level Establishment Compliance Assessment process map Submit Corrective Action Plan to SFDA Communicate findings to establishment and request a Corrective Action Plan Request follow- up inspection to confirm implementation of corrective actions Close case Request enforcement actions if establishment fails to implement corrective actions

13. Non Compliances Risk Classification Risk classificationCriteria Sever An observation describing a situation that poses or may have the potential to result a tangible risk to public health Moderate An observation related to the failure of an establishment to meet the requirements of SFDA related to medical devices storage, transportation..etc. Indirectly linked to a risk to public health. Minor Not related to public health risk but related to a deviation from the SFDA regulation

14. Establishment Compliance Process system (ECP) ECP is an electronic system which integrated with the MDS electronic systems such as MDNR and MDEL in order to allow inspectors to pull out information and documents needed for the inspection. Objectives: Tasks Automation Compliance history data base Improve efficiency and monitor performance using KPIs.

15. Establishment Compliance Process system (ECP) ECP is an electronic system which integrated with the MDS electronic systems to allow inspectors to pull out information and documents needed for the inspection. Notification received by Establishment

16. Flow Chart of ECP

17. Major reasons for non-compliances: Establishments storage conditions does not meet their products manufacturers requirements. Establishments incapability to identify the status of their products and to track them through the supply chain. Insufficient qualification of the establishments staff. Establishments not updating their MDEL & MDNR information Improper dealing with medical devices incidents & recalls. Inadequate transportation of medical devices. 17

18. Counterfeit Medical Devices & Products Manufacturing counterfeit medical products. Supplying, offering to supply or trafficking in counterfeit medical products. Falsifying documents. 18

19. Medical Devices Anti- counterfeiting 19

20. Ports of Entry Medical Devices are inspected at the following ports of entry:

21. Objective of POE inspection It is a vital protection against the importation of unlicensed, defective or counterfeited medical devices. Working in collaboration with importers, customs brokers and Saudi Customs. the process provides consistent, efficient, and effective controls in relation to medical devices imported via land, sea and air. 21

22. Ensure the submitted documents complies with relevant provisions of SFDA. Ensure the importers are registered in (MDNR). Ensure the importers have obtained (MDEL) license. Ensure the imported medical device has obtained ( MDMA). Ensure there is no recall on the imported Medical Devices. Perform a random Sampling of imported MDs for Inspection. POE Responsibilities

23. Reasons for rejecting shipments at ports of entry: Devices do not meet National requirements with respect to the electrical frequency. Shipping temperature does not meet manufacturer requirements. Absence of temperature indicator/monitor for IVDs shipments. Absence of information about the country of origin. Absence of expiry dates and lot/batch number on IVD shipment invoices. Physical damage to shipped devices. Rejected Shipments at POEs

24. 24 Cleared shipment in 2010 Total Non Medical IVDs IVDsMDs 13,40134 4,0249,343 No. of cleared shipments 4,194,407,65118,699,006927,624,9443,248,083,701 Value of cleared items Rejected shipment in 2010 Total Non Medical IVDs IVDsMDs 5461419126 No. of rejected shipments 20,318,45420,59312,864,0117,433,850 Value of rejected items

25. 25 Total Non Medical IVDs IVDsMDs 2,4327 1,1711,254 No. of cleared shipments 714,544,991912,064317,945,934395,686,993 Value of cleared items Total Non Medical IVDs IVDsMDs 10408420 No. of rejected shipments 2,968,50102,164,887803,614 Value of rejected items Cleared shipment in 1st quarter of 2011 Rejected shipment in 1st quarter of 2011

26. 26 Total Non Medical IVDs IVDsMDs 2,62520 1,1481,457 No. of cleared shipments 944,540,6833,148,929429,676,126511,715,628 Value of cleared items Total Non Medical IVDs IVDsMDs 9107417 No. of rejected shipments 3,121,48302,041,4931,079,990 Value of rejected items Cleared shipment in 2nd quarter of 2011 Rejected shipment in 2nd quarter of 2011

27. 27 Total Non Medical IVDs IVDsMDs 2,15213954 1,185 No. of cleared shipments 1,329,336,5951,881,831257,779,5001,069,675,264 Value of cleared items Total Non Medical IVDs IVDsMDs 11918929 No. of rejected shipments 10,025,34336,3766,070,7413,918,226 Value of rejected items Cleared shipment in 3rd quarter of 2011 Rejected shipment in 3rd quarter of 2011

28. 28 Cleared Shipment 2,988,422,269 SR

29. 29 Rejected Shipment 16,115,327 SR

30. Packing Problems

34. Labeling Problems

37. 37

38. 38 Thank you