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Ensuring compliance with medical device regulations and enforcing corrective actions for non-compliance in the KSA market.
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Compliance & Enforcement Updates Abdullah Alrasheed Compliance & Enforcement Dept.
Contents • Objectives • Product value chain • Requirements • Counterfeit MD • POEs
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not comply with the relevant provisions of the Medical Devices Interim Regulation and its Implementing Rules, is either withdrawn from the market, or subject to appropriate corrective action to eradicate the non-compliance.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.
Medical Devices Life Cycle Conception and Design Manufacture Importing Packaging Labelling Sale Use Disposal Pre-market On-market Post-market
Concept & Development Manufacture Import Distribution Application Disposal Description Stakeholders “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 • University • Manufacturers • Hospitals • Manufacturers • Importers • Distributors • Authorized Representative • Manufacturers • Importers • Distributors • Authorized Representative • Patients • Healthcare Providers • Patients • Healthcare Providers • Establishments.
Approach Inspection Enforce.
Total Number of Inspected Establishments2010 - 2011 * Up to Nov 23, 2011
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.
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 manufacturer’s instructions with respect to temperature, humidity, vibrations and the risk of physical damage.
Requirements Storage : general description of the procedure the establishment will follow to comply with the manufacturer’s requirements for the storage of medical devices it deal with, and an attestation that it will implement and maintain this procedure.
Type of Inspection Initiate a request -Gather all require document (eg. Location map , list of device and recall form). -Communicate with Est. to complete all missing document. High level establishment inspection process map • -Scheduling and scoping. • Assign inspection team. • Notified the Establishment. -Receive confirmed date. -Print checklist. -Conduct inspection. -Add evidence. Prepare inspection report including findings -Receive 2 dates. -Confirm one date Submit to Assessment
Receive and assess follow-up inspection findings Close case Request enforcement actions if establishment fails to implement corrective actions High level Establishment Compliance Assessment process map Communicate findings to establishment and request a Corrective Action Plan Request follow- up inspection to confirm implementation of corrective actions Assess inspection findings Communicate findings to establishment and request a Corrective Action Plan Receive inspection findings Communicate findings to establishment and request a Corrective Action Plan Compliance Assessment Department Submit Corrective Action Plan to SFDA Establishment
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.
Establishment Compliance Process system (ECP) Notification received by Establishment 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.
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.
Counterfeit Medical Devices & Products • Manufacturing counterfeit medical products. • Supplying, offering to supply or trafficking in counterfeit medical products. • Falsifying documents.
Ports of Entry Medical Devices are inspected at the following ports of entry:
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.
POE Responsibilities • 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.
Rejected Shipments at POEs 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.
Cleared shipment in 2010 Rejected shipment in 2010
Cleared shipment in 1st quarter of 2011 Rejected shipment in 1st quarter of 2011
Cleared shipment in 2nd quarter of 2011 Rejected shipment in 2nd quarter of 2011
Cleared shipment in 3rd quarter of 2011 Rejected shipment in 3rd quarter of 2011
Cleared Shipment 2,988,422,269 SR
Rejected Shipment 16,115,327 SR
