Compliance & Enforcement
Updates
Abdullah AlrasheedCompliance & Enforcement Dept.
Contents
• Objectives• Product value chain• Requirements• Counterfeit MD• POEs
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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not comply with the relevant provisions of the Medical Devices Interim Regulation and its Implementing Rules, is either withdrawn from the market, or subject to appropriate corrective action to eradicate the non-compliance.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.
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Medical Devices Life Cycle
Conception and Design
Manufacture Packaging Labelling
Importing Sale Use Disposal
Pre-market On-market
Post-market
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“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
Des
crip
tion
Sta
keho
lder
s
University
Manufacturers
Hospitals
Manufacturers
Importers Distributors Authorized
Representative
Manufacturers
Importers Distributors Authorized
Representative
Patients Healthcare
Providers
Patients Healthcare
Providers Establishm
ents.
ApplicationDistributionImportManufactureConcept &
DevelopmentDisposal
Est.
MD
POE
AssesInspection Enforce.
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Approach
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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 QualificationEstablishments employees must be in a sufficient number, an adequate knowledge, qualification and have a documented training program .
Traceability & IdentificationEstablishment 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.
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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.
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-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 revie
w section
Inspectors
Establishment
High level establishment inspection process map
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Comm
unicate findings to
establishment
and request a Corrective Action Plan
Com
mun
icat
e fin
ding
s to
es
tabl
ishm
ent
and
requ
est a
Co
rrec
tive
Actio
n Pl
an
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Receive and assess follow-up inspection
findings
Compliance Assessment Department
Establishment
Receive inspection
findingsAssess
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
Non Compliances Risk Classification
Risk classification Criteria
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
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)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
Flow Chart of ECP
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
Counterfeit Medical Devices & Products
• Manufacturing counterfeit medical products.• Supplying, offering to supply or trafficking in
counterfeit medical products.• Falsifying documents.
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Medical Devices Anti- counterfeiting
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Ports of EntryMedical Devices are inspected at the following ports of entry:
Code Port RegionRDP Dry Port
RiyadhRAP King Khaled international airport
JAP King Abdul-Aziz international airport Jeddah
JSP Jeddah Islamic sea port
DAP King Fahad international airport
DammamDCP King Fahad causeway
DSP King Abdul-Aziz sea port
BBP Batha port, UAE border Al-BathaHBP Haditha port, Jordan border Quariat
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.
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• 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
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
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Cleared shipment in 2010
TotalNon Medical
IVD’s IVD’s MD’s
13,401 34 4,024 9,343
No. of cleared
shipments
4,194,407,651 18,699,006 927,624,944 3,248,083,701
Value of cleared items
Rejected shipment in 2010
TotalNon Medical
IVD’s IVD’s MD’s
546 1 419 126No. of
rejected shipments
20,318,454 20,593 12,864,011 7,433,850Value of rejected
items
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TotalNon Medical
IVD’s IVD’s MD’s
2,432 7 1,171 1,254No. of
cleared shipments
714,544,991 912,064 317,945,934 395,686,993Value of cleared items
TotalNon Medical
IVD’s IVD’s MD’s
104 0 84 20No. of
rejected shipments
2,968,501 0 2,164,887 803,614Value of rejected
items
Cleared shipment in 1st quarter of 2011
Rejected shipment in 1st quarter of 2011
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TotalNon Medical
IVD’s IVD’s MD’s
2,625 20 1,148 1,457No. of
cleared shipments
944,540,683 3,148,929 429,676,126 511,715,628Value of cleared items
TotalNon Medical
IVD’s IVD’s MD’s
91 0 74 17No. of
rejected shipments
3,121,483 0 2,041,493 1,079,990Value of rejected
items
Cleared shipment in 2nd quarter of 2011
Rejected shipment in 2nd quarter of 2011
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TotalNon Medical
IVD’s IVD’s MD’s
2,152 13 954 1,185No. of
cleared shipments
1,329,336,595 1,881,831 257,779,500 1,069,675,264Value of cleared items
TotalNon Medical
IVD’s IVD’s MD’s
119 1 89 29No. of
rejected shipments
10,025,343 36,376 6,070,741 3,918,226Value of rejected
items
Cleared shipment in 3rd quarter of 2011
Rejected shipment in 3rd quarter of 2011
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Cleared Shipment
2,988,422,269 SR
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Rejected Shipment
16,115,327 SR
Packing Problems
Labeling Problems
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Thank you