Compliance

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Compliance Enforcement

• Updates

Abdullah Alrasheed Compliance Enforcement Dept.
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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  either withdrawn from the market, or subject to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
Importing
Packaging Labelling
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

• University
• Manufacturers
• Hospitals

• Manufacturers

• Importers
• Distributors
• Authorized Representative

• Manufacturers
• Importers
• Distributors
• Authorized Representative

• Patients
• Healthcare Providers

• Patients
• Healthcare Providers
• Establishments.

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Approach
Inspection
Enforce.
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Total Number of Inspected Establishments2010 -
2011
Up to Nov 23, 2011
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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.

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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.
•  
•  

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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.

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High level establishment inspection process map
Requester
Document review section
Inspectors
Establishment

• -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
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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
Communicate findings to establishment and request
a Corrective Action Plan
Receive inspection findings
Compliance Assessment Department
Submit Corrective Action Plan to SFDA
Establishment
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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
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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.

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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.
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Flow Chart of ECP
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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.

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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 Entry

• Medical Devices are inspected at the following
  ports of entry

Code Port Region
RDP Dry Port Riyadh
RAP King Khaled international airport Riyadh
JAP King Abdul-Aziz international airport Jeddah
JSP Jeddah Islamic sea port Jeddah
DAP King Fahad international airport Dammam
DCP King Fahad causeway Dammam
DSP King Abdul-Aziz sea port Dammam
BBP Batha port, UAE border Al-Batha
HBP Haditha port, Jordan border Quariat
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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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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.

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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.

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Cleared shipment in 2010
Total Non Medical IVDs IVDs MDs
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
Total Non Medical IVDs IVDs MDs
546 1 419 126 No. of rejected shipments
20,318,454 20,593 12,864,011 7,433,850 Value of rejected items
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Cleared shipment in 1st quarter of 2011
Total Non Medical IVDs IVDs MDs
2,432 7 1,171 1,254 No. of cleared shipments
714,544,991 912,064 317,945,934 395,686,993 Value of cleared items
Rejected shipment in 1st quarter of 2011
Total Non Medical IVDs IVDs MDs
104 0 84 20 No. of rejected shipments
2,968,501 0 2,164,887 803,614 Value of rejected items
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Cleared shipment in 2nd quarter of 2011
Total Non Medical IVDs IVDs MDs
2,625 20 1,148 1,457 No. of cleared shipments
944,540,683 3,148,929 429,676,126 511,715,628 Value of cleared items
Rejected shipment in 2nd quarter of 2011
Total Non Medical IVDs IVDs MDs
91 0 74 17 No. of rejected shipments
3,121,483 0 2,041,493 1,079,990 Value of rejected items
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Cleared shipment in 3rd quarter of 2011
Total Non Medical IVDs IVDs MDs
2,152 13 954 1,185 No. of cleared shipments
1,329,336,595 1,881,831 257,779,500 1,069,675,264 Value of cleared items
Rejected shipment in 3rd quarter of 2011
Total Non Medical IVDs IVDs MDs
119 1 89 29 No. of rejected shipments
10,025,343 36,376 6,070,741 3,918,226 Value of rejected items
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Cleared Shipment
2,988,422,269 SR
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Rejected Shipment
16,115,327 SR
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Packing Problems
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Labeling Problems
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• Thank you