Compliance & Enforcement
Updates
Abdullah Alrasheed
Compliance & Enforcement Dept.
Contents
•
•
•
•
•
Objectives
Product value chain
Requirements
Counterfeit MD
POEs
2
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Rules, is either withdrawn from the market, or subject to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
Medical Devices Life Cycle
Conception
and Design
Manufacture
Pre-market
Packaging
Labelling
Importing
Sale
Use
Disposal
On-market
Post-market
4
“Development to Disposal” Value
Chain
Description
Concept &
Developmen
t
 Design inputs
 Product is
leading to new
manufactured,
concept or newer
packaged &
version
labeled
 Testing (inc.
verification,
validation, &
clinical trials)
 University
Stakeholders
Manufacture
 Manufactur
ers
 Hospitals
Import
Distribution
 Product is
shipped from
its
manufacturing
site via land,
air or sea to
local
warehouse
 Manufacture  Importers
rs
 Product is
transferred
from local
warehouse to
healthcare
provider
 Marketing and
sale
Application
 Product is
operated or
used
Disposal
 Product is
removed after
reaching end
of its life cycle
 Manufacture  Patients
 Patients
rs
 Distributors
 Healthcare  Healthcare
 Importers
Providers
Providers
 Authorized
 Distributors
Represent
 Establishm
 Authorized
ative
ents.
Representati
ve
5
Approach
Est
.
Inspection
MD
Asses
Enforce.
POE
6
Total Number of Inspected Establishments
2010 - 2011
* Up to Nov 23, 2011
7
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.
9
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.
10
High level establishment inspection process map
Requester
Initiate a
request
Type of
Inspection
Document review
section
-Gather all require document (eg. Location
map , list of device and recall form).
-Communicate with Est. to complete all
missing document.
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
11
High level Establishment Compliance
Assessment process map
Close case
Compliance Assessment
Department
Establishment
Submit Corrective
Action Plan to
SFDA
Request followup inspection to
confirm
implementation
of corrective
actions
Communicate
findings to
establishment
and request a
Corrective
Action Plan
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
Receive and assess
follow-up inspection
findings
Request enforcement
actions if
establishment fails to
implement corrective
actions
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Non Compliances Risk Classification
Risk classification
Criteria

An observation describing a situation that poses or may
have the potential to result a tangible risk to public
health

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.
Sever
Moderate


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.
18
Medical Devices Anti- counterfeiting
19
Ports of Entry
Medical Devices are inspected at the following ports of entry:
Region
Port
Code
Dry Port
RDP
King Khaled international
airport
RAP
King Abdul-Aziz international
airport
JAP
Jeddah Islamic sea port
JSP
King Fahad international
airport
DAP
King Fahad causeway
DCP
King Abdul-Aziz sea port
DSP
Al-Batha
Batha port, UAE border
BBP
Quariat
Haditha port, Jordan border
HBP
Riyadh
Jeddah
Dammam
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.
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
No. of
cleared
shipments
Value of
cleared
items
MD’s
IVD’s
Non Medical
IVD’s
Total
9,343
4,024
34
13,401
3,248,083,701
927,624,944
18,699,006
4,194,407,651
Rejected shipment in 2010
No. of
rejected
shipments
Value of
rejected
items
MD’s
IVD’s
Non Medical
IVD’s
Total
126
419
1
546
7,433,850
12,864,011
20,593
20,318,454
24
Cleared shipment in 1st quarter of 2011
No. of
cleared
shipments
Value of
cleared
items
MD’s
IVD’s
Non Medical
IVD’s
Total
1,254
1,171
7
2,432
395,686,993
317,945,934
912,064
714,544,991
Rejected shipment in 1st quarter of 2011
No. of
rejected
shipments
Value of
rejected
items
MD’s
IVD’s
Non Medical
IVD’s
Total
20
84
0
104
803,614
2,164,887
0
2,968,501
25
Cleared shipment in 2nd quarter of 2011
No. of
cleared
shipments
Value of
cleared
items
MD’s
IVD’s
Non Medical
IVD’s
Total
1,457
1,148
20
2,625
511,715,628
429,676,126
3,148,929
944,540,683
Rejected shipment in 2nd quarter of 2011
No. of
rejected
shipments
Value of
rejected
items
MD’s
IVD’s
Non Medical
IVD’s
Total
17
74
0
91
1,079,990
2,041,493
0
3,121,483
26
Cleared shipment in 3rd quarter of 2011
No. of
cleared
shipments
Value of
cleared
items
MD’s
IVD’s
Non Medical
IVD’s
Total
1,185
954
13
2,152
1,069,675,264
257,779,500
1,881,831
1,329,336,595
Rejected shipment in 3rd quarter of 2011
No. of
rejected
shipments
Value of
rejected
items
MD’s
IVD’s
Non Medical
IVD’s
Total
29
89
1
119
3,918,226
6,070,741
36,376
10,025,343
27
Cleared Shipment
2,988,422,269 SR
28
Rejected Shipment
16,115,327 SR
29
Packing Problems
Labeling Problems
37
Thank you
38