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not comply with the relevant provisions of the Medical Devices Interim Regulation and its Implementing Rules, is either withdrawn from the market, or subject to appropriate corrective action to eradicate the non-compliance.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