Role of Overseas manufacturers

authorized representatives
Presented By: Eng. Nawaf N. Albarakah

Content
Introduction.
Authorized Representative Role.
Pre-Market
On-Market
Post-Market
SFDA experience.
AR Online licensing system.

Introduction
What?
A legal entity designated by the overseas manufacturer to represent it with
regulatory authority in the desired country.

Who?

Importer.

Distributor.

Scientific office.

Legal Office.

Introduction Cont.
Authorities Names for an AR ?
US. Food and Drug Administration (FDA): US Agent.
European Commission (EU): Authorized Representative.
Therapeutic Goods Administration (TGA): Sponsor.

Ministry of Health, Labor and Welfare (MHLW): Market Authorization Holder (MAH).
Saudi Food and Drug Authority (SFDA): Authorized Representative

Authorised Representative Role

o Pre-market.
o On-market.
o Post-market.

Authorised Representative Role

Pre Market Activities :
Manufacturers shall designate an authorized representative for their medical
devices.

Authorized representative act as primary contact.

Authorized representative shall be established in the competent authority
country.

A written agreement between the manufacturer and Authorized

Representative shall be possessed that sets the terms and conditions of the
appointment.

Authorised Representative Role

On Market Activities :
Representing the manufacturer.
Responding to questions concerning the overseas manufacturer medical
devices.
Maintain the documentation which has been used to demonstrate compliance
with the Regulation.

Authorised Representative Role

Post Market Activities:
Inform the authority of any adverse events of represented medical devices.
Inform the authority of all field safety corrective actions.
Inform the authority of any Recalls.

SFDA Experience in AR
Authorised Representative (AR)

Interim Regulation: Chapters 4 & 6

Implementing Rules: IR5
Guidance MDS-G3
When the manufacturer is located outside the KSA he shall appoint
an authorised representative to act on his behalf.

The authorised representative shall:

Register their establishment (MDNR).

Obtain an AR License (MDEL).
Submit the Market Authorisation application(MDMA).

SFDA Medical Device Regulations

Interim
Regulation
National

Provisions

Implementing Rules

Guidance Documents

Announcements

Force of Law

SFDA Experience in AR

An importer and/or distributor of medical devices may,

at the same time, act as an Authorised Representative.

If they are both an AR and an importer and/or

distributor they must apply for both an Establishment
License and the Authorised Representative License.

Authorised Representative License is on the MDEL

electronic system.

SFDA Experience in AR

The manufacturer shall provide a copy of

the written mandate that defines the
designated responsibilities of the Authorised
Representative

SFDA Experience in AR
The AR mandate IR5 Article 6:
Defines the
mandate

content

of

the

A sample of Authorised Representative

Agreements can be found in the SFDA
Guidance document MDS-G3. Also, in
the MDEL AR application webpage.

SFDA Experience in AR
The mandate shall, at a minimum, allow the authorised representative to:

1.
2.
3.
4.
5.

6.
7.
8.

Represent the manufacturer in its dealings with the SFDA.

List each medical device category intended to be supplied to the KSA market.
Complete the Marketing Authorisation on-line application form (MDMA).
Cooperate with the SFDA on evaluations and actions taken during market surveillance
and/or vigilance procedures.
Make information available to the SFDA when so required in relation to its market
surveillance activities.
Inform the SFDA of any incidents that have occurred outside the KSA.
Inform the SFDA of all field safety corrective actions resulting from post-market
surveillance.
Cooperate with parties involved in distribution activities, installation and maintenance
of medical devices that have been placed on the KSA market under its mandate.

SFDA Experience in AR
Manufacturer

AR

Dealing with SFDA

Complete MDMA

Post Market
Surveillance

Inform SFDA of
Incidents
Outside
KSA

Cooperate with
Importers
Distributors
Installation
Maintenance

SFDA Experience in AR
The Manufacturer may have different authorised representatives for
different category of devices or generic device group.
Medical Devices Categories

Device category :
Is the broadest level of medical
device nomenclature.

Generic device group:

means a set of devices having
the same or similar intended
uses or commonality of
technology allowing them to be
classified in a generic manner
not reflecting specific
characteristics.

Active Implantable Devices

Anaesthetic and Respiratory
Devices

Non-active Implantable Devices

Dental Devices

Complementary Therapy Devices

Electro Mechanical Medical

Devices
In Vitro Diagnostic Devices
Single-use Devices
Diagnostic and Therapeutic
Radiation Devices
Healthcare Facility Products and
Adaptations
Biologically Derived Devices

Medical Software

Other Categories

Ophthalmic and optical devices

Hospital Hardware
Reusable Devices
Assistive Products for Persons
with Disability
Laboratory Equipment

Device
Category

Generic
device
group

SFDA Experience in AR
The authorized representative shall have separate mandate and
license for each manufacturer it represents within the KSA.
License
Authorized
representative

License
License

Mandated tasks
Representation

Pos-market
activities

On-market
activities

Pre-market
activities

Documentation

How To Apply ?

Medical Device Establishment License (MDEL)

Applications for Medical Devices Systems can be applied online

through The Medical Device Sector Electronic Services .
1st. Apply for Establishment registration and obtain MDNR number
through MDNR system.

2nd. Apply for Authorized Representative license online through MDEL

system.

20

Medical Devices National Registry

In order to be able to access Authorised representative application through
MDEL system , you must select Authorised Representative as an establishment
type on MDNR system.

21

Medical Device Establishment License (MDEL)

Medical
Device
Establishment
License
(MDEL)

Authorised
Representative
License

Applying for AR License

Applying for AR License

Applying for AR License

Applying for AR License

Applying for AR License

The services consist

of two Applications :
1.

Importer/ Distributor Application

2.

AR Application

Applying for AR License

The services consist of 2

Applications :

Authorised Representative
Application

Applying for AR License

Company details and the

authorized contact person are
automatically retrieved from the
MDNR system

Applying for AR License

Manufacturer and device categories

Add manufacturer

Applying for AR License

Manufacturer and device categories

1. Add manufacturers details

2. Upload the Mandate

3. Save

Applying for AR License

Manufacturer and device categories

Add Manufacturers Device Category

Applying for AR License

Manufacturer and device categories

Device Category
(drop-down menu)
Save
Medical Devices Categories
Active Implantable Devices
Anaesthetic and Respiratory
Devices
Ophthalmic and optical devices
Hospital Hardware
Reusable Devices
Assistive Products for Persons
with Disability
Laboratory Equipment
Complementary Therapy
Devices
Medical Software

Non-active Implantable Devices

Dental Devices

Electro Mechanical Medical Devices

In Vitro Diagnostic Devices
Single-use Devices
Diagnostic and Therapeutic Radiation
Devices
Healthcare Facility Products and
Adaptations
Biologically Derived Devices
Other Categories

Applying for AR License

Manufacturer and device categories

Add Device Category & Save

Note: the ability to add Manufactures
Sub Sites

Applying for AR License

Manufacturer and device categories

Add sub site details

Applying for AR License

Manufacturer and device categories

Complete the Attestation and

tick the boxes,
then,
Submit the Application

Applying for AR License

Payment
The SFDA will calculate the fee
based on the number mandates
submitted by the Authorised
Representative.

AR Fees: SAR 5200 per Manufactures Mandate

SFDA Review: 20 working days

Application cycle
Renewal

New
application

expired

Saved
Submission

One year

licensed

Under study

Issuing

Assessment
( 20 working days)

Open
Paid
Closed

Accept \
Payment
Reject

Through SADAD

Licensed Authorised Representative

Authorised Representative License

The license will be issued to the applicant and the application status will be changed to
Licensed.
Valid for One year.

The Authorised Person will be notified by email 30 days before the license expires.
Any changes have to be submitted to SFDA within 10 days.

MDEL Statistics

MDEL - AR System has been lunched on 14th Feb 2011.

Licensed

Rejected

Understudy

Manufacturer

1911

265

180

AR

451

117

68

Manufacturers Applications
%9
%14
Licensed
Rejected
%77

Understudy

Thanks all