Transcript Authorised Representative Licensing

Authorised Representative Licensing
Presented By: Eng. Abdullah S. Al Dobaib
Registration and Licensing Executive Department ,MDS
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4/8/2015 6:32 AM
MDS Roadmap
MDNR
Number
IMPORTER
AR
MDNR
AR
application
Importer
&distributer
application
E. License
MDEL
MDMA
Market
Authorizati
on
DISTRBUTER
AR
Local Manuf.
Authorised Representative Licensing
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4/8/2015 6:32 AM
Authorized Representative Documents updated version
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Authorised Representative (AR)
Definition:
• Authorised Representative (AR):
means any natural or legal person established within the KSA who has
received a written mandate from the manufacturer to act on his behalf for
specified tasks including the obligation to represent the manufacturer in its
dealings with the SFDA.
(Article 1, Chapter 1, MDIR)
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General Principles
• When the manufacturer is located outside the KSA he shall appoint an
authorised representative to act on his behalf. (Article 11, MDIR)
• Chapter Six of the Medical Devices Interim Regulation requires organisations
authorised by a manufacturer to act on his behalf in the KSA to have an
establishment license for this activity, issued by the SFDA. (Article 4A, MDS-IR 5)
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Activities to be performed by an AR
Part I: Pre-License Activities
 Designation of Authorized Representatives
 Applying for establishment registration
 Mandate between the manufacturer and Authorized Representative
Part II: Applying for a License
Applying for establishment Licensing
Part III: Post-License Activities of Authorized Representatives
 Medical Device Marketing Authorization – General Provisions
 Post-Marketing Responsibility for Advertising and Marketing Material
 Post-Marketing Surveillance of Medical Devices
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Part I: Pre-License Activities
 Designation of Authorized Representatives
A.
The mandate established between the manufacturer and the authorized
representative shall be in writing, specify the mandated activities and be subject
to the laws of the KSA.
(Article 6 A, MDS-IR 5)
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Part I: Pre-License Activities
Mandate between the manufacturer and Authorized Representative
Single Site and Multiple sites
•
•
Two Samples agreement developed in Guidance 3
I, the undersigned, as party to this agreement, have the authority to agree on
behalf of the manufacturers listed below, for them to take without delay all
measures necessary to allow the execution of the tasks delegated to the
authorized representative. Moreover, I accept the commitment to ensure each
one of the listed manufacturers has a copy of this agreement and is aware of its
particular tasks and responsibilities under its provisions. ( multiple sites)
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Part I: Pre-License Activities
Mandate between the manufacturer and Authorized Representative
B. The minimum content of the contract (the ‘mandate’) between the
manufacturer and the authorized representative is specified in Article Six
of Implementing Rule MDS-IR5.
1) Represent the manufacturer in its dealings with the SFDA.
2) List each medical device category or generic device group intended to be supplied
to the KSA market.
3) Complete the marketing authorization application form.
4) Cooperate with the SFDA on evaluations and actions taken during market
surveillance and/or vigilance procedures.
5) Make any information available from the technical file to the SFDA when so
required.
(Article 6 B, MDS-IR 5)
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Part I: Pre-License Activities
Mandate between the manufacturer and Authorized Representative
6) Inform the SFDA of any adverse event that have occurred outside the KSA but
have consequences for medical device that have been authorized to be placed
on the KSA market.
7) Inform the SFDA of all field safety corrective actions resulting from post-market
follow-up investigations performed by the manufacturer .
8) Cooperate with parties involved in distribution activities, installation and
maintenance of medical devices that have been placed on the KSA market
under its mandate.
(Article 6 B, MDS-IR 5)
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Part I: Pre-License Activities
Mandate between the manufacturer and Authorized Representative
Medical Device Category or Generic Device Group
C. Where a manufacturer intends to make available more than one category or
generic device group of medical device to the KSA, it may either designate a
single authorized representative for all the devices it intends to market, or
designate a different authorized representative for each device category or
generic device group.
(Article 6 B, MDS-IR 5)
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Part I: Pre-License Activities
Mandate between the manufacturer and Authorized Representative
Medical Device Category or Generic Device Group
•
•
Device category :
Is the broadest level of medical device
nomenclature.
Category
Category
Active implantable devices
Reusable devices
Anesthetic and respiratory devices
Single-use devices
Dental devices
Assistive products for persons with disability
Electro mechanical medical devices
Diagnostic and therapeutic radiation devices
Hospital hardware
Complementary therapy devices
In vitro diagnostic devices
Biologically-derived devices
Non-active implantable devices
Healthcare facility products and adaptations
Ophthalmic and optical devices
Laboratory equipment
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.
Device
Category
Generic
device
group
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Part I: Pre-License Activities
Mandate between the manufacturer and Authorized Representative
Medical Device Category or Generic Device Group
I, the undersigned, declare that I have not designated any authorized
representative other than that who is party to this agreement to act on
my behalf for the medical devices listed in Section F.
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Part I: Pre-License Activities
Mandate between the manufacturer and Authorized Representative
 Other tasks and provisions
• Other Tasks and Provisions Additional to those
Required for Authorized Representative Licensing
are not assessed by the SFDA when it licenses the
authorized representative.
• AR will be Acting on behalf of the Manufacturer
for the medical device within the KSA according
to the AR agreement with the exception to the
paragraph pertaining aadditional tasks and
Provisions
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Other activities
E. Where the Authorized
Representative is also involved in
importation or distribution activities
of medical devices within the KSA, it
is subject to the additional
requirements and responsibilities
(MDS – IR4 Establishment Licensing)
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Part I: Pre-License Activities
D. The authorized representative shall have separate mandate and license for each
manufacturer it represents within the KSA.
License
Authorized
representative
License
License
(Article 5 C, MDS-IR 5)
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Requirements
1.
A copy of the mandates.
2.
Copies of the procedures that support each of the activities specified in the
manufacturer’s mandate .
3.
Application fees , 5200 SR for each mandate , to be paid through SADAD system.
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Part II: Applying for a License
Applications for Medical Devices Systems can be applied online
through The Medical Device Electronic Services .
1st. Apply for Establishment registration and obtain MDNR number
through MDNR system.
2nd. Apply for Authorized Representative license online through
MDEL system.
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MDNR
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
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Online application
The AR Application consists of
Three Main sections:
Section A: Company Details
Section B: Authorized Contact Person
Section C: Manufacturer and device categories
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Please note that sections A and
B will be retrieved from
the MDNR.
Section C :
1.Add Manufacturer
2.Save the application
3. Add device category
NOTE :
To add sub sites
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Please note that sections A and
B will be retrieved from the
MDNR.
Section C :
1.Add Manufacturer
2.Save the application
3. Add device category
4. attestation
5.Sumbission
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Payment
1.
2.
3.
5200 for each mandate.
Though SADAD system.
One month period to proceed with the payment
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Application cycle
Renewal
New
application
expired
Saved
Submission
One year
licensed
Under study
Issuing
Assessment
( 20 working days)
Open
Paid
Closed
Wait for
payment
Rejected
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Through SADAD
Establishment license
Only an authorised representative holding a valid establishment license, issued by
the SFDA, is permitted to legally act on behalf of the manufacturer in relation to the
relevant provisions of the Medical Device Interim Regulation and the corresponding
Implementing Rules.
License
Annexes
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Part III: Post-License Activities of Authorized Representatives
 Medical Device Marketing Authorization
(MDS – IR6 Marketing Authorization)
 Post-Marketing Responsibility for Advertising and Marketing Material

The overseas manufacturer through its authorized representative is responsible for
ensuring all advertising and marketing materials are approved by the SFDA before they are
used.
(II. Advertising, Article 39, Chapter 10, MDIR)
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Part III: Post-License Activities of Authorized Representatives
 Post-Marketing Surveillance of Medical Devices
–
Cooperate with the SFDA on evaluations and actions taken during Post-marketing
surveillance (MDS – IR7 Postmarking 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.
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Termination
Authorized representative is expected
to continue with the mandated tasks
until such time as the SFDA licenses an
alternative authorised representative to
represent the manufacturer within the
KSA.
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Security and Confidentiality of Data
• All data submitted online will be protected and
encrypted via the MDEL security infrastructure.
• All data provided will be used by SFDA.
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The Validity of a License
• The issued license has a validity of One year.
• The system automatically generates notification
•
for renewal
through the email to the
establishment 30 days before the license end.
Any changes to the provided information has to
be submitted to SFDA within 10 days of the date
of the change occur.
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Refusal of an Establishment License
A. The SFDA shall refuse to issue a license for an authorized representative if the mandated tasks
and/or the proposed procedures are insufficient to ensure the proper implementation of the
Medical Device Interim Regulation and this Implementation Rule. (Article 9A, MDS-IR 5)
B. If the SFDA intends to refuse the license, it shall notify the applicant in writing of the reasons of
the refusal and information of the procedure to appeal the action taken. (Article 9B, MDS-IR 5)
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Suspension of an issued license
A. The SFDA shall suspend the license of an authorized
representative if it has reasonable grounds to believe
that the licensee has contravened any of the relevant
provisions of the Medical Devices Interim Regulation, or
of the Implementing Rule 5 , or has made a false or
misleading statement in its application. (Article 10A,
MDS-IR 5)
B. The SFDA shall suspend the license of an authorised
representative if it is of the view that he has not
correctly fulfilled the mandates tasks. (Article 10A,
MDS-IR 5)
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Corrective action
1. Before suspending a license, the SFDA shall send the licensee a notice that sets out the
reason for the intended suspension and, if appropriate, corrective actions to be taken as
well as the time during which they shall be implemented. (Article 10C, MDS-IR 5)
2. The suspended license shall be reinstated if the situation that gave rise to its suspension
has been properly corrected. (Article 10D, MDS-IR 5)
3. If the required corrective actions have not been adopted in due time, the license shall be
withdrawn. (Article 10E, MDS-IR 5)
4. The SFDA shall provide information to the licensee on the procedure to appeal the
action taken. (Article 10F, MDS-IR 5)
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