Transcript MDMA:

Presented By:
Eng. Mesha’l A. Alamri
Executive Director, Premarket Approval & Scientific Evaluation
Medical Devices Sector - SFDA
Definition of
the Medical Device?
Means any instrument, apparatus, implement,
machine, appliance, implant, in vitro reagent or
calibrator, software, material or other similar or
related article:
Medical Device :
A. Intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific
purpose(s) of:
− Diagnosis, prevention, monitoring, treatment or alleviation of disease,
− Diagnosis, monitoring, treatment, alleviation of or compensation for an
injury or handicap,
− Investigation, replacement, modification, or support of the anatomy or
of a physiological process,
− Supporting or sustaining life,
− Control of conception,
− Disinfection of medical devices,
− Providing information for medical or diagnostic purposes by means of
in vitro examination of specimens derived from the human body.
Medical Device :
B. which does not achieve its primary intended action in or on
the human body by pharmacological, immunological or
metabolic means, but which may be assisted in its intended
function by such means.
Medical Devices Marketing Authorization
(MDMA):
Is an electronic system aims to authorize medical
devices after they comply with the Medical Devices
Interim Regulation (MDIR) and in particular to the
implementing rule MDS-IR6 for Medical Device
Marketing Authorisation (MDMA).
http://mdma.sfda.gov.sa/FAQs.aspx
Who is responsible for completing the
application?
The system allows Local Manufacturers and
Authorized Representatives for overseas
manufacturers to apply electronically for medical
devices marketing authorization which permits
relevant medical devices to be placed on the market
of Saudi Arabia.
What are the products that are required to obtain
SFDA - MDMA?
MDMA is required for the following products:
• All medical devices whatever their classification;
• Contact lenses for cosmetic as well as for medical
purposes; and
• Laser surgical equipment intended for cosmetic as
well as medical purposes.
From GUIDANCE ON MARKETING AUTHORIZATION PROCEDURES MDS - G5.
How much should I pay?
How long does the application take?
• Marketing Authorization application fees and review
time per classes were classified as follow:
Can I import medical devices
without having Marketing Authorization ?
From 14th of February 2011 medical devices that
have a SFDA marketing authorization maybe placed
on the market within the KSA.
After 14th of August 2011 only medical devices
that have a SFDA marketing authorization may be
placed on the market within the KSA.
After 31st of December 2011 only medical devices
that have a SFDA marketing authorization may be
put into service within the KSA.
What is the period of validity of
MDMA?
The validity of MDMA is:
The same as that of the marketing authorization
granted in the GHTF Founding Member jurisdiction
UNLESS
It has an open end, or Where the device has been
marketed through a self-declaration process (e.g.
Class I devices that are not sterile or having a
measuring function under EU regulations), MDMA
should be valid for 3 years.
Renewal or extension of marketing
authorization:
Sixty days before the written medical devices marketing
authorization expires, the local manufacturer or authorised
representative, as applicable, shall apply for its extension
using the electronic form found on the MDMA portion of
SFDA’s website.
Changes in the provided documents
If the documentary evidence provided to the SFDA with the
original MDMA application changes before the written
medical device marketing authorization has expired, the
local manufacturer or authorised representative, as
applicable, shall write to the SFDA informing them of this
fact. Subsequently, the SFDA shall require the updated
information to be provided using the electronic form found
on the MDMA portion of SFDA’s website.
Related documents:
• Medical Devices Interim Regulation (chapter Two & chapter Six)
http://www.sfda.gov.sa/NR/rdonlyres/7BF70791-912B-4DC0-AB7E-65CC929B002E/0/MedicalDevicesinterimregulation.pdf
• Implementing Rule on Marketing Authorization (MDS-IR6)
http://www.sfda.gov.sa/NR/rdonlyres/FE668808-A017-44BB-A7CB-EC1CF131196F/0/MDSIR6oct211.pdf
• Guidance on Marketing Authorization Procedures (MDS – G5)
http://www.sfda.gov.sa/NR/rdonlyres/A0CF63A9-452C-4AA4-95EA-B8AD8AC4B924/0/MDSG5oct211.pdf
• MDMA User Manual
http://www.sfda.gov.sa/NR/rdonlyres/4E6D59F4-C0DD-4131-A21F-7A50D9FF53CD/0/ApplicantUserManualMDMAV101.pdf
How To Enroll ?
First:
The applicant must be licensed as Authorized Representative
(AR) and hold MDEL Authorized Representative License for
each overseas manufacturer falling under his
responsibility, or valid MDNR number in case of Local
Manufacturer.
Second:
The applicant can access MDMA by using MDNR username
and password.
More information will be available in the MDMA user manual.
http://www.sfda.gov.sa/NR/rdonlyres/4E6D59F4-C0DD-4131-A21F-7A50D9FF53CD/0/ApplicantUserManualMDMAV101.pdf
How To Enroll ?
To Fill the MDMA Application
Kindly make sure:
1- You upload the related documents for the desired jurisdiction.
2- You upload ALL the required documents.
3- You upload VALID certificates/ Approvals.
4- You select the right CLASS & Category related to the desired Jurisdiction.
5- ALL the uploaded documents are in ENGLISH Language. Additionally, if the
device is for use by a lay person, labeling shall be in both Arabic and
English languages.
6- You write the name of products & Manufacturer Correctly, in order to be
printed on the MDMA Authorisation.
Filling the Application
Filling the application
 Manufacturer Details (Name & Site ).
 Medical Device Category.
Filling the application
Details of medical devices.
Label(s) & Instructions for use.
Information about A/C power supply &
environmental factors.
Advertising and marketing material.
Filling the application
Desired Jurisdiction.
• Australia.
• Canada .
• Europe .
• Japan.
• USA
Filling the application
Device Type & Classification.
Filling the application
Certificate/ Notification (ex: CE Certificate, FDA
510K).
Auditing Report.
Declaration of Conformity (DOC).
 Evidence for registration (Class I or General
IVD).
Filling the application
 QMS Certificate (ex: ISO 13485, FDA 21 CFR
820) & Reports.
Filling the application
 Attestation for completing the application.
Signature of the applicant.
The Required Approvals/
Certificates from Each
Jurisdiction:
Europe
The Required Approvals/
Certificates from Each
Jurisdiction:
USA
The Required Approvals/
Certificates from Each
Jurisdiction:
Canada
The Required Approvals/
Certificates from Each
Jurisdiction:
Japan
The Required Approvals/
Certificates from Each
Jurisdiction:
Australia
The Required Approvals/
Certificates from Each
Jurisdiction:
MDMA Certificate
MDMA Certificate
 When satisfied, the SFDA shall issue a written marketing authorization, in
both Arabic and English.
 It will indicate:
• the details of the manufacturer,
• sufficient information to identify the medical devices
• the period of its validity.
 The Authorization remains the property of the legal manufacturer, whether
local or overseas, and not of an authorized representative or importer.
MDMA Certificate
MDMA Certificate
For More Info.
Kindly:
1- See the related documents available on the SFDA Website.
2- Send an inquiry to : [email protected].
3- contact us for one-to-one meeting with SFDA Team.
Thank you