Presentation on theme: "Presented By: Eng. Meshal A. Alamri Executive Director, Premarket Approval & Scientific Evaluation Medical Devices Sector - SFDA."— Presentation transcript:
Presented By: Eng. Meshal 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).
Who is responsible for completing the application? Local Manufacturers Authorized Representativesfor overseas manufacturers 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.
Can I import medical devices without having Marketing Authorization ?
What is the period of validity of MDMA? The validity of MDMA is: same UNLESS The same as that of the marketing authorization granted in the GHTF Founding Member jurisdiction UNLESS an open end a self-declaration process 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 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 SFDAs website.
Changes in the provided documents documentary evidence changes before the written medical device marketing authorization has expired shall write to the SFDA informing them of this fact. 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 SFDAs website.
Related documents: Medical Devices Interim Regulation (chapter Two & chapter Six) Implementing Rule on Marketing Authorization (MDS-IR6) Guidance on Marketing Authorization Procedures (MDS – G5) MDMA User Manual
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.
How To Enroll ?
To Fill the MDMA Application 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. Kindly make sure:
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:
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
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.
For More Info. Kindly: 1- See the related documents available on the SFDA Website. 2- Send an inquiry to : 3- contact us for one-to-one meeting with SFDA Team.