Organization : Saudi Food & Drug Authority
Type of Facility : Medical Devices Marketing Authorisation
Country: Saudi Arabia
Website : https://www.sfda.gov.sa/en
Medical Devices Marketing Authorisation :
Saudi Food and Drug Authority (SFDA) was established under the Council of Ministers resolution no. (1) Issued on 10/3/2003, as an independent Authority reporting to the Council of Ministers.
Related : Saudi Food & Drug Authority Pharmacovigilance Electronic Reporting Service : www.statusin.org/10091.html
The SFDA aims to “ensure the safety of food, safety, quality and effectiveness of drug, and the safety, quality, effectiveness and performance of medical devices according to their intended purpose. Regulating medical devices, in vitro- diagnostic devices, prescription eye glasses, contact lenses and their solutions, are among the responsibilities of SFDA in accordance with its law issued by the royal decree No.(M/6) issued on 13/2/2007.
Based on the Council of Ministers resolution no. (181) issued on 18/6/2007, that gave SFDA the right to issue regulations for medical devices registration rules and procedures, the SFDA issued a medical devices interim regulation, which was adopted by SFDA board of director’s decision no. (1-8-1429) issued on 27/12/2008. This regulation will apply until the medical devices comprehensive law is approved.
As a result the SFDA launched a comprehensive marketing authorisation program intended to safeguard public health as it relates to medical devices.
The program comprises two major steps:
1.** Establish an overall profile of the medical devices presently on the Kingdom of Saudi Arabia (KSA) market.
2.** Develop, adopt and apply a Medical Devices Interim Regulation, complemented by Implementing Rules, thereby ensuring legal certainty that only medical devices that have been authorised by one of the Founding Members of the Global Harmonization Task Force (GHTF) have access to the KSA market.
In fulfillment of Medical Devices Interim Regulation (chapter Two & chapter Six) in addition to Implementing Rule on the Validation of Documents to be provided to the SFDA by Manufacturers for Marketing Authorisation (MDS-IR6), The SFDA is pleased to lunch Medical Devices marketing Authorization System (MDMA).
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). The system allows local manufacturers and overseas manufacturers authorized representatives to apply electronically for medical devices marketing authorization which permits relevant medical devices to be placed on the market of the Kingdom of Saudi Arabia, when satisfied that the applicant has provided all the required information for market authorization.
FAQs:
1. What is a medical device ?:
‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:
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;
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.
2. What does Authorised Representative (AR) mean?:
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.
3. What does placing on the market mean?:
Placing on the market: means the first making available in return for payment or free of charge of a medical device, with a view to distribution and/or use within the KSA, regardless of whether it is new or fully refurbished.
4. Who Should Apply for Marketing Authorization?:
Medical device marketing authorization applications shall be made to the SFDA by either :
** a local manufacturer or,
** where the manufacturer is established outside the KSA, by its authorised representative.
5. How To Enroll ?:
Prior to applying for MDMA application, the applicant must be licensed as Authorized Representative and hold MDEL Authorized Representative for each foreign manufacturer falling under his responsibility, or valid MDNR number in case of Local Manufacturer. The applicant can use the username and password of (MDNR) Account to logon into the MDMA system.
6. What are the products that required SFDA Medical Devices Marketing Authorization?:
The MDMA required for the following products:
** All Medical Devices and their accessories that will be supplied to the KSA market.
** Contact lenses and laser equipment for cosmetic rather than medical purposes and their accessories.
7. 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.
8. What is the period of validity of MDMA?:
The end date of the period of validity will be the same as that of the marketing authorization granted in the GHTF Founding Member jurisdiction unless the GHTF Founding Member’s authorization is open ended and does not indicate a validity end-date, 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), where validity shall be 3 years.