mdc.sfda.gov.sa Medical Device Classification System : Saudi Food & Drug Authority

Organization : Saudi Food & Drug Authority
Type of Facility : Medical Device Classification System
Country: Saudi Arabia

Website : http://mdc.sfda.gov.sa/Default.En.aspx

Medical Device Classification System :

MDC SYSTEM is an online classification system to help the applicant in classification of the product whether it’s fall under medical device responsibilities or not.

Related : Saudi Food & Drug Authority National Center For Medical Devices Reporting : www.statusin.org/10100.html

In accordance with the Food and Drug Authority(SFDA) law issued by the royal decree (M/6) on the 25/ 01/1428 which gave the Saudi Food and Drug Authority the responsibility to regulate medical devices in Saudi Arabia.

The council of ministers decision No.181 issued on 3/6/1428 came to stress the importance of regulating medical devices which relate directly to human health. In the last few years, the Saudi health services have grown tremendously.

There are over 390 hospitals occupying more than 54,000 beds, 2037 primary healthcare centers, 175 artificial kidney centers and approximately 217 private medical centers.

As well as , an increased, number of newly opened hospitals and health centers both in the public and the private sector. In consequently, the Saudi Arabian medical devices market is growing rapidly, thus, the presence of a regulatory body is important to ensure safety, quality and effectiveness of medical devices throughout their life cycle (pre-market, on-market and post-market).

The main objectives of the Medical Devices Sector (MDS) at SFDA are to protect and maintain public health within the Kingdom of Saudi Arabia (KSA) by the implementation of provisions ensuring a high level of safety and health protection of patients, users and third parties with regard to the use of medical devices as it relates to their manufacture, supply and use during their lifecycle and to mandate measures, and allocate responsibilities, to ensure that medical devices placed on the market and/or put into service within the KSA comply with all relevant requirements and provisions of the Saudi Food and Drug Authority according to the Medical devices Interim Regulation and its implementing rules.

Out of e-transformation procedures and regulations of the Saudi Food & Drug Authority, Medical Device Sector is pleased to announce the launch of Medical Device Classification (MDS) system.

Frequently Asked Questions:

What is the 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:

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 e.g. disinfection substances , etc

** inves­tigation, replacement, modification, or support of the anatomy or of a physiologi­cal process e.g. prescription eye glasses , aids for disabled/handicapped people, etc
** 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;

** and 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.

Why to classify ?:
To determine whether the product fall in medical device responsibilities or not.

Who need to classify ?:
Medical device establishments located in the Kingdom of Saudi Arabia. Manufacturers, Importers, Distributors who need help to determine if the product medical device or not.

How To Enrol?:
1.Enrol on-line through the SFDA website .sfda.gov.sa
2.Click on “Medical Devices”
3.Click on the Medical Device Electronic Services MDES link
4.Click on the MDC link