"SFDA" launches classification system for medical devices and products (MDC)

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<p class="ms-rteElement-P" style="text-align:justify">SFDA launched classification for medical devices and
products system (MDC), which aims to facilitate and accelerate the procedures
in categorization received transactions for medical devices and products
sector, as well as link relevant authorities electronically, between different
sectors of SFDA and its subsidiaries customs and ports and other government
agencies, and suppliers and distributors and corporate medical devices, as the
system works to benefit the susceptibility of product within the terms of
reference for hardware sector and medical products or not, and that includes
the following products: (Medical Devices - Medical chemicals - hardware
diagnostic laboratory, medical and non-medical - materials and products
radiological devices - and visual products - Dentistry devices and products -
Distillation devices, etc), in addition to products classification based on the
special supervision of medical devices regulation, and to facilitate tracking
the transaction through the electronic system procedures, along with a
databases by classification request of medical and non-medical devices.
Abdullah Al-Dhbaib Deputy President Executive sector medical devices in SFDA
confirmed that SFDA services are offered electronically through its website
easily and conveniently to applicants, without the need to attend to SFDA and
provide papers, pointing out that main goal is to be the main trading without
papers with the orientations of Kingdom in the application of e-government, said:
&quot;This is one of SFDA strategies, the electronic transformation, and based
on that electronic services were established for all-sector and the systems now
are working on the website, the remaining now is the classification system,
which is not clear for a lot of companies through product classification for
medical devices, and we have mandatory plan banned every medical device to
enter the Saudi market unless it's only authorized by SFDA, where SFDA
developed a plan and announced on the website during the last period based on the
seriousness of the devices, and we started high-risk devices that have impact
leads to the death of the patient, God forbid, the medium-risk and low ones are
subject to the conditions and standards, and our goal will be by the end of
year 2015 that all medical devices will not enter the Saudi market, only the
approved and expressly authorized by SFDA in all categories &quot;. Al-Dhubaib
said: applications for licensing medical devices numbering for past year was
2800 requests, while since the beginning of the current year and after
implementation on electronic application until the end of September has been
receiving nearly 6000 requests, noting that the new procedure makes it easier
for beneficiaries and applicants to communicate with SFDA and customs so that the
transaction take its course until the issuance of the approval.<span lang="AR-SA" dir="RTL"></p>
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