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

2015-05-26

 

 

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: "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 ". 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.





Medical Devices