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Question

Who can report?


Answer

Everyone can report: users, health practitioners, manufacturers, authorized representatives, suppliers or distributors.


Question

What does mean, “The timeframe for returned MDMA application is 60 calendar days” in announcement (8) 8/2019?


Answer

Means the total days of ALL 3 cycles is 60 days to fulfill all the requirements. In occasions where applicant have a valid justification to extend the response period for SFDA’s observations to more than 60 calendar days, such requests must be emailed to mdma.it@sfda.gov.sa.


Renewing the Saudi Arabia’s Chairmanship of the GHWP

2020-12-06

Saudi Arabia has been elected at the chair of the Global Harmonization Working Party (GHWP) of Medical Devices until 2021.


The chairmanship is renewed for the fourth year in a raw, under the Executive Vice Executive President for Medical Devices at Saudi Food and Drug Authority, Eng. Ali Al-Dalaan.
 
It comes as a continuation of the pioneering role that the Kingdom plays, represented by the Saudi Food and Drug Authority during its chairmanship of the organization, in the fields of legislation and regulations for medical devices.

Other News

Saudi Arabia Hold Meeting with the Leaders of NHWP/GHWP to Discuss Capacity Building and Competencies

2020-10-15

The Kingdom of Saudi Arabia, represented by the Saudi Food & Drug Authority (SFDA) and G20 Saudi Secretariat, hosted last Tuesday a virtual meeting with the leaders of the Global Harmonization Working Party (GHWP) of Medical Devices (scientific and technical groups), as a part of the activities of the international conferences program held on the sidelines of Saudi Arabia’s presidency of the G20.

Other News

Unique Device Identifications (Saudi-DI)

UDI system (Saudi- DI) aims to record and document the identifier codes for medical devices based on international standards. Device (DI) codes will help the users and stakeholders to recognize all information related to the device through registered UDI codes and labeled on the device package

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launching medical devices unique device identification (Saudi -DI) system and the Compliance timeframe

launching medical devices unique device identification (Saudi -DI) system and the Compliance timeframe
Publication Date
Applying Date
2020-09-10
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