Medical Devices

Question

What are the requirements of soft contact lenses (Cosmetic and or/ Correction Lens) and contact lenses solutions?


Answer

You can find guidance MDS-40 on: https://sfda.gov.sa/sites/default/files/2020-03/MDS-G40en.pdf


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.


Question

What are the required documents that need to be submitted to obtain the medical devices Marketing Authorization Certificate through the Technical File assessment (TFA) track?


Answer

For information about the technical documentation required to obtain TFA Marketing Permissions , please refer to MDS-G5- Guidance on Requirements for Medical Device Listing and Marketing Authorization: https://sfda.gov.sa/sites/default/files/2020-09/MDS-G5.pdf


Question

What is Unique Device Identification (UDI) for Medical Devices?


Answer

The UDI intends to unambiguously identify any medical device based on a globally accepted identification and coding standard that is accredited by regulatory bodies such as GS1, ICCBBA, HIBCC. You can visit Unique Device Identification (SAUDI-DI) system and viewing the frequently asked questions about the system through: https://udi.sfda.gov.sa/


Question

Is it allowed to combine and add more than a medical device or products in one medical device marketing authorization?


Answer

Yes, based on bundling/grouping criteria on guidance MDS-G7: https://sfda.gov.sa/sites/default/files/2021-01/%28MDS-G7%29ar_1.pdf


Question

What are the fees of marketing authorization application and how long does it take to issue?


Answer

You can reach to fees of marketing authorization application via: https://sfda.gov.sa/sites/default/files/2019-10/Fees-Rev-Times-Mark-Aut-App-ar%2Cen_9.pdf the marketing authorization will be issued during 35 business days as maximum if all requirements are fulfilled.


Question

"How medical devices classification must be performed"


Answer

The manufacturer is responsible for determining a device's classification using SFDA classification rules. The manufacturer needs to consider all applicable rules and classify the device based on the highest risk class. Additionally, the manufacturer must justify the chosen class/rule for both the device and any accessories. You can reach the Guidance on Medical Devices Classification via: https://sfda.gov.sa/sites/default/files/2020-03/MDS%E2%80%93G42.pdf


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.

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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.

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News List

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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