Medical Devices

Requirements for Unique Device Identification (UDI) for Medical Devices (MDS – REQ 7)

2022-06-16
Requirements for Unique Device Identification (UDI) for Medical Devices (MDS – REQ 7)
Requirement
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Requirements for Advertisement Approval and Launching Awareness and Charity Campaigns for Medical devices (MDS-REQ8)

2021-06-21
Requirements for Advertisement Approval and Launching Awareness and Charity Campaigns for Medical devices (MDS-REQ8)
Requirement
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National Diagnostic Reference Levels

2023-02-07
National Diagnostic Reference Levels
Blog
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Stop receiving marketing authorization application MDMA via GHTF route

Stop receiving marketing authorization application MDMA via GHTF route
Publication Date
Applying Date
2020-08-09

Requirements for Medical Devices Marketing Authorization (MDS-REQ 1)

2021-12-19
Requirements for Medical Devices Marketing Authorization (MDS-REQ 1)
Requirement
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Warning Date
    2020-07-08
Manufacture Country

Manufacture Company

The "SFDA" Issued a Field Safety Notice Regarding Use of "Non-Contact Forehead - Infrared Thermometer IM-9001"

2020-07-08

The Saudi Food and Drug Authority (SFDA) has issued a field safety corrective action about "non- contact forehead - Infrared Thermometer IM-9001" due to inaccurate temperature measurements.

The device is manufactured  by the Shenzhen Anbson Industries Co. Ltd.

  • To report sector-related issues

  • Call Centre 19999

Other Warnings

All Warnings

Warning Date
    2020-06-25
Manufacture Country

Manufacture Company

"SFDA" Issued a field safety notice on" OneTouch® Select Plus" Meter for Glucose Test Strips

2020-06-25

Saudi Food & Drug Authority (SFDA) has issued a field safety notice addressing a malfunction in a single batch of "OneTouch® Select Plus" glucose test strips, manufactured by LifeScan, GmbH,

The SFDA has explained that the defective test strip is (lot #4582205), this was because the meter repeats to request a blood sample without any test result.

  • To report sector-related issues

  • Call Centre 19999

Other Warnings

All Warnings

Requirements for Importation of Minimally Manipulated Biological Products Intended for Human Application

2022-01-31
Requirements for Importation of Minimally Manipulated Biological Products Intended for Human Application
Requirement
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Requirements for Clinical Trials of Medical Devices (MDS-REQ 2)

2023-12-19
Requirements for Clinical Trials of Medical Devices (MDS-REQ 2)
Requirement
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National Center for Medical Devices Reporting

National Center for Medical Devices Reporting ( NCMDR ) A systematic database to manage medical devices' post-market activities, such as Medical devices reporting of Adverse events and complaints, as well as publishing the Safety alerts of Medical devices with follow-up implementation of the corrective actions to ensure the safety, efficacy and performance of medical devices.

Service steps

  1. Enter to the link : https://ade.sfda.gov.sa/Home/NcmdrReport
  2. choose the Type of user,  as needed login
  3. Access the Reporting Service
  4. Fill out the form.
  5. Submit / Sending the Report

Conditions

To Enter as a Company you shall use Ghad Entry Details

Service requirements

Frequently asked questions

  • How to Report a complaint or adverse event?
  • Go to the steps of the service and follow it.

 

  • What should be reported?

 

  • Report of any event that leads or might lead to undesired or unexpected issues regarding safety of patients, users, janitors or any other person. This may include the following:

                    - Problems with the design of the device.
                   - Untrained or unaware staff.
                   - Carelessness in use.
                   - Uninstructed modifications.
                   - Inadequate maintenance.
                   - Inappropriate conditions: storage, temperature and use.

  • What actions will be taken by SFDA after receiving the reports?
  • The SFDA will review and verify the reports, and take the necessary actions to ensure the safety of medical devcies.

Target audience

Public / Medical Devices manufacturers / Authorized Representatives / Importer and Distributors / Healthcare providers

Service execution time

none

Service delivery channels

Digital Platform

Category

Cost

none

Call center

19999

Service guide

Guide

User's guide

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