Medical Devices

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)

2025-06-22
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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Approval of technical and clinical specifications for medical radioactive materials

electronic system through which requests for approval of technical and clinical specifications for medical radioactive materials for the benefit of medical establishment are received which requested by importer, re-exporter and transporter establishments of these materials, and then approval of technical and clinical specifications is issued, before applying for importing or re-exporting clearance

Service steps

  1. Access the MRMR system through the link (mrmr.sfda.gov.sa)
  2. Create an account in the system according to the type (medical establishment, Importer/exporter establishment or carrier establishment)
  3. Submit an application for approval of technical and clinical specifications for the purpose of importing or re-exporting medical radioactive materials
  4. Submit the required documents
  5. If the requirements are met, a certificate of approval of technical and clinical specifications of medical radioactive materials will be issued.

Conditions

1- Valid Medica Devices Establishment License (MDEL) for importers and exporters of radioactive material. 2- Neccessary licenses to practice activities related to medical radioactive materials for the medical establishment and carrier establishment 3- Submit all the documents required to study the application

Service requirements

Frequently asked questions

  • What are the facilities targeted in the service ?    

        - Importers and exporters establishments
        - Carriers establishments
        - Medical establishmets
        - Medical Radioactive Material producers establishments

  • Is it required to pay a fee to open an account in the  system?

      -  No fees are required to open an account in the  system at the present time

  • Is there an expiration date for approval certificate ?

      -  Yes, the approval is valid for three months from the issuance date.

  • What are the medical radioactive materials that can be requested through the system?

      -  They are the medical radioactive materials licensed to the medical establishments in the practice license only, and in the same quantity and licensed activity.

  • When submitting an import or re-export application through the user, the name of the medical establishment does not appear in the list of beneficiary facilities?

      -  In order to show the name of the beneficiary facility, the medical establishemt shall register in the system, complete all requirements and obtain final approval of the application.

Target audience

Government Sector / Private Sector

Service execution time

6 working hours

Service delivery channels

Digital Platform

Category

Cost

None

Call center

19999

Service guide


User's guide


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Question

Does SFDA require corrective action for all reported incidents of medical devices and products?


Answer

Not necessarily, and regulatory bodies often take the manufacturer's recommendations into account in such cases, and it is not prohibited to add some requirements according to each case separately.  


Question

What are the obligations of importers and distributors regarding medical devices post-marketing?


Answer

Refer to SFDA requirements in this regard, as well as the following procedural rules and guidelines: • Implementing Rule for licensing facilities (MDS-IR4) https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/implementing_rules.aspx • Post-Marketing Control Implementing Rule (MDS-IR7) https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/implementing_rules.aspx • Relevant Guidance


Question

What is the timeframe for reporting adverse event, incident, and complaint?


Answer

Manufacturers, Authorized Representative, Importers, Distributors shall report to the SFDA, upon becoming aware that adverse event, incident, a complaint has occurred, as follows: − Not later than (2) working days from the date of awareness, if the adverse event, incident, and complaint represent a serious public health threat. − Not later than (10) working days from the date of awareness if the adverse event, incident, complaint that results in an unanticipated death or unanticipated serious injury. − Not later than (30) calendar days from the date of awareness for all adverse events, incidents, complaints which are not associated with high risks. − If SFDA initiate a report of adverse event, incident, complaint, the response shall be received within (5) working days.


Question

When should medical device adverse event, incident, and complaint be reported?


Answer

The local manufactures, the overseas manufactures, Authorized Representative, Importers, Distributors and the health practitioner must report incidents and adverse events to SFDA upon becoming aware it happens  


Question

Can I appeal to the rejection decision ?


Answer

The appeal process to rejected shipments is published at:  (Click here)  


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