Medical Devices

Requirements for Clearance of Medicines, Pharmaceutical Preparations, Medical Devices , Medical Supplies and Food Supplies for the Use of Pilgrims

2025-02-20
Requirements for Clearance of Medicines, Pharmaceutical Preparations, Medical Devices , Medical Supplies and Food Supplies for the Use of Pilgrims
Procedural rule
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Extending of work procedures for Medical Device Marketing Authorization (MDMA) requests until the medical device law comes into effect

Extending of work procedures for Medical Device Marketing Authorization (MDMA) requests until the medical device law comes into effect
Publication Date
Applying Date
2021-04-01
Warning Date
    2021-04-11
Manufacture Company

“SFDA” Withdraws “Care Plus” Medical Cotton

2021-04-11

The Saudi Food and Drug Authority has withdrawn all “Care Plus” absorbent cotton products produced by CAREPLUS FOR MEDICAL INDUSTRIES, due to non-registration of the product.

It is required to register the product in the SFDA to ensure its conformity and safety.

  • To report sector-related issues

  • Call Centre 19999

Other Warnings

All Warnings

Question

How to update the responsible person information in the radiation emitting medical devices assessment report?


Answer

Contact the radiological health executive administration via this e-mail: rh.md@sfda.gov.sa


Question

What are the requirements of evaluating the safe use of radiation emitting medical devices in healthcare facilities?


Answer

"You can find the requirements and guidance through this link  https://www.sfda.gov.sa/sites/default/files/2021-03/RequirementRadiationProtectionSafetyE.pdf


Question

"What are the importation and clearance requirements for medical imaging products? "


Answer

The importation and clearance requirement is being updated and it will be published soon.


Question

What are Medical Imaging products?


Answer

They are non-radioactive pharmaceutical products or products used in radioscopy, and SFDA approval is required for importing


Question

Is there a fixed Percentage of Saudization of jobs for whom request to be a service provider for Quality Assurance and Radiation Measurements?


Answer

thers is no fixed percentage, however, each company shall have A Saudi RSO, specialists, and experts as well


Question

What is the Validity of Quality Assurance and radiation measurements service provider license?


Answer

The  liscince is valid for 3 years starting from issue date 


Question

What is the process to submit a request for being service provider of Quality Assurance and Radiation measurements?


Answer

by submit the request through SFDA administration communcation system to Establishment License Department in Operation Sector 


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