Medical Devices

Agreement between a single legal manufacturer and an authorized representative

2023-02-16
Agreement between a single legal manufacturer and an authorized representative
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Updates on the compliance timeframe for the requirements of medical devices unique device identification (Saudi -DI)

Updates on the compliance timeframe for the requirements of medical devices unique device identification (Saudi -DI)
Publication Date
Applying Date
2021-08-18

Updating the requirements for approval of advertising for medical devices and fees

Updating the requirements for approval of advertising for medical devices and fees
Publication Date
Applying Date
2021-06-23

Regulations and Requirements for the clearance of medicines, pharmaceutical products, medical devices, and food products that arrive for pilgrims use

2024-04-29
Regulations and Requirements for the clearance of medicines, pharmaceutical products, medical devices, and food products that arrive for pilgrims use
Guide
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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The Saudi Food and Drug Authority has withdrawn all “Care Plus” absorbent cotton products produced by CAREPLUS FOR MEDICAL INDUSTRIES, due to non-registration of the product.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


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