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

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The Saudi Food and Drug Authority has withdrawn all “Care Plus” absorbent cotton products produced by CAREPLUS FOR MEDICAL INDUSTRIES, due to non-registration of the product.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

What is the deadline to do the payment fee of medical device marketing authorization (MDMA) when it is requested from Saudi Food and Drug authority?


Answer

The payment fee of MDMA must be done during 30 calendar days 


SFDA & Ministry of Interior (MOI), Observed some Radiology Deviations in 343 Healthcare Organizations

2015-07-28

SFDA & MOI specialist taskforce observed some deviations in radiology departments ( Diagnostic radiology, nuclear medicine and radiotherapy) in 314 healthcare organizations and 29 dental clinics in the different regions of the Kingdom during the field visits conducted to those organizations.

Other News

News List

Guidance on Innovative Medical Devices (MDS – G002)

2025-01-30
Guidance on Innovative Medical Devices (MDS – G002)
Guide
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Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives

2019-05-01
Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives
Guide
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MD Application Imaging Products Importation and Clearance

2019-03-02
MD Application Imaging Products Importation and Clearance
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