Medical Devices

SFDA participates in International Conference on Radiation Medicine

2022-02-16

The Saudi Food and Drug Authority (SFDA) participated in the 7th Virtual International Conference on Radiation Medicine, organized by King Faisal Specialist Hospital and Research Center under the slogan "Clinical Applications and Innovative Approaches", during the period from 14 to 17 February 2022.

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Requirements for Safe Use of Medical Devices Inside Healthcare Facilities (MDS-REQ 3)

2023-07-25
Requirements for Safe Use of Medical Devices Inside Healthcare Facilities (MDS-REQ 3)
Requirement
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Innovative Medical Device Summary Form

2021-12-13
Innovative Medical Device Summary Form
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Declaration of Conformity (DOC) to “Medical Devices Law” and its Executive Regulation

2021-12-13
Declaration of Conformity (DOC) to “Medical Devices Law” and its Executive Regulation
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KSA to Host Meeting of Global Harmonization Working Party (GHWP) of Medical Devices

2021-11-29

The Saudi Food and Drug Authority (SFDA), an affiliate of the Kingdom of Saudi Arabia, is set to organize the 25th annual two-day meeting of the Global Harmonization Working Party (GHWP) of Medical Devices, via video conference, on Tuesday, it was reported today.

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Optical products requirements for registration

Optical products requirements for registration
Publication Date
Applying Date
2020-01-01

Agreement between an organization representing multiple legal manufacturers within a single company and an authorized representative

2023-02-16
Agreement between an organization representing multiple legal manufacturers within a single company and an authorized representative
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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
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