Medical Devices

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

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
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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

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