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SFDA Issues Safety Alert on Sleep Apnea Medical Devices

Warning Date
    2022-03-15
Manufacture Country

Manufacture Company

Warning Reason
Correction Actions
Advices to Consumer

SFDA Issues Safety Alert on Sleep Apnea Medical Devices

2022-03-15

Saudi Food and Drug Authority (SFDA) has issued a safety alert on the continuous positive airway pressure (CPAP) devices for the treatment of sleep apnea, manufactured by Philips Respironics in the United States of America .

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

GHWP Leaders Decide to Support Less Regulated Countries to Increase their Medical Devices Efficiency

2022-03-09

The leaders of the Global Harmonization Working Party (GHWP) for Medical Devices decided to increase the number of participants from the regulatory bodies in the organization’s scientific and technical work groups. This came during the meeting of the organization’s general secretariat and leaders of scientific and technical groups, hosted virtually by the Kingdom of Saudi Arabia, which was represented by the Saudi Food and Drug Authority (SFDA), yesterday, March 8, 2022.

Other News

Saudi Arabia to Host the Global Harmonization Working Party  (GHWP)  TC leaders and Secretariat meeting

2022-03-07

The Kingdom of Saudi Arabia, represented by the Saudi Food and Drug Authority (SFDA), will host, virtually, tomorrow, Tuesday, March 8, 2022, the meeting of the General Secretariat of the Global Harmonization Working Party (GHWP) and leaders of scientific and technical work groups.

Other News

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.

Other News

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.

Other News

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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