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Through the link below:
https://www.sfda.gov.sa/ar/medicaldevices/about/administration/pre-market_scientific_evaluation/standards/Pages/international-organization.aspx
For more infromation please contact regulation and standards section through the Email: md.standards@sfda.gov.sa
Opinion Stage "https://ideasbank.sfda.gov.sa" provieds a space for experts and public to participate and commentts ongoing drafts?
Opinion Stage "https://ideasbank.sfda.gov.sa" provieds a space for experts and public to participate and commentts ongoing drafts?
The countries can apply to lift the imposed ban through the diplomatic channels through the Saudi Ministry of Foreign Affairs or through the Saudi Embassy in the concerned countries or through the regulatory authority authorized by SFDA in these countries.
- products are classified through an electronic platform:
https://pcs.sfda.gov.sa/Default.En.aspx
- To create an account in product classification system (PCS):
https://www.youtube.com/watch?v=EI09W325Ybo
- To submit a new application:
https://www.youtube.com/watch?v=hx0Hn3EzV8I
- To appeal on the classification decision:
https://www.youtube.com/watch?v=X1QPhAaWp3k
The manufacturer is responsible for determining a device's classification using SFDA classification rules. The manufacturer needs to consider all applicable rules and classify the device based on the highest risk class. Additionally, the manufacturer must justify the chosen class/rule for both the device and any accessories.
You can reach the Guidance on Medical Devices Classification via:
https://sfda.gov.sa/sites/default/files/2020-03/MDS%E2%80%93G42.pdf
According to requirements and standards of the approved quality management system in the manufacturer.
AI is primarily spread by direct contact between healthy birds and infected birds, and through indirect contact with contaminated equipment and materials. The virus is excreted through the feces of infected birds and through secretions from the nose, mouth and eyes.
Contact with infected fecal material is the most common of bird-to-bird transmission. Wild ducks often introduce low pathogencicity into domestic flocks raised on range or in open flight pens through fecal contamination. Within a poultry house, transfer of the HPAI virus between birds can also occur via airborne secretions. The spread of avian influenza between poultry premises almost always follows the movement of contaminated people and equipment. AI also can be found on the outer surfaces of egg shells. Transfer of eggs is a potential means of AI transmission. Airborne transmission of virus from farm to farm is highly unlikely under usual circumstances.
HPAI can be spread from birds to people as a result of extensive direct contact with infected birds. Broad concerns about public health relate to the potential for the virus to mutate, or change into a form that could spread from person to person. The U.S. Department of Health and Human Services is aggressively working to ensure public health is protected. More information about the joint efforts of the federal government is available at www.pandemicflu.gov