FAQ

Share page

Filter By

Display 10 - 18 from 178

Beneficiaries
Category

if SFDA deems to  the necessity of conducting a study to evaluate the device, according to the frequency or severity of accidents, it may result in the addition of some conditions, which will inevitably be based on the methodology of risk analysis based on scientific foundations, and considering the best international practices.

It consider a medical device if its intended use meets any of the purpose(s) mentioned in the medical device definition, whether used separately or as part of a medical device.

• Do not move the medical device or its accessories unless it poses a danger to the patient or medical staff.
• Do not change the control settings for any medical device.
• Do not disconnect or dispose of any disposable or disposable accessories or parts such as wires, catheters, electrodes, tubes belonging to the medical device ... etc., as their presence is important in understanding the event.
• Adequate capture of photos.
• Document: who was there, who worked, what happened, etc.
• Report the event to SFDA.

  • Medical IVD's devices,
  • Medical IVD and non-Medical IVD’s. 
  • Chilled and frozen foods. 
  • Any shipment requires a specific temperature for transportation and/or storage, according to the manufacturer's instructions, shall contain data logger (digital temperature indicator) activated from the time of shipping.
     

The UDI intends to unambiguously identify any medical device based on a globally accepted identification and coding standard that is accredited by regulatory bodies such as GS1, ICCBBA, HIBCC.
You can visit Unique Device Identification (SAUDI-DI) system and viewing the frequently asked questions about the system through:
https://udi.sfda.gov.sa/

The  liscince is valid for 3 years starting from issue date 

Inspection of establishments (onsite or remote Inspection) can be done accordingly if the competent authority in the country sends a request through the diplomatic channels to the Saudi FDA specifying the establishment's details.

The USDA recommends three ways to defrost turkeys: in the refrigerator, in cold water and in the microwave. Never defrost turkey on the counter or in other locations.

  • It's best to plan ahead for slow, safe thawing in the refrigerator. Allow about 1 day for every 5 pounds of turkey to thaw in the refrigerator.
  • Turkey may be defrosted in cold water in its airtight packaging or in a leak-proof bag. Submerge the bird or cut-up parts in cold water, changing the water every 30 minutes.
  • Turkey defrosted in the microwave should be cooked immediately after thawing because some areas of the food may become warm and begin to cook during microwaving. Holding partially cooked food is not recommended because any bacteria present wouldn't have been destroyed.

If you purchase previously frozen meat, poultry or fish at a retail store, you can refreeze if it has been handled properly. 
(Source: Food Safety of Turkey... from Farm to Table. For information on thawing other items, see The Big Thaw - Safe Defrosting Methods for Consumers.

The reference number of the Field Safety Notice on the NCMDR page, which begins with “mdprc” or Confirmation Code or the reference number of the authority where the Field Safety Notice is collected from .



هل استفدت من ما هو مقدم في هذه الصفحة؟
0 من الزوار ردوا بنعم من أصل0 مشاركة
السبب
السبب