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What are the items that needs to have temperature indicators?

- In Vitro Medical Devices.

- Non Medical Reagents and Indicators.

what are the designated ports of Entries for Medical Devices?

Out of twenty seven ports of entries in the kingdom of Saudi Arabia, Medical Devices sector is currently located in nine ports only. The ports are listed as follows:

ports

 

If there are different classes of accessories belong to a medical device, can it be listed in one application?

Yes, if  the accessory has been manufactured for  the main medical device.

What does label mean?

‘Labeling’ means written, printed or graphic matter

A.    Affixed to a medical device or any of its containers or wrappers.

B.     Information accompanying a medical device, related to identification, technical description.

C.     Information accompanying a medical device, related to its use, but excluding shipping documents.

      What does accessory means?

       ‘Accessory’ means a product intended specifically by its manufacturer to be used together with a medical device to enable that medical device to achieve its intended purpose

      What is the National Center for Medical Devices Reporting (NCMDR)?

       

      NCMDR is devoted to receive the technical problem reports and feedback information about any medical devices malfunction from hospitals and healthcare facilities all around KSA, studying them and working together with manufacturers and suppliers to take the right action and assuring the proper safe performance.

      The center also aims to cooperate with the other international problem reporting centers to exchange reports received about medical devices used anywhere. Medical Devices Sector has membership of AHWP which works closely with Global Harmonization Task Force (GHTF).

       

      What is the medical device?

      Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

      Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

      • diagnosis, prevention, monitoring, treatment or allevi­ation of disease,
      • diag­nosis, monitoring, treatment, alleviation of or com­pensation for an injury e.g. disinfection substances , etc
      • inves­tigation, replacement, modification, or support of the anatomy or of a physiologi­cal process e.g. prescription eye glasses , aids for disabled/handicapped people, etc
      • supporting or sustaining life,
      • con­trol of conception,
      • disinfection of medical devices,
      • providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; 
        and which does not achieve its primary intended action in or on the human body by pharmaco­logical, immunological or metabolic means, but which may be assisted in its intended function by such means.

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