- In Vitro Medical Devices.
- Non Medical Reagents and Indicators.
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:
Yes, if the accessory has been manufactured for the main medical device.
‘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.
‘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
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).
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: