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Product Classification

Classification, Registration system

Classifying a product into the appropriate regulatory category is one of the most important considerations when determining that product’s viability in Saudi Arabia

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  • •MDC is an on-line application to classify any product whether it is medical device or not.

 

WHY to classify ?

  • •To determine whether the product fall in medical device responsibilities or not.

 

WHO need to classify ?

  • Medical device establishments located in the Kingdom of Saudi Arabia. Manufacturers, Importers, Distributors who need help to determine if the product medical device or not.

 

HOW TO ENROL?

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  • 1.Enrol on-line through the SFDA website www.sfda.gov.sa

  • 2.Click on “Medical Devices”

  • 3.Click on the Medical Device Electronic Services MDES link

  • 4.Click on the MDC link

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Medical Device (single Use Device)

Medical Device ( In-Vitro Diagnostic)

Medical Device (Other Categories) 

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