This application is essential for manufacturers seeking to get their Medical Devices products into Saudi Arabia, as it aids in determining the appropriate classification for their devices, clearing the necessary steps required for registering these products in strict accordance with regulations and requirements of Saudi Food and Drug Authority SFDA.
The Manufacturer is responsible for classifying the product according to SFDA rules and creating the necessary technical files.
Classification of Devices other than IVD Medical Devices
Manufacturer ascertaining the device’s classification by employing a set of classification rules grounded in:
▪ Intended Use: this information is typically obtained from : Instructions for Use (IFU), Label, Manufacturer’s advertising
materials, and Technical documentation
▪ Risk Assessment
▪ Degree of invasiveness in the human body
▪ Duration of Use
Classification of IVD Medical Devices
Manufacturer ascertaining the device’s classification by employing a set of classification rules grounded in:
▪ Using the classification rules for IVD medical devices, and
▪ Considering both the: Intended use of the device, Level of risk to the patient and public of an incorrect result.
| Service | Application Fee (SFDA Fees) |
|---|---|
Product Classification Application on PCS |
SAR 1,000 (≈USD 281.69) |
Required Documents
14 working days
Please use the form below to provide us with the necessary details. Get Proposal Our team will carefully review your request and will contact you shortly.
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Taryaki includes a cadre of experienced experts with specialized experience and knowledge in regulatory affairs and registration of medical devices and laboratory devices with the Saudi Food and Drug Authority, headquartered in Riyadh, Kingdom of Saudi Arabia.
