Product Classification System (PCS) identifies the path to be followed for registration within each sector i.e. Drug, Food, Medical devices etc. with the SFDA.
This procedure is followed to determine the product’s concerned sector and relevant regulations and registration requirements especially if the device/product falls under the grey area. Whenever conflict arises between products at the borderline between two definitions, they will be classified on a case-by-case basis. SFDA’s judgment for the release of the decision is based on the scientific understanding of the product and its function and characteristics.
Product Classification System (PCS) Application takes withing 1-2 weeks from the date of application submission to receive the SFDA decision.
The validity of the official decision attained from the PCS is valid only for ONE YEAR.
- PCS Application Update option is not available: a new application needs to be submitted for additional devices.
- PCS Application Renewal option is not available: a new application needs to be submitted and the reference number of the old application can be used to get a similar decision (quickly/soon).
Appealing option is available where the manufacturer can refuse the decision provided by the SFDA with additional evidence /documentation.
| SERVICE | APPLICATION FEE |
| Classification Under PCS | SAR 1,000.00 |