Product Classification System (PCS)

The Product Classification System (PCS) determines the registration path for various products, including drugs, food, and Medical Devices.

‍Identifying your product will be easier with Bio-Standards!

As a team, we know the complexities of the PCS and we can help you with the following:-

Identify the correct sector: Ensure your product follows the right regulations and registration requirements.

Resolve border-line cases: Get expert guidance when your product falls between two categories.

‍Don't Risk Delays or Non-Compliance

‍Let Bio-Standards guide you through the PCS and ensure a smooth, compliant registration process.

Timeline

The Saudi FDA takes approximately 1-2 weeks from the date of submission of the Product Classification System (PCS) application.

Validity

The official decision attained from the Product Classification System (PCS) is valid only for ONE YEAR.

Renewal / Update

- 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).