Services

Experience The Best Services

Bio-Standards serves as your entry point to the Saudi market, leveraging over 14 years of experience to provide a wide range of services to manufacturers, facilitating seamless market entry.
We specialize in a range of services, such as Representation services, Regulatory and Compliance consulting, and support for customized registration processes. This is done by addressing your specific business needs and product requirements.

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Our Services

Medical Device Importation & Distribution License

Importing medical devices to KSA? Get the Medical Device Importation License efficiently with Bio-Standards.

Medical Device AR Licensing

Medical device manufacturers must appoint an authorized representative (AR) in Saudi Arabia before marketing their products in the country . ARs are responsible for pre- and post-marketing regulatory compliance.

Product Classification System (PCS)

This service offers companies the opportunity to classify their Products and determine the level of Registration required, aligning with the Saudi FDA standards.

Medical Device Marketing Authorization (MDMA)

Medical Device Marketing Authorization (MDMA) is the official approval granted by SFDA that allows companies to market and sell medical devices and In-Vitro Diagnostics (IVDs) in Saudi Arabia.

Medical Device - Unique Device Identification (UDI)

UDI system aims to document unique devices codes for medical devices based on accredited international standards, with the purpose to allow all stakeholders to identify medical devices information through the unique device identification code that is registered on the system.

Saudi Vigillance

Medical Device Advertising License

Logistics & Supply Chain Compliance

Importation

Documenting the Technical File Structure

Risk Management Solutions

Biocompatibility Evaluation Solutions

Usability Engineering Validation

Production Process Validation Solutions

Medical Device Stability and Shelf Life

Clinical Evaluation for Medical Devices

Performance Evaluation for In Vitro Diagnostic Devices (IVD)

Post-Market Surveillance Solutions

Quality Management System Solutions

As regulatory solutions providers, we offer a wide variety of services andproducts that assist our customers through every stage of the regulatoryprocess by simplifying, educating, and supporting them.