Services

SFDA Regulatory Services in Saudi Arabia

Bio-Standards serves as your entry point to the Saudi market, leveraging over 16 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.

Saudi FDA 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) in Saudi Arabia

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 Vigilance System

The Saudi FDA's NCMDR gathers and assesses data on medical device safety and performance, allowing stakeholders to report incidents for improved safety and compliance in Saudi Arabia by contacting the AR

Medical Device Advertising License (MDAL) in Saudi Arabia

We support manufacturers in obtaining MDAL approvals efficiently and compliantly ensuring your marketing activities align with Saudi FDA regulatory requirements and Saudi market standards.

Logistics & Supply Chain Compliance for Medical Devices in Saudi Arabia

We support manufacturers and distributors with MDEL & MDIL licensing, warehouse compliance, customs clearance coordination, regulatory alignment, and supply chain readiness ensuring smooth, compliant, and efficient market access in line with SFDA requirements.

Medical Device Importation into Saudi Arabia

Medical device and IVD manufacturers with end-to-end importation solutions in Saudi Arabia, including MDEL & MDIL licensing, customs clearance, FASAH compliance, and distributor coordination ensuring smooth and compliant market entry aligned with SFDA requirements.

Medical Device Technical File Preparation for SFDA Compliance

Navigating the complex regulations of medical device compliance with the SFDA is critical for market success. we specialize in preparing regulatory application files, ensuring your device's compliance journey is seamless.

Medical Device Risk Management Solutions

RMS are expertly designed to enhance product safety and ensure compliance with SFDA regulations and internal standards ISO 14971.

Biocompatibility Evaluation Solutions

BES is designed to guide medical device manufacturers through the essential process of demonstrating biocompatibility, ensuring adherence to stringent regulatory standards.

Usability Engineering Validation

We provide comprehensive Usability Engineering and Human Factors Validation services to ensure your medical device or IVD is safe, effective, and user-friendly for its intended users.

Production Process Validation Solutions for SFDA Compliance

They are designed to support medical device manufacturers in ensuring their products and manufacturing processes meet the stringent requirements set by the Saudi FDA, international regulatory bodies and, adhering to industry best practices.

Medical Device Stability and Shelf Life

We focus on the stability and shelf life of medical devices to ensure their long term safety and regulatory compliance.

Clinical Evaluation for Medical Devices

This ensure that your clinical research and data handling processes are efficient and compliant with stringent regulatory standards necessary for successful product validation

Performance Evaluation for In Vitro Diagnostic Devices (IVD)

We recognize that comprehensive performance evaluation is crucial for ensuring the safety and efficacy of In Vitro Diagnostic Devices (IVDs).

Post-Market Surveillance Solutions

We offer comprehensive Post-Market Surveillance (PMS) Solutions to monitor the safety and effectiveness of medical devices after market introduction.

Quality Management System (QMS) Services for Medical Devices & IVDs in Saudi Arabia

Our Quality Management System service solution is crafted to propel medical device and in vitro diagnostic device companies towards unmatched excellence and Saudi Food and Drug Authority (SFDA) compliance.

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.