Leading Regulatory Representative in Saudi Arabia

We can help you launch your product into the Saudi Market faster with our Regulatory Registration Solutions for Medical Devices.

Extensive Expertise and Proven Experience:

Bio-Standards was established in 2010 as a Regulatory Representative specializing in Product Registration with the Saudi Food & Drug Authority (SFDA) and local market access for international manufacturers of Medical Devices and Pharmaceuticals.
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Our team has in-depth knowledge of Saudi FDA Regulations and excels at navigating complex challenges to deliver optimal compliance and market access solutions. This allows us to create comprehensive strategies for all stakeholders to achieve seamless entry into the Saudi Market.

At Bio-Standards, we handle all sensitive tasks with the utmost professionalism, Integrity, Accuracy, and Transparency.
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135+

Project Completed

15

Years of experience

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Countries

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Manufacturers

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Products Registered

Our Services

Medical Device Importation & Distribution License

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

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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.

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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.

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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.

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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.

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National Center for Medical Devices Reporting (NCMDR)

The SFDA'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 Authorized Representative on behalf of the manufacturer.

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All Services

Why Bio-Standards

Deep Expertise, Proven Results

Our team comprises seasoned Regulatory Professionals with extensive knowledge of the Saudi FDA landscape, ensuring you navigate complexities with ease.

Tailored Solutions, Unwavering Support

We offer customized consultations and work closely with you, providing you with support in every step of the way to ensure your success.

Opening Horizons for Growth

We go beyond just compliance, unlocking your true potential in the Saudi Healthcare market and fostering sustainable growth.

Request a Free Consultation

Schedule a free consultation with our regulatory specialists and discuss your specific needs. We'll tailor a solution to ensure your smooth and successful market entry in Kingdom of Saudi Arabia.

Request Session Now