OUR PARTICIPATION

IN

8 - 10 May 2017

Riyadh International Convention & Exhibition

Center, KSA

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  • Want to Sell your Device in Saudi Arabia?
  • Need assistance in finding local distributors ?
  • Need assistance with Saudi FDA Medical Device regulations ?
  • Are you looking local Authorized Representative for regulatory
    approval from Saudi Foods & Drug Authority (SFDA) ?
  • Need assistance in obtaining EU CE marketing or US approvals ?

Cosmetic Products

Registration with the

Saudi FDA

Hot Announcements

Authorized Representative
The first Independent Authorized representative in KSA adhering to the Saudi Food & Drug Authority (SFDA) and Medical Devices consultation in Saudi Arabia by highly experienced team specializing in SFDA regulations systems.
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Consultation Services
Medical Devices Registration in Saudi Arabia in order to achieve full compliance with SFDA and We assist with regulatory services such as classification, special access devices, and recalls.provides market reports product.
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IMDRF Approvals
All medical device and in-vitro classes require registration with SFDA, We assist our clients to attain regulatory approvals from Australia, Canada, Europe, Japan, and/or the USA through our international affiliations and offices.
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Cosmetic Consultation
We provide a professional consultation of cosmetic registration services in Saudi Arabia to ensure compliance of your cosmetic products with the Saudi FDA Standards and eCosma system according to their ingredient and claims.
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Medical Devices Distributor Search Services

Assists foreign manufacturers to find qualified and appropriate local distributors

FAQ’s

Does Bio-Standards also act as a distributor or has a business of such nature?
Why do we need to assign an Authorized Representative?
Who might be selected to assign as an Authorized Representative?
Is all the information that we place with Bio-Standards confidential?
What is Medical Devices Marketing Authorization (MDMA) and why is it important?
What is the given time to pay the MDMA application fee after requesting payment by SFDA?
What is the Medical Devices National Registry (MDNR) ?
Is it mandatory to register cosmetic products at SFDA before import?

 Why Us?

The First Independent Authorized Representative
We are the first authorized representative in Saudi Arabia, have been in the main stream with Saudi FDA since the beginning as we have been precisely following and enhancing our approaches and operations throughout all the developing phases of the Saudi FDA regulations and their implementations.
Over 100 International Medical Device Manufacturers
We are a licensed Authorized Representative for over 100 manufacturers, We have already gained considerable experience as a consulting firm in this newly formed regulatory system in the medical device sector with SFDA.
Professional Team
Our team members have the knowledge with SFDA regulations of Medical Devices & in-vitro diagnostics in detail and are skilled at working cooperatively with Saudi FDA staff to overcome difficult challenges and create comprehensive solutions in order to comply with the Saudi Regulation.
Our Clients
We take this opportunity to thank our esteemed clients for choosing Bio-Standards in order to provide them the finest medical device and Cosmetic products registration as regulatory service provider in Saudi Arabia with the Saudi Drug & Food Authority (SFDA). We promise keep motivated and inspired to help you succeed. Delivering results that exceed your expectations is our top priority. We are excited for the future and proud to welcome satisfied clientele and look forward to many years of working together.
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