3 cups
Flour
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Butter
99% Success Rate • Experienced • Faster To Market
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RS boasts the highest success rate in the industry.
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More regulatory submissions than any other firm.
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Painless and streamlined licensing process.
We help companies bring safer, better products to market faster while reducing regulatory risk, As we are:
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Saudi Arabia Authorized Representative for Device Companies
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Medical Device Registration and Approval in Saudi Arabia
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Global Medical Device and IVD Compliance Experts
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Saudi Arabia Regulatory Strategy report
Medical Devices
The medical device category encompasses a wide range of instruments used in healthcare, which can be as simple as a toothbrush or as complex as a pacemaker.
Saudi Arabia Authorized Representative Medical Device Companies
Medical device manufacturers without a legal entity in the Kingdom of Saudi Arabia (KSA) must appoint a Saudi Arabia Authorized Representative. Your KSA Authorized Representative serves as a liaison between you and the Saudi Food & Drug Authority (SFDA), the country’s medical device regulator, but has many other responsibilities as well.
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.
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.
Marketing APPROVALS
All medical device classes require registration with SFDA, We assist our clients to attain marketing approvals from Australia, Canada, Europe, Japan, and/or the USA through our international affiliations and offices.
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.
Our Expertise
We are always exploring new solutions because the healthcare industry is always changing. User expectations evolve. More products rely on the internet than ever before. And medical devices are everywhere. Yet, we can help you meet the regulatory and safety demands of this industry to achieve market success
Our Services
Regulatory Standards is independent Authorized Representative and Medical Devices Regulatory Service provider in Saudi Arabia, Regulatory Standards is a KSA licensed Authorized Representative and is operated by a highly experienced team specializing in SFDA regulations & Systems.
According to Saudi Food & Drug regulations, Medical Device manufacturers who are not based in the kingdom of Saudi Arabia (KSA) must appoint a local Authorized Representative. The Authorized Representative act as a liaison between you and the kingdom of Saudi Arabia Food & Drug Authority(SFDA), as specified by the Medical Devices Interim Regulation(MDIR), Decree No. 8976. The Authorized Representative assumes regulatory representation for the products in the KSA Market and is responsible for submitting registration of your Device with the SFDA.
Medical Device Registration and regulations in Saudi Arabia is based on companies already having approval in one of the following reference markets: Australia, Canada, Europe, Japan, and/or the USA, and registration in one of these markets is mandatory in order to register in Saudi Arabia.
We are your strongest link in Saudi Arabia as Dealing with Saudi Food & Drugs Authority (SFDA), Compile Medical Device Marketing Authorization (MDMA), Post Market Surveillance, Inform SFDA of incidents outside KSA, Cooperate with the distributors and importers.
Medical Devices Registration
Regulatory Consultation
The Kingdom of Saudi Arabia has been rated in the top 20 most economically competitive countries in the world. With the government investment plans in the Health Care sector & stable economy, Saudi Arabia is always of key interest for international Medical Device Manufacturers planning to enter new markets.
The Kingdom of Saudi Arabia has been rated in the top 20 most economically competitive countries in the world. With the government investment plans in the Health Care sector & stable economy, Saudi Arabia is always of key interest for international Medical Device Manufacturers planning to enter new markets.
Reg-Standards offers regulatory consultation services to assist our clients comprehend the intent and the sanctions of the Saudi Food & Drug Authority (SFDA) regulations. We can support with getting the appropriate Medical Device classification, approval for Research and Educational purpose devices, and approval for Demonstration and Training purpose devices from the SFDA. As part to our consultation services, Reg-Standards provides clients with structured & reliable Medical Device Market Research Reports of Saudi Arabia. We can assist with the process of gathering, analyzing and interpreting information about Medical Device market, about a product or service to be offered for sale in that market, and about the past, present and potential customers for your Medical Devices, research into the characteristics, spending habits, location and needs of your business’s target market, the industry as a whole, and the particular competitors you face. Our team is always ready to assist local and foreign parties looking for guidance and support into the Medical Device Sector of Saudi Arabia.
Our Client
We take this opportunity to thank our esteemed clients for choosing Reg-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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To benefit from our services please note...
Medical Device Registration in Saudi Arabia is based on companies already having approval in one of the following reference markets: Australia, Canada, Europe, Japan, and/or the USA; and registration in one of these markets is mandatory in order to register in Saudi Arabia.
Per SFDA process, All medical devices & IVDs intended to be marketed in the Saudi Arabia should have a valid Medical Device Marketing Authorization (MDMA) as per the following enforcement dates.
Our services are based on medical devices regulation in Saudi Arabia in order to ensure your compliance with SFDA.
Thank you for taking the time to contact us.
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